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

Bracket, ceramic, orthodontic (NJM) (8) ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN (DYH) (2)

Premarket Exempt

No Yes

Clear

Bonding Accessories - 00192029000250 Catalog Number :

Device Description : Right-On Enamel Cond

Device Class : 2

Duns Number: 005432299

Premarket Exempt : Yes

Product Code : DYH

Prescription Use : No

Device Count : 1

Bonding Accessories - 00192029000267 Catalog Number :

Device Description : Porcelain Primer

Device Class : 2

Duns Number: 005432299

Premarket Exempt : Yes

Product Code : DYH

Prescription Use : No

Device Count : 1

InVu Ceramic Brackets - 00192029000304 Catalog Number :

Device Description : 022" ROTH WITHOUT JIGS

Device Class : 2

Duns Number: 005432299

Premarket Exempt : No

Product Code : NJM

Prescription Use : No

Device Count : 1

Ceramic/Metal Combination Kits - 00192029000311 Catalog Number :

Device Description : 0.46mm (.018") Upper 3-3 InVu Ceramic Brackets

Device Class : 2

Duns Number: 005432299

Premarket Exempt : No

Product Code : NJM

Prescription Use : No

Device Count : 1

Ceramic/Metal Combination Kits - 00192029000328 Catalog Number :

Device Description : 0.56mm (.022") Upper 3-3 InVu Ceramic Brackets

Device Class : 2

Duns Number: 005432299

Premarket Exempt : No

Product Code : NJM

Prescription Use : No

Device Count : 1

Ceramic/Metal Combination Kits - 00192029000335 Catalog Number :

Device Description : 0.46mm (.018") Upper 5-5 InVu Ceramic Brackets

Device Class : 2

Duns Number: 005432299

Premarket Exempt : No

Product Code : NJM

Prescription Use : No

Device Count : 1

ClearVu Mini Ceramic Brackets - 00192029000342 Catalog Number :

Device Description : Upper 5-5 Cuspid/Bicuspid W/Hook Clear VuÌ« Mini Ceramic All Remaining Brackets Upper 5-5 Cuspid/Bicuspid W/Hook Clear VuÌ« Mini Ceramic All Remaining Brackets Lower 5-5 Nu-EdgeÌ« Metal 0.46 mm (.018") Bondable

Device Class : 2

Duns Number: 005432299

Premarket Exempt : No

Product Code : NJM

Prescription Use : No

Device Count : 1

Ceramic/Metal Combination Kits - 00192029000359 Catalog Number :

Device Description : 0.56mm (.022") Upper 5-5 InVu Ceramic Brackets

Device Class : 2

Duns Number: 005432299

Premarket Exempt : No

Product Code : NJM

Prescription Use : No

Device Count : 1

Ceramic/Metal Combination Kits - 00192029000366 Catalog Number :

Device Description : 0.46mm (.018)" Upper 4-4 & Lower 3-3 InVu Ceramic Brackets W/Cuspid Hook

Device Class : 2

Duns Number: 005432299

Premarket Exempt : No

Product Code : NJM

Prescription Use : No

Device Count : 1

ClearVu Mini Ceramic Brackets - 00192029000373 Catalog Number :

Device Class : 2

Duns Number: 005432299

Premarket Exempt : No

Product Code : NJM

Prescription Use : No

Device Count : 1

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