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) (10)

Premarket Exempt

No Yes

Clear

Luna - 00883205003317 Catalog Number : 211316

Device Description : Luna Opal R Mini .018 LR3 D/HK (-11°T +5°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003324 Catalog Number : 211317

Device Description : Luna Opal R Mini .018 LU4 (-17°T 0°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003331 Catalog Number : 211318

Device Description : Luna Opal R Mini .018 LL4 D/HK (-17°T 0°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003348 Catalog Number : 211319

Device Description : Luna Opal R Mini .018 LR4 D/HK (-17°T 0°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003355 Catalog Number : 211320

Device Description : Luna Opal R Mini .018 LU5 (-22°T 0°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003362 Catalog Number : 211321

Device Description : Luna Opal R Mini .018 LL5 D/HK (-22°T 0°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003379 Catalog Number : 211322

Device Description : Luna Opal R Mini .018 LR5 D/HK (-22°T 0°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003386 Catalog Number : 211401

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

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003393 Catalog Number : 211402

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

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003409 Catalog Number : 211403

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

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

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