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

SPRING, ORTHODONTIC (ECO) (4) APPLICATOR, RESIN (KXR) (2) DEPRESSOR, TONGUE, NON-SURGICAL (FMA) (2) BRACKET, METAL, ORTHODONTIC (EJF) (1) WAX, DENTAL, INTRAORAL (EGD) (1)

Premarket Exempt

No Yes

Clear

Tongue-Away Sheild - 00192029049457 Catalog Number :

Device Description : Small, Medium, Large

Device Class : 1

Duns Number: 005432299

Premarket Exempt : Yes

Product Code : FMA

Prescription Use : No

Device Count : 1

Mor-Tight - 00192029049464 Catalog Number :

Device Description : Store In Cool Dry Place

Device Class : 1

Duns Number: 005432299

Premarket Exempt : Yes

Product Code : EGD

Prescription Use : No

Device Count : 1

Tongue-Away Sheild - 00192029049471 Catalog Number :

Device Description : Shield

Device Class : 1

Duns Number: 005432299

Premarket Exempt : Yes

Product Code : FMA

Prescription Use : No

Device Count : 1

Disposable Brushes - 00192029049563 Catalog Number :

Device Description : Brush

Device Class : 1

Duns Number: 005432299

Premarket Exempt : Yes

Product Code : KXR

Prescription Use : No

Device Count : 1

Adhesive Plastic Applicators - 00192029049570 Catalog Number :

Device Description : Applicator

Device Class : 1

Duns Number: 005432299

Premarket Exempt : Yes

Product Code : KXR

Prescription Use : No

Device Count : 1

Begg Spring-Pin - 00192029049587 Catalog Number :

Device Description : CW Stainless Steel

Device Class : 1

Duns Number: 005432299

Premarket Exempt : Yes

Product Code : ECO

Prescription Use : No

Device Count : 1

Bicuspid Laminated Mesh - 00192029049594 Catalog Number :

Device Description : Bonding Base

Device Class : 1

Duns Number: 005432299

Premarket Exempt : Yes

Product Code : EJF

Prescription Use : No

Device Count : 1

Begg Rotating Springs - 00192029049600 Catalog Number :

Device Description : CCW Medium

Device Class : 1

Duns Number: 005432299

Premarket Exempt : Yes

Product Code : ECO

Prescription Use : No

Device Count : 1

Begg Rotating Springs - 00192029049617 Catalog Number :

Device Description : CW Medium

Device Class : 1

Duns Number: 005432299

Premarket Exempt : Yes

Product Code : ECO

Prescription Use : No

Device Count : 1

Ball-End Seating Springs - 00192029049624 Catalog Number :

Device Description : Large

Device Class : 1

Duns Number: 005432299

Premarket Exempt : Yes

Product Code : ECO

Prescription Use : No

Device Count : 1

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