2011.06.

13 QM team
 Sand-blasted with Large grite and Acid etched surface
This treatment is the method that blasts HA particle(smaller than 50 ㎛) to
surface of machined implant for making roughness. And then, it does acid
etching.
Due to Acid ingredient to surface of implant, it makes micro pore in macro
pore, so that contact area with bone is larger, and facilitate cell activation.
This treatment causes short treatment period, and high probability of
success.

Macro pore and Micro pore

make contact area larger, and
help movement of blood flow.
SLA Surface Treatment Process

Manufacturing → Primary Cleansing → Secondary Cleansing → Lot Test

(identifying Appearance / Size , Condition of Manufacturing)

→ Tertiary Cleansing→ Drying Process → Surface Treatment [Blasting : →

Cleansing] →

The fourth Cleansing → Surface Treatment → Final cleansing (Dual

cleansing)
Biocompatibility of SLA
1. Cytotoxicity

Test Regulation

ISO 10993-05 Biological Evaluation of Medical Devices Part5 Test

for invitro cytotoxicity
8.4 Test by indirect contact
8.4.1 Agar diffusion test
ISO 7405 Dentistry
-Preclinical evaluation of biocompatibility of medical devices
used in dentistry
-Test methods for dentalmaterials 6.1Agardiffusiontest
Biocompatibility of SLA
1. Cytotoxicity

Test Purpose

To evaluate existence of cytotoxicity which is dissolved from medical

device.
Biocompatibility of SLA
Test 1. Range of cell dissolution

Negative Control Group : Positive Control Group :

Al2O3 disc – 0 mm Polyurethane film – 3 mm

Test Control Group : SLA treatment surface of Implant – 0 mm

Biocompatibility of SLA
Test 2. Cell Dissolution Probability

Dissolution Probability within

a range of cell dissolution : 0 %
Biocompatibility of SLA
Test Result

Test Judgment Criteria : Cytotoxicity Reaction Index

- Cell Dissolution Range Index / Cell Dissolution Reaction Index

Test Conclusion :
- Cell Dissolution Range Index / Cell Dissolution Reaction Index = 0 / 0
No Toxicity from sample is observed.
Biocompatibility of SLA
2. Acute Toxicity (I.V Test)

Test Criteria

ISO 10993-11:2006 Biological Evaluation of MedicalDevices

ASTM F750-87 Standard Practice for Evaluating Material Extracts by

Systemic Injection in the Mouse(2002)

USP24NF19<88> Biological Reactivity Tests, InVivo Systemic

Injection test
Biocompatibility of SLA
2. Acute Toxicity (I.V Test)

Test Purpose

To evaluate Acute Toxicity of material which is dissolved from the

medical device.
Biocompatibility of SLA
Test Result
Test Group (Polar solvent)

Test animal 1 Test animal 2

Test animal 3 Test animal 4

Test animal 5 Test animal Total

Biocompatibility of SLA
Test Result

Test Judgment Standard :

After testing at Equal pulse and Abdominal, we observed whether

test group has Acute Toxicity compared with control group during
test period.

Test Conclusion :

After test, there isn`t dead or reduced weight in excess of standard,

therefore we judged that it doesn`t have Acute Toxicity.
Biocompatibility of SLA
3. Local Lymph Node Assay(LLNA)

Test Regulation

ISO 10993-10(2010) Biological Evaluation of Medical Devices

Part10.Test for Irritation and skin
sensitization ;7.2.Murine
Local Lymph Node Assay(LLNA)

OECD 442B(2010) OECD Guide line for the Testing of Chemicals;

Skin Sensitization Local Lymph Node Assay
:BrdU-ELISA
Biocompatibility of SLA
3. Local Lymph Node Assay(LLNA)

Test Purpose

To evaluate Stimulation and Sensitization Reaction about compound

which could be flew out and existent in material of the medical
device.
Biocompatibility of SLA
Test Result

Evaluation 1. Optical Density Value

Biocompatibility of SLA
Test Result

Evaluation 2. Stimulation Value

Stimulation Index Criteria : 1.6

Biocompatibility of SLA
Test Result

Test Judgment Standard :

After comparing average proliferation of control group with average
proliferation of test group, it is not suitable if the ratio(SI) of those is
more than 1.6.

Test Conclusion : SI – 0.81

The result of stimulation reaction test for un-absorptiveness of
residual particle destruction material, and acid material which could
be remain in porus texture, no sensitization was observed, therefore
sensitization reaction for skin is safe.
Biocompatibility of SLA
4. Pyrogeniciry

Test Regulation

ISO 10993-11 Biological evaluation of medical devices(2006 2nd. edition)

Part11.Testforsystemictoxicity
AnnexF. Information on materials – mediated pyrogens

Test Purpose

To evaluate possibility of causing pyrexy in material which can be dissolved

from dental device
Biocompatibility of SLA
Test Result

T
e
m
p
e
r
a
t
u
r
e
Elapsed Time (Time)
Biocompatibility of SLA
Test Result

Test Judgment Standard :

If there is no test animal whose body heat is more than 0.5 ℃, we
judged that it is pyrogenic material negative.

Test Conclusion :
No pyrexy was observed from 3 test animals for SLA Implant elution
liquid.
Biocompatibility of SLA
5. Intradermal Intracutaneous reation

Test Regulation

ISO 10993-10 Biological evaluation of medical devices

Part10.Test for Irritation and Delayed-type hypersensitivity

Test Purpose

To evaluate Intradermal Instracutaneous reaction for material which

could be dissolved from medical device.
Biocompatibility of SLA
Test Result
Image 1. right after injecting test material
Biocompatibility of SLA
Test Result

Image 2. after 24 hourss

Biocompatibility of SLA
Test Result
Image 3. after 48 hours
Biocompatibility of SLA
Test Result

Image 4. after 72 hours

Biocompatibility of SLA
Test Result
Test animal 1
Right after Injection After 24 Hours After 48 Hours After 72 Hours

Erythema Edema Total Erythema Edema Total Erythema Edema Total Erythema Edema Total

Test Group 0 0 0 0 0 0 0 0 0 0 0 0
Polar Solvent
Control Group 0 0 0 0 0 0 0 0 0 0 0 0

Test Group 0 0 0 0 0 0 0 0 0 0 0 0
Non-polar Solvent
Control Group 0 0 0 0 0 0 0 0 0 0 0 0

Test animal 2
Right after Injection After 24 Hours After 48 Hours After 72 Hours

Erythema Edema Total Erythema Edema Total Erythema Edema Total Erythema Edema Total

Test Group 0 0 0 0 0 0 0 0 0 0 0 0
Polar Solvent
Control Group 0 0 0 0 0 0 0 0 0 0 0 0

Test Group 0 0 0 0 0 0 0 0 0 0 0 0
Non-polar Solvent
Control Group 0 0 0 0 0 0 0 0 0 0 0 0

Test Material Elution pH : 6.54 (Polar Solvent)

< Difference of Intraderrmal reaction average score>

Test animal 1. Test animal 2.
Right after Injection (Polar Solvent, Non-polar Solvent) 0.0, 0.0 0.0, 0.0
After 24 hours (Polar Solvent, Non-polar Solvent) ) 0.0, 0.0 0.0, 0.0
After 48 hours (Polar Solvent, Non-polar Solvent) ) 0.0, 0.0 0.0, 0.0
After 72 hours (Polar Solvent, Non-polar Solvent) ) 0.0, 0.0 0.0, 0.0
Biocompatibility of SLA
Test Result

Test Judgment Standard :

We compared control group with average reaction score.

Test Conclusion :
Anything causing stimulation was not observed from SLA Implant
elution liquid.
Biocompatibility of SLA
5. Implantation

Test Regulation

ISO 10993-6 Biological evaluation of medical devices(2007)

Part6.Test for Local Effects after Implantation
6 Tests method for Implantation in Bone

Test Purpose

To evaluate implantation reaction of medical device.

Biocompatibility of SLA
Test Result

Test Judgment Standard

Through comparing visual inspection result with histopathological inspection
result, we evaluated overall biological reaction, and then judged finally.

a. Evaluation about visual effect : Through low-power objective lens, we observed and evaluated
shape of grafting sample and adjacent tissue.
b. Evaluation about histopathological effect
① Fibrosis / Fibrous tunicate and infection
② Atrophy or Denaturalization from histomorphological change.
③ Infection Cell and distribution shape which are distributed at grafting sample and contact surface
④ Bone necrosis from cell nucleus remains or Capillary destruction
c. Evaluation about biological reaction : Through comparing visual inspection result with histopathological
inspection result, we evaluated overall biological effect, and then judged finally.
d. Distance of new osteogenesis formation
 Biocompatibility of SLA
Test Result

Test Sample : Test Group - NIS4510A(Lot No. 20110308)

Control Group - EB313(Lot No. REB1006002NB)

1. Evaluation about visual inspection : No change at implanting sample and adjacent tissue.
2. Evaluation about histopathological inspection :
Osseointegration was completed without gap between contact part of grafting sample and
normal tissue.
3. . Evaluation about biological reaction :
Result of visual inspection and histopathological inspection, there was no latent biological
harmful reaction.
4. Distance of new osteogenesis formation : There was no statistical significant difference between new distance of
osteogenesis formation of test group, and control group.

Distance Average (㎜) Deviation C.V.(%)

Test Group 2.114 0.451 21.35

Control Group 2.119 0.363 17.12

p value p > 0.05 (p=0.997)

Biocompatibility of SLA
Control Group

NB Newly formed bone

F Fixture

BM Bone marrow

Distance of new osteogenesis formation – Left : 1.976㎜, Right : 2.35㎜

Biocompatibility of SLA
Test Group

NB Newly formed bone

F Fixture

BM Bone marrow

Distance of new osteogenesis formation– Left : 2.460㎜, Right : 2.41㎜

시험결과

Biocompatibility of SLA

Test Conclusion :

Through the test for the implant – NIS4510A with SLA Surface
Treatment -, we observed osseointegration without harmful reaction
by implanting in osseous tissue. Therefore we judged that the
implant is safe for implanting in osseous tissue.
 Performance of SLA
1. Shearing Compression Load

Test Regulation

ISO 14801 Biological evaluation of medical devices(2006 2nd. edition)

Part11.Testforsystemictoxicity
AnnexF. Information on materials – mediated pyrogens

Test Purpose

To measure flank load between Fixture, Abutment, and Screw

 Performance of SLA
Test Result

[SLA] BIS 4011A-2 + ISAH 417 – Average : 890.6 N

 Performance of SLA
Test Result

[RBM] BIS 4011 + ISAH 417 – Average : 896.7 N

 Performance of SLA
Test Result

Test Judgment Standard :

Through comparing Shearing load value of RBM surface-treated

implant with Shearing load value of SLA surface-treated implant, we
identified whether there is significant difference.

Test Conclusion :

With considering Control Group(RBM) and Standard Deviation(± 4.3),

we judged that there is no significant difference.
Surface Characteristic of SLA
1. Contact Angle (Surface Hydrophilicity)

Test Regulation

ASTM D 5946 Standard Test Method for Corona Treated Polymer

Films Using Water Contact Angle Measurements

Test Purpose

To judge tendency of Hydrophile Property and Hydrophobicity through

measuring Contact Anlge between Surface and Test Solution
Surface Characteristic of SLA
Contact Angle : This angle is made when liquid is parallel to solid
thermodynamically. Moreover, it is also criterion which
instructs wettability of solid surface

Contact Angle

Gas

Liquid

Solid
Surface Characteristic of SLA
Test Result

1. # 1 Condition of Surface Treatment

HCl : H2SO4 : H2O = 3.5 : 3.5 : 3 , 90 ℃, 5 min

Left of the sample Center of the sample Right of sample

101.1° 100.1° 99.3°

Surface Characteristic of SLA
Test Result

2. # 2 Condition of Surface Treatment

HCl : H2SO4 : H2O = 3.5 : 3.5 : 3 , 90 ℃, 5 min + NaOH 35 ℃, 30 min

Left of the sample Center of the sample Right of sample

56.1° 46.2° 52.7°

Surface Characteristic of SLA
Test Result

3. # 3 Condition of Surface Treatment - RBM

Left of the sample Center of the sample Right of sample

86.3 92.2 93.3

Surface Characteristic of SLA
Test Result

Test Judgment Standard:

Low contact angle : High wettability(Hydrophilicity)

High contact angle : Row wettability (Hydrophobicity)

Test Conclusion : Sample Contact angle(θ)

SLA 100.18
SLA + NaOH 51.66
RBM 90.60

SLA < RBM < SLA + NaOH