IVOCLAR VIVADENT, INC.

Address:1-6600 Dixie Road,Mississauga Ontario,CA

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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

Alloy, gold-based noble metal (EJT) (6) ALLOY, OTHER NOBLE METAL (EJS) (4)

Premarket Exempt

No Yes

Clear

Laser Ceramic White - D707NA11951040 Catalog Number : NA1195104

Device Description : Laser Ceramic White .3mm Spool

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJT

Prescription Use : Yes

Device Count : 1

Laser Ceramic Yellow - D707NA11952040 Catalog Number : NA1195204

Device Description : Laser Ceramic Yellow .3mm Spool

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJT

Prescription Use : Yes

Device Count : 1

Laser Ceramic Yellow PdF - D707NA11953040 Catalog Number : NA1195304

Device Description : Laser Ceramic Yellow PdF .3mm Spool

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJT

Prescription Use : Yes

Device Count : 1

Laser C B White - D707NA11954040 Catalog Number : NA1195404

Device Description : Laser C&B White .3mm Spool

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJS

Prescription Use : Yes

Device Count : 1

Laser C B Yellow - D707NA11955040 Catalog Number : NA1195504

Device Description : Laser C&B Yellow .3mm Spool

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJS

Prescription Use : Yes

Device Count : 1

Laser Ceramic White - D707NA11956040 Catalog Number : NA1195604

Device Description : Laser Ceramic White .5mm Spool

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJT

Prescription Use : Yes

Device Count : 1

Laser Ceramic Yellow - D707NA11957040 Catalog Number : NA1195704

Device Description : Laser Ceramic Yellow .5mm Spool

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJT

Prescription Use : Yes

Device Count : 1

Laser Ceramic Yellow PdF - D707NA11958040 Catalog Number : NA1195804

Device Description : Laser Ceramic Yellow PdF .5mm Spool

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJT

Prescription Use : Yes

Device Count : 1

Laser C B White - D707NA11959040 Catalog Number : NA1195904

Device Description : Laser C&B White .5mm Spool

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJS

Prescription Use : Yes

Device Count : 1

Laser C B Yellow - D707NA11960040 Catalog Number : NA1196004

Device Description : Laser C&B Yellow .5mm Spool

Device Class : 2

Duns Number: 176935203

Premarket Exempt : Yes

Product Code : EJS

Prescription Use : Yes

Device Count : 1

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