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SpofaDental - earesing yourpractee.
‘AKerr Company
Declaration of Conformity
Manufacturer Name and SpofaDental a.s.
iC 63099407
Address: Markova 238, 506 01 Jiin, Czech Republic
Product Tradenamets}: Disclosing Wax
Device Category: Dental laboratory wax
Classification and Rule(s): The product is not classified as a medical device.
Declaration Statemer
According to Sect. 12 and Sect. 13 of Law 22/1997 Coll. as amended - of Technical Requirements for
Products the manufacturer hereby declares in sole responsibility that the product conforms to the basic
requirements and with ordinary use, itis safe for its purpose of use. The manufacturer has implemented
‘measures to guarantee conformity of all products introduced to the market, to their technical
documents and to the basic requirements,
To evaluate the basic properties of the product in a specified manner, procedure according to the Law
22/1997 Coll. as amended, was applied.
Device Identification: REF, Description
35118 Disclosing Wax-non dental
‘Signed for and on behalf of Manufacturer: SpofaDental a.s.
/)
—
sigin 16.11.2020 L j \
Place Date of Issue Mer. Jarostav Adolf )
Quality Manager
SpofaDeftai a.s.
16 01 Bigin
1 Beccoour ne Banc Aiongealcat ise Prog
Foc 420400 6 Dé czsseo7 (Gax: 3128700018/7910, IRAN: Cz
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