TP ORTHODONTICS INC

Address:100 CENTER PLAZA,LA PORTE,IN,46350,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

DEPRESSOR, TONGUE, NON-SURGICAL (FMA) (6) BUR, DENTAL (EJL) (3) BAND, PREFORMED, ORTHODONTIC (ECM) (1)

Premarket Exempt

Yes No

Clear

1st Molar Grip-Tite Standard Band - 00192029049297 Catalog Number :

Device Description : BAND ORDER

Device Class : 1

Duns Number: 005432299

Premarket Exempt : Yes

Product Code : ECM

Prescription Use : No

Device Count : 1

Carbide - 00192029049358 Catalog Number :

Device Description : Debonding Bur

Device Class : 1

Duns Number: 005432299

Premarket Exempt : Yes

Product Code : EJL

Prescription Use : No

Device Count : 1

Carbide - 00192029049365 Catalog Number :

Device Description : Debonding Bur

Device Class : 1

Duns Number: 005432299

Premarket Exempt : Yes

Product Code : EJL

Prescription Use : No

Device Count : 1

Carbide - 00192029049372 Catalog Number :

Device Description : Debonding Bur

Device Class : 1

Duns Number: 005432299

Premarket Exempt : Yes

Product Code : EJL

Prescription Use : No

Device Count : 1

Tongue-Away Sheild - 00192029049396 Catalog Number :

Device Description : Medium

Device Class : 1

Duns Number: 005432299

Premarket Exempt : Yes

Product Code : FMA

Prescription Use : No

Device Count : 1

Tongue-Away Sheild - 00192029049402 Catalog Number :

Device Description : Medium

Device Class : 1

Duns Number: 005432299

Premarket Exempt : Yes

Product Code : FMA

Prescription Use : No

Device Count : 1

Tongue-Away Sheild - 00192029049419 Catalog Number :

Device Description : Medium

Device Class : 1

Duns Number: 005432299

Premarket Exempt : Yes

Product Code : FMA

Prescription Use : No

Device Count : 1

Tongue-Away Sheild - 00192029049426 Catalog Number :

Device Description : Medium

Device Class : 1

Duns Number: 005432299

Premarket Exempt : Yes

Product Code : FMA

Prescription Use : No

Device Count : 1

Tongue-Away Sheild - 00192029049433 Catalog Number :

Device Description : Small

Device Class : 1

Duns Number: 005432299

Premarket Exempt : Yes

Product Code : FMA

Prescription Use : No

Device Count : 1

Tongue-Away Sheild - 00192029049440 Catalog Number :

Device Description : Medium

Device Class : 1

Duns Number: 005432299

Premarket Exempt : Yes

Product Code : FMA

Prescription Use : No

Device Count : 1

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