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 - 00883205003119 Catalog Number : 211205

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

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003126 Catalog Number : 211206

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

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003133 Catalog Number : 211207

Device Description : Luna Opal MB 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 - 00883205003140 Catalog Number : 211208

Device Description : Luna Opal MB 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 - 00883205003157 Catalog Number : 211209

Device Description : Luna Opal MB 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

Luna - 00883205003164 Catalog Number : 211301

Device Description : Luna Opal R Mini .018 UL1 (+12°T +5°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003171 Catalog Number : 211302

Device Description : Luna Opal R Mini .018 UR1 (+12°T +5°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003188 Catalog Number : 211303

Device Description : Luna Opal R Mini .018 UL2 (+8°T +9°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003195 Catalog Number : 211304

Device Description : Luna Opal R Mini .018 UR2 (+8°T +9°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003201 Catalog Number : 211305

Device Description : Luna Opal R Mini .018 UL3 (0°T +11°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

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