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 - 00190746000409 Catalog Number : 1475-18-3106

Device Description : COSMETIC SL EMPOWER CLEAR INTERACT LL ANTERIOR 018 T-6 A=0 R=0

Device Class : 2

Duns Number: 044668515

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Empower Clear - 00190746000416 Catalog Number : 1475-18-3306HD

Device Description : COSMETIC SL EMPOWER CLEAR INTERACT LL CUSPID 018 T-6 A+3 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 - 00190746000423 Catalog Number : 1475-18-330HD

Device Description : COSMETIC SL EMPOWER CLEAR INTERACT LL CUSPID 018 T=0 A+3 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 - 00190746000430 Catalog Number : 1475-18-3311HD

Device Description : COSMETIC SL EMPOWER CLEAR INTERACT LL CUSPID 018 T-11 A+7 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 - 00190746000447 Catalog Number : 1475-18-3412

Device Description : COSMETIC SL EMPOWER CLEAR INTERACT LL 1ST BICUSPID 018 T-12 A+2 R=0

Device Class : 2

Duns Number: 044668515

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Empower Clear - 00190746000454 Catalog Number : 1475-18-3412HD

Device Description : COSMETIC SL EMPOWER CLEAR INTERACT LL 1ST BICUSPID 018 T-12 A+2 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 - 00190746000461 Catalog Number : 1475-18-3417

Device Description : COSMETIC SL EMPOWER CLEAR INTERACT LL 1ST BICUSPID 018 T-17 A=0 R=0

Device Class : 2

Duns Number: 044668515

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Empower Clear - 00190746000478 Catalog Number : 1475-18-3417HD

Device Description : COSMETIC SL EMPOWER CLEAR INTERACT LL 1ST BICUSPID 018 T-17 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 - 00190746000485 Catalog Number : 1475-18-3517

Device Description : COSMETIC SL EMPOWER CLEAR INTERACT LL 2ND BICUSPID 018 T-17 A+2 R=0

Device Class : 2

Duns Number: 044668515

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Empower Clear - 00190746000492 Catalog Number : 1475-18-3517HD

Device Description : COSMETIC SL EMPOWER CLEAR INTERACT LL 2ND BICUSPID 018 T-17 A+2 R=0 W/HK DIST

Device Class : 2

Duns Number: 044668515

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

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