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) (6) CORD, RETRACTION (MVL) (4)

Premarket Exempt

No Yes

Clear

Luna - 00883205003416 Catalog Number : 211404

Device Description : Luna Opal R Mini .018 Kit 5x5 U & L Hooks 3, 4, 5

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003423 Catalog Number : 211405

Device Description : Luna Opal R Mini .018 Kit 3x3 U

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003430 Catalog Number : 211406

Device Description : Luna Opal R Mini .018 Kit 5x5 U

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003447 Catalog Number : 211407

Device Description : Luna Opal R Mini .018 Kit 3x3 U Hooks

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003454 Catalog Number : 211408

Device Description : Luna Opal R Mini .018 Kit 5x5 U Hooks 3

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003461 Catalog Number : 211409

Device Description : Luna Opal R Mini .018 Kit 5x5 U Hooks 3, 4, 5

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Ultrapak E - 00883205003713 Catalog Number : 200

Device Description : Ultrapak E #2

Device Class : U

Duns Number: 013369913

Premarket Exempt : No

Product Code : MVL

Prescription Use : Yes

Device Count : 1

Ultrapak E - 00883205003720 Catalog Number : 199

Device Description : Ultrapak E #1

Device Class : U

Duns Number: 013369913

Premarket Exempt : No

Product Code : MVL

Prescription Use : Yes

Device Count : 1

Ultrapak E - 00883205003737 Catalog Number : 198

Device Description : Ultrapak E #0

Device Class : U

Duns Number: 013369913

Premarket Exempt : No

Product Code : MVL

Prescription Use : Yes

Device Count : 1

Ultrapak E - 00883205003744 Catalog Number : 197

Device Description : Ultrapak E #00

Device Class : U

Duns Number: 013369913

Premarket Exempt : No

Product Code : MVL

Prescription Use : Yes

Device Count : 1

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