COSMEDENT, INC.

Address:4646 N. RAVENSWOOD AVE.,CHICAGO,IL,60640,US

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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

Coating, Filling Material, Resin (EBD) (5) Syringe, Restorative And Impression Material (EID) (3)

Premarket Exempt

No Yes

Clear

CosmeCore IntraOral Tips - D77920330211 Catalog Number :

Device Class : 1

Duns Number: 113911689

Premarket Exempt : Yes

Product Code : EID

Prescription Use : Yes

Device Count : 1

White Plastic Nozzle Tips - D77920340213 Catalog Number :

Device Class : 1

Duns Number: 113911689

Premarket Exempt : Yes

Product Code : EID

Prescription Use : Yes

Device Count : 1

CosmeCore 50g Tip Package - D77920350315 Catalog Number :

Device Class : 1

Duns Number: 113911689

Premarket Exempt : Yes

Product Code : EID

Prescription Use : Yes

Device Count : 1

Flowable Microfill Basic Kit - D7793010053 Catalog Number : 301005

Device Description : Flowable Microfill Basic Kit includes 11 (3 g) syringes of Flowable Microfill, a Flowable Microfill Basic Kit includes 11 (3 g) syringes of Flowable Microfill, and 50 tips (25 - 18 gauge, 25 - 19 gauge) in the Tray.

Device Class :

Duns Number: 113911689

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Flowable Microfill Start Kit - D7793011053 Catalog Number : 301105

Device Description : Flowable Microfill Start Kit includes 5 (3 g) syringes of Flowable Microfill, an Flowable Microfill Start Kit includes 5 (3 g) syringes of Flowable Microfill, and 30 tips (15 - 18 gauge, 15 - 19 gauge) in the Tray.

Device Class :

Duns Number: 113911689

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Renamel® Flowable Microfill - D77930110W0 Catalog Number : 30110W

Device Class : 2

Duns Number: 113911689

Premarket Exempt : No

Product Code : EBD

Prescription Use : Yes

Device Count : 1

Renamel® Flowable Microfill - D7793011A10 Catalog Number : 3011A1

Device Class : 2

Duns Number: 113911689

Premarket Exempt : No

Product Code : EBD

Prescription Use : Yes

Device Count : 1

Renamel® Flowable Microfill - D7793011A20 Catalog Number : 3011A2

Device Class : 2

Duns Number: 113911689

Premarket Exempt : No

Product Code : EBD

Prescription Use : Yes

Device Count : 1

Renamel® Flowable Microfill - D7793011A30 Catalog Number : 3011A3

Device Class : 2

Duns Number: 113911689

Premarket Exempt : No

Product Code : EBD

Prescription Use : Yes

Device Count : 1

Renamel® Flowable Microfill - D7793011A40 Catalog Number : 3011A4

Device Class : 2

Duns Number: 113911689

Premarket Exempt : No

Product Code : EBD

Prescription Use : Yes

Device Count : 1

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