Alphadent NV

Address:MANNEBEEKSTRAAT 33,WAREGEM West-Vlaanderen,BE

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

ATTACHMENT, PRECISION, ALL (EGG) (2) ACCESSORIES, RETRACTOR, DENTAL (EIF) (1)

Premarket Exempt

No Yes

Clear

CEKA & PRECI-LINE ATTACHMENTS - 14260576944006 Catalog Number : RE H 17

Device Description : PROTECTION CAP M2 2 PCS

Device Class : 1

Duns Number: 283174985

Premarket Exempt : Yes

Product Code : EGG

Prescription Use : Yes

Device Count : 2

CEKA & PRECI-LINE ATTACHMENTS - 14260576944013 Catalog Number : RE H 21

Device Description : WHEEL BURR 2 PCS

Device Class : 1

Duns Number: 283174985

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : Yes

Device Count : 2

CEKA & PRECI-LINE ATTACHMENTS - 14260576944020 Catalog Number : RE H 4

Device Description : REVAX M2 SOLDERING ACC. AXIAL 2 PCS

Device Class : 1

Duns Number: 283174985

Premarket Exempt : Yes

Product Code : EGG

Prescription Use : Yes

Device Count : 2

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