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) (10)

Premarket Exempt

No Yes

Clear

CEKA & PRECI-LINE ATTACHMENTS - 04260576940148 Catalog Number : 1106AB

Device Description : Preci-Clip Rider LA Stainless Steel

Device Class : 1

Duns Number: 283174985

Premarket Exempt : Yes

Product Code : EGG

Prescription Use : Yes

Device Count : 1

CEKA & PRECI-LINE ATTACHMENTS - 04260576940155 Catalog Number : 1125

Device Description : Preci-Clip Rider OC Orax alloy

Device Class : 1

Duns Number: 283174985

Premarket Exempt : Yes

Product Code : EGG

Prescription Use : Yes

Device Count : 1

CEKA & PRECI-LINE ATTACHMENTS - 04260576940162 Catalog Number : 1126

Device Description : Preci-Clip Rider Stainless Steel

Device Class : 1

Duns Number: 283174985

Premarket Exempt : Yes

Product Code : EGG

Prescription Use : Yes

Device Count : 1

CEKA & PRECI-LINE ATTACHMENTS - 04260576940179 Catalog Number : 1201

Device Description : Preci-Ball Standard Or/Or

Device Class : 1

Duns Number: 283174985

Premarket Exempt : Yes

Product Code : EGG

Prescription Use : Yes

Device Count : 1

CEKA & PRECI-LINE ATTACHMENTS - 04260576940186 Catalog Number : 1201 A

Device Description : Preci-Ball Female orax alloy

Device Class : 1

Duns Number: 283174985

Premarket Exempt : Yes

Product Code : EGG

Prescription Use : Yes

Device Count : 1

CEKA & PRECI-LINE ATTACHMENTS - 04260576940193 Catalog Number : 1201 D

Device Description : Preci-Ball/Clix male analogue

Device Class : 1

Duns Number: 283174985

Premarket Exempt : Yes

Product Code : EGG

Prescription Use : Yes

Device Count : 1

CEKA & PRECI-LINE ATTACHMENTS - 04260576940209 Catalog Number : 1201 P

Device Description : Preci-Ball/clix paralleling mandrel Male

Device Class : 1

Duns Number: 283174985

Premarket Exempt : Yes

Product Code : EGG

Prescription Use : Yes

Device Count : 1

CEKA & PRECI-LINE ATTACHMENTS - 04260576940216 Catalog Number : 1205

Device Description : Preci-Ball PC

Device Class : 1

Duns Number: 283174985

Premarket Exempt : Yes

Product Code : EGG

Prescription Use : Yes

Device Count : 1

CEKA & PRECI-LINE ATTACHMENTS - 04260576940223 Catalog Number : 1205 A

Device Description : Preci-Ball Female Titanax alloy

Device Class : 1

Duns Number: 283174985

Premarket Exempt : Yes

Product Code : EGG

Prescription Use : Yes

Device Count : 1

CEKA & PRECI-LINE ATTACHMENTS - 04260576940230 Catalog Number : 1205 C

Device Description : Preci-Ball/Clix Male PA

Device Class : 1

Duns Number: 283174985

Premarket Exempt : Yes

Product Code : EGG

Prescription Use : Yes

Device Count : 1

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