IPB

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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

Material, Impression (ELW) (5) Attachment, Precision, All (EGG) (3) Accessories, Retractor, Dental (EIF) (2) Dam, Rubber (EIE) (2)

Premarket Exempt

Yes

Clear

PrimeLoc - 00810053770481 Catalog Number :

Device Description : 21mm Abutment Driver, Packaged, Primeloc Attachment System

Device Class : 1

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : Yes

Device Count : 1

PrimeLoc - 00810053770498 Catalog Number :

Device Description : Latch Abutment Driver, Packaged, Primeloc Attachment System

Device Class : 1

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : Yes

Device Count : 1

PrimeLoc - 00810053770504 Catalog Number :

Device Description : Processing Insert, 4 Pack

Device Class : 1

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : EGG

Prescription Use : Yes

Device Count : 1

PrimeLoc - 00810053770511 Catalog Number :

Device Description : Extended Range Processing Pack with Enhanced Denture Housing, 2 Pack

Device Class : 1

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : EGG, EIE

Prescription Use : Yes

Device Count : 1

PrimeLoc - 00810053770528 Catalog Number :

Device Description : Extended Range Processing Pack with Enhanced Denture Housing, 10 Pack

Device Class : 1

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : EGG, EIE

Prescription Use : Yes

Device Count : 1

ValuLine - 00810053770535 Catalog Number :

Device Description : Benco Bite Registration Regular Set, 2 Pack

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

ValuLine - 00810053770542 Catalog Number :

Device Description : Benco Bite Registration Fast Set, 2 Pack

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

ValuLine - 00810053770603 Catalog Number :

Device Description : Benco Bite Registration Super Fast Set, 2 Pack

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

ValuLine - 00810053770610 Catalog Number :

Device Description : Benco Bite Registration Rigid Fast Set, 2 Pack

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

ValuLine - 00810053770627 Catalog Number :

Device Description : Benco Bite Registration Clear Bite, 2 Pack

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

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