ULTRADENT 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

RETAINER, MATRIX (JEP) (2) ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION (EBZ) (1)

Premarket Exempt

No Yes

Clear

Omni-Matrix - 00883205108821 Catalog Number : 2203

Device Description : Omni-Matrix Winged Mylar (Red) Refill

Device Class : 1

Duns Number: 013369913

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 1

Omni-Matrix - 00883205108838 Catalog Number : 2204

Device Description : Omni-Matrix Winged Pedo (Purple) Refill

Device Class : 1

Duns Number: 013369913

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 1

VALO - 00883205110275 Catalog Number : 5971-

Device Description : VALO GRAND Corded Curing Light

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : EBZ

Prescription Use : Yes

Device Count : 1

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