3M UNITEK CORPORATION

Address:2724 SOUTH PECK RD.,MONROVIA,CA,91016,US

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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

Clarity™ SL - 00652221004154 Catalog Number : 007-412

Device Description : Clarity(TM) SL Self-Ligating Bracket MBT(TM) UR3 0T/8A .022 5/Pk

Device Class :

Duns Number: 008256356

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Clarity™ SL - 00652221004208 Catalog Number : 007-417

Device Description : Clarity(TM) SL Self-Ligating Bracket Roth UL1 12T/5A .022 5/Pk

Device Class :

Duns Number: 008256356

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Clarity™ SL - 00652221004215 Catalog Number : 007-418

Device Description : Clarity(TM) SL Self-Ligating Bracket Roth UR1 12T/5A .022 5/Pk

Device Class :

Duns Number: 008256356

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Clarity™ SL - 00652221004222 Catalog Number : 007-419

Device Description : Clarity(TM) SL Self-Ligating Bracket Roth UL2 8T/9A .022 5/Pk

Device Class :

Duns Number: 008256356

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Clarity™ SL - 00652221004239 Catalog Number : 007-420

Device Description : Clarity(TM) SL Self-Ligating Bracket Roth UR2 8T/9A .022 5/Pk

Device Class :

Duns Number: 008256356

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Clarity™ SL - 00652221004246 Catalog Number : 007-421

Device Description : Clarity(TM) SL Self-Ligating Bracket Roth UL3 -2T/9A Hk .022 5/Pk

Device Class :

Duns Number: 008256356

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Clarity™ SL - 00652221004253 Catalog Number : 007-422

Device Description : Clarity(TM) SL Self-Ligating Bracket Roth UR3 -2T/9A Hk .022 5/Pk

Device Class :

Duns Number: 008256356

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Clarity™ SL - 00652221004260 Catalog Number : 007-423

Device Description : Clarity(TM) SL Self-Ligating Bracket Roth UL4,5 -7T/0A Hk .022 5/Pk

Device Class :

Duns Number: 008256356

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Clarity™ SL - 00652221004277 Catalog Number : 007-424

Device Description : Clarity(TM) SL Self-Ligating Bracket Roth UR4,5 -7T/0A Hk .022 5/Pk

Device Class :

Duns Number: 008256356

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Clarity™ SL - 00652221004314 Catalog Number : 007-501

Device Description : Clarity(TM) SL Self-Ligating Bracket MBT(TM) UL1 17T/4A .018 5/Pk

Device Class :

Duns Number: 008256356

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

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