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) (6) ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN (DYH) (2) Bracket, Ceramic, Orthodontic (NJM) (1) Bracket, Metal, Orthodontic (EJF) (1)

Premarket Exempt

No Yes

Clear

Empower Clear - 00190746000003 Catalog Number : 1585-22-1407HD

Device Description : COSMETIC SL EMPOWER CLEAR PASSIVE UR BICUSPID 022 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

Eagle Spectrum - 00190746000010 Catalog Number : 001-945

Device Description : EAGLE SPECTRUM LIGHT CURE CARPULE KIT

Device Class : 2

Duns Number: 044668515

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

Eagle No Drift - 00190746000027 Catalog Number : 001-948

Device Description : EAGLE NO DRIFT ADHESIVE CARPULE KIT

Device Class : 2

Duns Number: 044668515

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

Empower2 - 00190746000034 Catalog Number : 475-1112

Device Description : DB BKT SL EMPOWER INTERACT UR CENTRAL 018 T+12 A+5 R=0

Device Class : 1

Duns Number: 044668515

Premarket Exempt : Yes

Product Code : EJF

Prescription Use : Yes

Device Count : 1

Empower Clear - 00190746000041 Catalog Number : 1585-22-1407

Device Description : COSMETIC SL EMPOWER CLEAR PASSIVE UR BICUSPID 022 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 - 00190746000058 Catalog Number : 1585-22-2407HD

Device Description : COSMETIC SL EMPOWER CLEAR PASSIVE UL BICUSPID 022 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 - 00190746000065 Catalog Number : 1585-22-130HD

Device Description : COSMETIC SL EMPOWER CLEAR PASSIVE UR CUSPID 022 T=0 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 - 00190746000072 Catalog Number : 1585-22-230HD

Device Description : COSMETIC SL EMPOWER CLEAR PASSIVE UL CUSPID 022 T=0 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 - 00190746000089 Catalog Number : 1585-22-430HD

Device Description : COSMETIC SL EMPOWER CLEAR PASSIVE LR CUSPID 022 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 - 00190746000096 Catalog Number : 1585-22-330HD

Device Description : COSMETIC SL EMPOWER CLEAR PASSIVE LL CUSPID 022 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

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