AMERICAN ORTHODONTICS CORPORATION

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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

Empower Clear - 00190746000300 Catalog Number : 1475-18-2302HD

Device Description : COSMETIC SL EMPOWER CLEAR INTERACT UL CUSPID 018 T-2 A+9 R=0 W/HK DIST

Device Class : 2

Duns Number: 044668515

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Empower Clear - 00190746000317 Catalog Number : 1475-18-2307

Device Description : COSMETIC SL EMPOWER CLEAR INTERACT UL CUSPID 018 T-7 A+8 R=0

Device Class : 2

Duns Number: 044668515

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Empower Clear - 00190746000324 Catalog Number : 1475-18-2307HD

Device Description : COSMETIC SL EMPOWER CLEAR INTERACT UL CUSPID 018 T-7 A+8 R=0 W/HK DIST

Device Class : 2

Duns Number: 044668515

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Empower Clear - 00190746000331 Catalog Number : 1475-18-2307HU

Device Description : COSMETIC SL EMPOWER CLEAR INTERACT UL CUSPID 018 T-7 A+8 R=0 W/HK UNV

Device Class : 2

Duns Number: 044668515

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Empower Clear - 00190746000348 Catalog Number : 1475-18-230HD

Device Description : COSMETIC SL EMPOWER CLEAR INTERACT UL CUSPID 018 T=0 A+8 R=0 W/HK DIST

Device Class : 2

Duns Number: 044668515

Premarket Exempt : No

Product Code : NJM

Prescription Use : No

Device Count : 1

Empower Clear - 00190746000355 Catalog Number : 1475-18-230HU

Device Description : COSMETIC SL EMPOWER CLEAR INTERACT UL CUSPID 018 T=0 A+8 R=0 W/HK UNV

Device Class : 2

Duns Number: 044668515

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Empower Clear - 00190746000362 Catalog Number : 1475-18-2407

Device Description : COSMETIC SL EMPOWER CLEAR INTERACT UL BICUSPID 018 T-7 A=0 R=0

Device Class : 2

Duns Number: 044668515

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Empower Clear - 00190746000379 Catalog Number : 1475-18-2407HD

Device Description : COSMETIC SL EMPOWER CLEAR INTERACT UL BICUSPID 018 T-7 A=0 R=0 W/HK DIST

Device Class : 2

Duns Number: 044668515

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Empower Clear - 00190746000386 Catalog Number : 1475-18-2407HU

Device Description : COSMETIC SL EMPOWER CLEAR INTERACT UL BICUSPID 018 T-7 A=0 R=0 W/HK UNV

Device Class : 2

Duns Number: 044668515

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Empower Clear - 00190746000393 Catalog Number : 1475-18-3101

Device Description : COSMETIC SL EMPOWER CLEAR INTERACT LL ANTERIOR 018 T-1 A=0 R=0

Device Class : 2

Duns Number: 044668515

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

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