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 - 00883205003218 Catalog Number : 211306

Device Description : Luna Opal R Mini .018 UR3 (0°T +11°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003225 Catalog Number : 211307

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

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003232 Catalog Number : 211308

Device Description : Luna Opal R Mini .018 UR3 D/HK (0°T +11°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003249 Catalog Number : 211309

Device Description : Luna Opal R Mini .018 UU4,5 (-7°T 0°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003256 Catalog Number : 211310

Device Description : Luna Opal R Mini .018 UL4,5 D/HK (-7°T 0°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003263 Catalog Number : 211311

Device Description : Luna Opal R Mini .018 UR4,5 D/HK (-7°T 0°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003270 Catalog Number : 211312

Device Description : Luna Opal R Mini .018 LA1,2 (0°T 0°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003287 Catalog Number : 211313

Device Description : Luna Opal R Mini .018 LL3 (-11°T +5°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003294 Catalog Number : 211314

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

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003300 Catalog Number : 211315

Device Description : Luna Opal R Mini .018 LL3 D/HK (-11°T +5°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

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