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 - 00190746000201 Catalog Number : 1475-18-130HD

Device Description : COSMETIC SL EMPOWER CLEAR INTERACT UR 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 : Yes

Device Count : 1

Empower Clear - 00190746000218 Catalog Number : 1475-18-130HU

Device Description : COSMETIC SL EMPOWER CLEAR INTERACT UR 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 - 00190746000225 Catalog Number : 1475-18-1407

Device Description : COSMETIC SL EMPOWER CLEAR INTERACT UR 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 - 00190746000232 Catalog Number : 1475-18-1407HD

Device Description : COSMETIC SL EMPOWER CLEAR INTERACT UR 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 - 00190746000249 Catalog Number : 1475-18-1407HU

Device Description : COSMETIC SL EMPOWER CLEAR INTERACT UR 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 - 00190746000256 Catalog Number : 1475-18-2112

Device Description : COSMETIC SL EMPOWER CLEAR INTERACT UL CENTRAL 018 T+12 A+5 R=0

Device Class : 2

Duns Number: 044668515

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Empower Clear - 00190746000263 Catalog Number : 1475-18-2117

Device Description : COSMETIC SL EMPOWER CLEAR INTERACT UL CENTRAL 018 T+17 A+4 R=0

Device Class : 2

Duns Number: 044668515

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Empower Clear - 00190746000270 Catalog Number : 1475-18-2210

Device Description : COSMETIC SL EMPOWER CLEAR INTERACT UL LATERAL 018 T+10 A+8 R=0

Device Class : 2

Duns Number: 044668515

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Empower Clear - 00190746000287 Catalog Number : 1475-18-228

Device Description : COSMETIC SL EMPOWER CLEAR INTERACT UL LATERAL 018 T+8 A+9 R=0

Device Class : 2

Duns Number: 044668515

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Empower Clear - 00190746000294 Catalog Number : 1475-18-230

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

Device Class : 2

Duns Number: 044668515

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

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