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 - 00883205003010 Catalog Number : 211119

Device Description : Luna Opal MB Mini .018 LL4 D/HK (-12°T +2°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003027 Catalog Number : 211120

Device Description : Luna Opal MB Mini .018 LR4 D/HK (-12°T +2°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003034 Catalog Number : 211121

Device Description : Luna Opal MB Mini .018 LL5 (-17°T +2°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003041 Catalog Number : 211122

Device Description : Luna Opal MB Mini .018 LR5 (-17°T +2°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003058 Catalog Number : 211123

Device Description : Luna Opal MB Mini .018 LL5 D/HK (-17°T +2°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003065 Catalog Number : 211124

Device Description : Luna Opal MB Mini .018 LR5 D/HK (-17°T +2°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003072 Catalog Number : 211201

Device Description : Luna Opal MB 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 - 00883205003089 Catalog Number : 211202

Device Description : Luna Opal MB 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 - 00883205003096 Catalog Number : 211203

Device Description : Luna Opal MB 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

Luna - 00883205003102 Catalog Number : 211204

Device Description : Luna Opal MB 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

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