DENTONICS INC

Address:2833 TOPHILL RD.,MONROE,NC,28110,US

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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

Premarket Exempt

No Yes

Clear

MASTER-DENT - 00816526021838 Catalog Number :

Device Description : Bite Registration, Regular Set HP, (2x50ml Cartridges w/ tips)

Device Class :

Duns Number: 186285342

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

MASTER-DENT - 00816526021845 Catalog Number :

Device Description : Bite Registration, Fast Set HP, (1 x 50ml Cartridge)

Device Class :

Duns Number: 186285342

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

MASTER-DENT - 00816526021852 Catalog Number :

Device Description : Bite Registration, Fast Set HP, (2x50ml Cartridges w/ tips)

Device Class :

Duns Number: 186285342

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

MASTER-DENT - 00816526021906 Catalog Number : 10-000-KW

Device Description : Zinc Phosphate Cement, 32gm Powder, 17.5ml Liquid (White)

Device Class :

Duns Number: 186285342

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

MASTER-DENT - 00816526021913 Catalog Number :

Device Description : EDTA Solution, 17% 2 oz bottle

Device Class :

Duns Number: 186285342

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

MASTER-DENT - 00816526021920 Catalog Number :

Device Description : EDTA Solution, 17% 8 oz bottle

Device Class :

Duns Number: 186285342

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

MASTER-DENT - 00816526021937 Catalog Number :

Device Description : Vinyl Polysiloxane Cartridges, Refill Kit , REGULAR Set, Monophase , 2 X 380 ml cartridge

Device Class :

Duns Number: 186285342

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

MASTER-DENT - 00816526021944 Catalog Number :

Device Description : Vinyl Polysiloxane Cartridges, Refill Kit , FAST Set, Monophase, 2 X 380 ml cartridge

Device Class :

Duns Number: 186285342

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

MASTER-DENT - 00816526021951 Catalog Number :

Device Description : Vinyl Polysiloxane Cartridges, REGULAR Set, Monophase , 1 X 380 ml cartridge, 1 Vinyl Polysiloxane Cartridges, REGULAR Set, Monophase , 1 X 380 ml cartridge, 1 Bayonet Ring, 10 Dynamic Mixing Tips

Device Class :

Duns Number: 186285342

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

MASTER-DENT - 00816526021968 Catalog Number :

Device Description : Vinyl Polysiloxane Cartridges, FAST Set, Monophase, 1 X 380 ml cartridge, 1 Bayo Vinyl Polysiloxane Cartridges, FAST Set, Monophase, 1 X 380 ml cartridge, 1 Bayonet Ring, 10 Dynamic Mixing Tips

Device Class :

Duns Number: 186285342

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

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