ROYDENT DENTAL PRODUCTS INC

ROYDENT DENTAL 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

CROWN AND BRIDGE, TEMPORARY, RESIN (EBG) (4) CEMENT, DENTAL (EMA) (2) POINT, SILVER, ENDODONTIC (EKL) (2) RESIN, ROOT CANAL FILLING (KIF) (2)

Premarket Exempt

No

Clear

Roydent - D8091011 Catalog Number : 101

Device Description : C.L. CANAL LUBRICANT (150)

Device Class :

Duns Number: 131487225

Premarket Exempt : No

Product Code : EKL

Prescription Use : Yes

Device Count : 150

Roydent - D809102501R1 Catalog Number : 102501R

Device Description : 2Seal Easymix Syringe Refill

Device Class : 2

Duns Number: 131487225

Premarket Exempt : No

Product Code : KIF

Prescription Use : Yes

Device Count : 1

Roydent - D809102502R1 Catalog Number : 102502R

Device Description : 2Seal Easymix Tips Refill

Device Class :

Duns Number: 131487225

Premarket Exempt : No

Product Code : KIF

Prescription Use : Yes

Device Count : 40

Roydent - D8091031 Catalog Number : 103

Device Description : C.L. CANAL LUBRICANT (20 COUNT

Device Class :

Duns Number: 131487225

Premarket Exempt : No

Product Code : EKL

Prescription Use : Yes

Device Count : 20

Roydent - D809205STD1 Catalog Number : 205STD

Device Description : BOSTON POSTS CEMENT STD.

Device Class : 2

Duns Number: 131487225

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Roydent - D8095001 Catalog Number : 500

Device Description : REFORM TEMP. C&B MATERIAL A1

Device Class : 2

Duns Number: 131487225

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

Roydent - D8095011 Catalog Number : 501

Device Description : REFORM TEMP. C&B MATERIAL A2

Device Class : 2

Duns Number: 131487225

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

Roydent - D8095021 Catalog Number : 502

Device Description : REFORM TEMP. C&B MATERIAL A3.5

Device Class : 2

Duns Number: 131487225

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

Roydent - D8095031 Catalog Number : 503

Device Description : REFORM TEMP. C&B MATERIAL B1

Device Class : 2

Duns Number: 131487225

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

Roydent - D8097011 Catalog Number : 701

Device Description : CHEMLOCK CEMENT

Device Class : 2

Duns Number: 131487225

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

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