ULTRADENT PRODUCTS, INC.

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

Bracket, ceramic, orthodontic (NJM) (8) ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION (EBZ) (1) SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING (EIC) (1)

Premarket Exempt

No Yes

Clear

Opal-Etch - 00883205000019 Catalog Number : 1863

Device Description : Opal Ortho Empty Syringe 1.2ml 20pk

Device Class : 1

Duns Number: 013369913

Premarket Exempt : Yes

Product Code : EIC

Prescription Use : Yes

Device Count : 1

VALO - 00883205000026 Catalog Number : 5964-

Device Description : VALO Cordless 500 Barrier Sleeves Refill

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : EBZ

Prescription Use : Yes

Device Count : 1

Luna - 00883205002839 Catalog Number : 211101

Device Description : Luna Opal MB Mini .018 UL1 (+17°T +4°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205002846 Catalog Number : 211102

Device Description : Luna Opal MB Mini .018 UR1 (+17°T +4°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205002853 Catalog Number : 211103

Device Description : Luna Opal MB Mini .018 UL2 (+10°T +8°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205002860 Catalog Number : 211104

Device Description : Luna Opal MB Mini .018 UR2 (+10°T +8°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205002877 Catalog Number : 211105

Device Description : Luna Opal MB Mini .018 UL3 (-7°T +8°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205002884 Catalog Number : 211106

Device Description : Luna Opal MB Mini .018 UR3 (-7°T +8°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205002891 Catalog Number : 211107

Device Description : Luna Opal MB Mini .018 UL3 D/HK (-7°T +8°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205002907 Catalog Number : 211108

Device Description : Luna Opal MB Mini .018 UR3 D/HK (-7°T +8°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

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