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 - 00652221004321 Catalog Number : 007-502

Device Description : Clarity(TM) SL Self-Ligating Bracket MBT(TM) UR1 17T/4A .018 5/Pk

Device Class :

Duns Number: 008256356

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Clarity™ SL - 00652221004338 Catalog Number : 007-503

Device Description : Clarity(TM) SL Self-Ligating Bracket MBT(TM) UL2 10T/8A .018 5/Pk

Device Class :

Duns Number: 008256356

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Clarity™ SL - 00652221004345 Catalog Number : 007-504

Device Description : Clarity(TM) SL Self-Ligating Bracket MBT(TM) UR2 10T/8A .018 5/Pk

Device Class :

Duns Number: 008256356

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Clarity™ SL - 00652221004352 Catalog Number : 007-505

Device Description : Clarity(TM) SL Self-Ligating Bracket MBT(TM) UL3 0T/8A Hk .018 5/Pk

Device Class :

Duns Number: 008256356

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Clarity™ SL - 00652221004369 Catalog Number : 007-506

Device Description : Clarity(TM) SL Self-Ligating Bracket MBT(TM) UR3 0T/8A Hk .018 5/Pk

Device Class :

Duns Number: 008256356

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Clarity™ SL - 00652221004376 Catalog Number : 007-507

Device Description : Clarity(TM) SL Self-Ligating Bracket MBT(TM) UL4,5 -7T/0A Hk .018 5/Pk

Device Class :

Duns Number: 008256356

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Clarity™ SL - 00652221004383 Catalog Number : 007-508

Device Description : Clarity(TM) SL Self-Ligating Bracket MBT(TM) UR4,5 -7T/0A Hk .018 5/Pk

Device Class :

Duns Number: 008256356

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Clarity™ SL - 00652221004390 Catalog Number : 007-509

Device Description : Clarity(TM) SL Self-Ligating Bracket MBT(TM)/Roth U4,5 -7T/0A .018 5/Pk

Device Class :

Duns Number: 008256356

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Clarity™ SL - 00652221004406 Catalog Number : 007-511

Device Description : Clarity(TM) SL Self-Ligating Bracket MBT(TM) UL3 0T/8A .018 5/Pk

Device Class :

Duns Number: 008256356

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Clarity™ SL - 00652221004413 Catalog Number : 007-512

Device Description : Clarity(TM) SL Self-Ligating Bracket MBT(TM) UR3 0T/8A .018 5/Pk

Device Class :

Duns Number: 008256356

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

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