Dental Health Products Inc

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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

Paper, Articulation (EFH) (4) Material, Tooth Shade, Resin (EBF) (3) Syringe, Restorative And Impression Material (EID) (2) Syringe, Periodontic, Endodontic, Irrigating (EIC) (1)

Premarket Exempt

No Yes

Clear

Health-Tec Temporary C&B Material 4:1 - D773110100011 Catalog Number : 110-10001

Device Description : Health-Tec Temporary C&B Material 4:1, Shade A1

Device Class : 1

Duns Number: 623191194

Premarket Exempt : No

Product Code : EFH

Prescription Use : Yes

Device Count : 1

Health-Tec Temporary C&B Material 4:1 - D773110100021 Catalog Number : 110-10002

Device Description : Health-Tec Temporary C&B Material 4:1, Shade A2

Device Class : 1

Duns Number: 623191194

Premarket Exempt : No

Product Code : EFH

Prescription Use : Yes

Device Count : 1

Health-Tec Temporary C&B Material 4:1 - D773110100031 Catalog Number : 110-10003

Device Description : Health-Tec Temporary C&B Material 4:1, Shade A3.5

Device Class : 1

Duns Number: 623191194

Premarket Exempt : No

Product Code : EFH

Prescription Use : Yes

Device Count : 1

Health-Tec Temporary C&B Material 4:1 - D773110100041 Catalog Number : 110-10004

Device Description : Health-Tec Temporary C&B Material 4:1, Shade B1

Device Class : 1

Duns Number: 623191194

Premarket Exempt : No

Product Code : EFH

Prescription Use : Yes

Device Count : 1

Health-Temporary C&B Material 1:1 - D77311032011 Catalog Number : 110-3201

Device Description : Health-Temporary C&B Material 1:1, Shade A1

Device Class : 2

Duns Number: 623191194

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Health-Temporary C&B Material 1:1 - D77311032021 Catalog Number : 110-3202

Device Description : Health-Temporary C&B Material 1:1, Shade A2

Device Class : 2

Duns Number: 623191194

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Health-Temporary C&B Material 1:1 - D77311032031 Catalog Number : 110-3203

Device Description : Health-Temporary C&B Material 1:1, Shade A3

Device Class : 2

Duns Number: 623191194

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Health-Tec/DHP Mixing Tips - D77311042011 Catalog Number : 110-4201

Device Description : Health-Tec/DHP Mixing Tips 1:1 Ratio Blue 50/pkg

Device Class : 1

Duns Number: 623191194

Premarket Exempt : Yes

Product Code : EID

Prescription Use : Yes

Device Count : 1

Health-Tec/DHP Syringes - D773130100011 Catalog Number : 130-10001

Device Description : Health-Tec/DHP Utility Syringes 12cc 50/box

Device Class : 1

Duns Number: 623191194

Premarket Exempt : Yes

Product Code : EID

Prescription Use : Yes

Device Count : 1

Health-Tec/DHP Syringes - D773130100021 Catalog Number : 130-10002

Device Description : Health-Tec/DHP Luer Lock Endo Syringes 3cc 100/box

Device Class : 1

Duns Number: 623191194

Premarket Exempt : Yes

Product Code : EIC

Prescription Use : Yes

Device Count : 1

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