WHIP-MIX CORPORATION

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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

Articulators (EJP) (7) Facebow (KCR) (3)

Premarket Exempt

No Yes

Clear

Hanau 96 H2 Articulator - D0400033020001 Catalog Number : 003302-000

Device Description : A dental articulator is a device designed to simulate all or part of the mandibu

Device Class : 1

Duns Number: 006385173

Premarket Exempt : Yes

Product Code : EJP

Prescription Use : Yes

Device Count : 1

Hanau Earpiece Facebow - D0400088240001 Catalog Number : 008824-000

Device Description : A facebow is a device intended for use in a dental diagnostic procedure to recor

Device Class : 1

Duns Number: 006385173

Premarket Exempt : Yes

Product Code : KCR

Prescription Use : Yes

Device Count : 1

Hanau-Mate Non-Adjustable Articulator - D0400098560001 Catalog Number : 009856-000

Device Description : A dental articulator is a device designed to simulate all or part of the mandibu

Device Class : 1

Duns Number: 006385173

Premarket Exempt : Yes

Product Code : EJP

Prescription Use : Yes

Device Count : 1

Hanau Spring Bow Facebow - D040010328001 Catalog Number : 010328-000

Device Description : A facebow is a device intended for use in a dental diagnostic procedure to recor

Device Class : 1

Duns Number: 006385173

Premarket Exempt : Yes

Product Code : KCR

Prescription Use : Yes

Device Count : 1

Hanau Spring Bow Facebow - D0400103510001 Catalog Number : 010351-000

Device Description : A facebow is a device intended for use in a dental diagnostic procedure to recor

Device Class : 1

Duns Number: 006385173

Premarket Exempt : Yes

Product Code : KCR

Prescription Use : Yes

Device Count : 1

Hanau Wide-Vue Articulator - D0400108850001 Catalog Number : 010885-000

Device Description : A dental articulator is a device designed to simulate all or part of the mandibu

Device Class : 1

Duns Number: 006385173

Premarket Exempt : Yes

Product Code : EJP

Prescription Use : Yes

Device Count : 1

Hanau modular Articulator - D0400141020001 Catalog Number : 014102-000

Device Description : A dental articulator is a device designed to simulate all or part of the mandibu

Device Class : 1

Duns Number: 006385173

Premarket Exempt : Yes

Product Code : EJP

Prescription Use : Yes

Device Count : 1

Hanau modular Articulator - D0400141160001 Catalog Number : 014116-000

Device Description : A dental articulator is a device designed to simulate all or part of the mandibu

Device Class : 1

Duns Number: 006385173

Premarket Exempt : Yes

Product Code : EJP

Prescription Use : Yes

Device Count : 1

Hanau modular Articulator - D0400143000001 Catalog Number : 014300-000

Device Description : A dental articulator is a device designed to simulate all or part of the mandibu

Device Class : 1

Duns Number: 006385173

Premarket Exempt : Yes

Product Code : EJP

Prescription Use : Yes

Device Count : 1

Hanau modular Articulator - D0400143090001 Catalog Number : 014309-000

Device Description : A dental articulator is a device designed to simulate all or part of the mandibu

Device Class : 1

Duns Number: 006385173

Premarket Exempt : Yes

Product Code : EJP

Prescription Use : Yes

Device Count : 1

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