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 - 00883205002914 Catalog Number : 211109

Device Description : Luna Opal MB 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 - 00883205002921 Catalog Number : 211110

Device Description : Luna Opal MB 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 - 00883205002938 Catalog Number : 211111

Device Description : Luna Opal MB 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 - 00883205002945 Catalog Number : 211112

Device Description : Luna Opal MB Mini .018 LA1,2 (-6°T 0°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205002952 Catalog Number : 211113

Device Description : Luna Opal MB Mini .018 LL3 (-6°T +3°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205002969 Catalog Number : 211114

Device Description : Luna Opal MB Mini .018 LR3 (-6°T +3°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205002976 Catalog Number : 211115

Device Description : Luna Opal MB Mini .018 LL3 D/HK (-6°T +3°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205002983 Catalog Number : 211116

Device Description : Luna Opal MB Mini .018 LR3 D/HK (-6°T +3°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205002990 Catalog Number : 211117

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

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Luna - 00883205003003 Catalog Number : 211118

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

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

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