DECLARATION OF CONFORMITY

We, BIOHORIZONS IMPLANT SYSTEMS, INC. also trading as BIOHORIZONS, hereby declare
that the below mentioned devices have been classified according to the classification rules and conform to
the Essential Principles for Safety and Performance as laid out in the ASEAN Agreement on Medical
Device Directive.

Name and Address of Product Owner:

BIOHORIZONS IMPLANT SYSTEMS, INC. 2300 RIVERCHASE CENTER BIRMINGHAM, AL
USA 35244

Name and Address of Physical Manufacturer:

BIOHORIZONS IMPLANT SYSTEMS, INC. 2300 RIVERCHASE CENTER BIRMINGHAM, AL
USA 35244

Name and Address of Authorized Representative:

Dentapex Corporation Limited
128/146 Payathai Plaza Building ,Floor 13th, Payathai Road,
ThungPayathai, Rajthevee, Bangkok 10400
Tel: 662-216-1688-89 Fax: 02-612-9042

Medical Device(s):
Number Item Number Item Name
1 MU-HAM Multi-unit manual hex adapter
2 MU-HAH Multi-unit handpiece hex adapter
3 MU-HAR Multi-unit 4mm square hex adapter
4 TD-20 Tapered Surgical Drill, Grey, 2.0mm
5 TD-25 Tapered Surgical Drill, Grey, 2.5mm
6 TD-28 Tapered Surgical Drill, Purple, 2.8mm
7 TD-32 Tapered Surgical Drill, Yellow, 3.2mm
8 TD-37 Tapered Surgical Drill, Green, 3.7mm
9 R-4MM Ratchet
10 DE-ISO Drill Extender

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11 RE-4MM Ratchet and Hand Wrench Extender
12 HW-4MM Hand Wrench
13 PP-2025 Straight Parallel Pin
14 ID-GY-ISO Grey Implant Driver, Handpiece, Regular
15 ID-GY-4MM Grey Implant Driver, 4mm Square, Regular
16 ID-YW-ISO Yellow Implant Driver, Handpiece, Regular
17 GD-2024 Guided Drill, Grey, 2.0 x 24mm
18 GD-2517 Guided Drill, Grey, 2.5 x 17mm
19 GD-2521 Guided Drill, Grey, 2.5 x 21mm
20 GD-2524 Guided Drill, Grey, 2.5 x 24mm
21 GD-2528 Guided Drill, Grey, 2.5 x 28mm
22 GD-2821 Guided Drill, Purple, 2.8 x 21mm
23 GD-2824 Guided Drill, Purple, 2.8 x 24mm
24 GD-2828 Guided Drill, Purple, 2.8 x 28mm
25 GD-3217 Guided Drill, Yellow, 3.2 x 17mm
26 GD-3221 Guided Drill, Yellow, 3.2 x 21mm
27 GD-3224 Guided Drill, Yellow, 3.2 x 24mm
28 GD-3228 Guided Drill, Yellow, 3.2 x 28mm
29 GD-3717 Guided Drill, Green, 3.7 x 17mm
30 GD-3721 Guided Drill, Green, 3.7 x 21mm
31 GD-3724 Guided Drill, Green, 3.7 x 24mm
32 GD-3728 Guided Drill, Green, 3.7 x 28mm
33 DG-YW-25 Drill Guide, Yellow, 2.5mm Drill
34 DG-YW-28 Drill Guide, Yellow, 2.8mm Drill
35 DG-YW-32 Drill Guide, Yellow, 3.2mm Drill
36 DG-GN-25 Drill Guide, Green, 2.5mm Drill
37 DG-GN-32 Drill Guide, Green, 3.2mm Drill
38 DG-GN-37 Drill Guide, Green, 3.7mm Drill
39 DG-GN-41 Drill Guide, Green, 4.1mm Drill
40 GS-4SC Guided Surgery Driver 4mm Square Drive Converter
41 GS-FP Guided Surgery Fixation Pin
42 GS-GY-ID Grey Guided Surgery Implant Driver
43 GS-YW-ID Yellow Guided Surgery Implant Driver
44 GS-DDS Guided Surgery Disposable Depth Stop
45 GS-DH Guided Surgery Depth Stop Handle
46 GS-FPS Guided Surgery Fixation Pin Sleeve (pack of 10)
47 GS-GC-P Guided Cylinder, Pilot (pack of 10)
48 GS-GC-YW Guided Cylinder, Yellow (pack of 10)
49 GS-GC-GN Guided Cylinder, Green (pack of 10)

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 50 HD-ISO .050 Hex Driver, Handpiece
51 HD-4MMS .050 Hex Driver, 4mm Square, Short
52 HD-4MML .050 Hex Driver, 4mm Square, Long
53 BP-GY Bone Profiler, Grey
54 BP-YW Bone Profiler, Yellow
55 PD-15 Pilot Drill, 1.5mm
56 IL-SK Surgical Kit (populated)
57 IL-ST Surgical Tray (empty)
58 TD-41 4.1mm drill
59 TD-45 4.5mm drill
60 IL-GK Guided Kit (populated)
61 IL-GT Guided Tray (empty)
62 DG-GN-45 Drill Guide, Green, 4.1mm Drill
63 GD-4117 Guided Drill, Red, 4.1 x 17mm
64 GD-4121 Guided Drill, Red, 4.1 x 21mm
65 GD-4124 Guided Drill, Red, 4.1 x 24mm
66 GD-4128 Guided Drill, Red, 4.1 x 28mm
67 GD-4517 Guided Drill, Blue, 4.5 x 17mm
68 GD-4521 Guided Drill, Blue, 4.5 x 21mm
69 GD-4524 Guided Drill, Blue, 4.5 x 24mm
70 GD-4528 Guided Drill, Blue, 4.5 x 28mm
71 MDLSPDZ MDL Single Patient Drill, Ø1.2mm
72 MDLCADZ Mini Drive-Lock Contra Angle Driver
73 MDLRDZ MDL/MILO Ratchet Driver
74 MDLRDLZ Mini Drive-Lock Ratchet Driver, Long
75 R-4MM Ratchet
76 HW-4MM Hand Wrench
77 LDZ Locator Drill
78 D1515Z Pilot Twist Drill Ø1.5 x 15mm
79 D2015Z Pilot Twist Drill Ø2.0 x 15mm
80 D25Z Tri-Spade Drill Ø2.5 x 15mm

Risk Classification: e.g. Class B, rule

Class 2 rule 5

Quality Management System Certificate:

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BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 345 080 9000
Issue Date: 2022-Oct-11, Expiry Date: 2025-Oct-23

Standards Applied:
CE 622148 - EC Certificate - Full Quality Assurance System

This declaration of conformity is valid from: 24 April 2023

Authorized Signatory:

___________________________ _____________
Bill Hornbuckle Date
Manager, Regulatory Affairs
BioHorizons Implant Systems, Inc

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