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

ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN (DYH) (10)

Premarket Exempt

No Yes

Clear

Crosslink Bonding Adhesives - 00192029000144 Catalog Number :

Device Description : CROSSLINK SMALL PATIENT CAPLT, BLUE COLOR CEMENT

Device Class : 2

Duns Number: 005432299

Premarket Exempt : No

Product Code : DYH

Prescription Use : No

Device Count : 1

Crosslink Bonding Adhesives - 00192029000151 Catalog Number :

Device Description : Blue Color Paste 24 g (.847 oz)

Device Class : 2

Duns Number: 005432299

Premarket Exempt : No

Product Code : DYH

Prescription Use : No

Device Count : 1

Crosslink Bonding Adhesives - 00192029000168 Catalog Number :

Device Description : Blue Color Paste in Syringe 4 g (.141 oz)

Device Class : 2

Duns Number: 005432299

Premarket Exempt : No

Product Code : DYH

Prescription Use : No

Device Count : 1

Crosslink Bonding Adhesives - 00192029000175 Catalog Number :

Device Description : Crosslink Single Patient Caplets

Device Class : 2

Duns Number: 005432299

Premarket Exempt : No

Product Code : DYH

Prescription Use : No

Device Count : 1

Crosslink Bonding Adhesives - 00192029000182 Catalog Number :

Device Description : Crosslink Single Patient Caplets

Device Class : 2

Duns Number: 005432299

Premarket Exempt : No

Product Code : DYH

Prescription Use : No

Device Count : 1

Light Cure Adhesive - 00192029000199 Catalog Number :

Device Description : Light Cure Sealant

Device Class : 2

Duns Number: 005432299

Premarket Exempt : Yes

Product Code : DYH

Prescription Use : No

Device Count : 1

Bonding Accessories - 00192029000205 Catalog Number :

Device Description : Enamel Conditioner G

Device Class : 2

Duns Number: 005432299

Premarket Exempt : Yes

Product Code : DYH

Prescription Use : No

Device Count : 1

Bonding Accessories - 00192029000212 Catalog Number :

Device Description : Enamel Conditioner S

Device Class : 2

Duns Number: 005432299

Premarket Exempt : Yes

Product Code : DYH

Prescription Use : No

Device Count : 1

Bonding Accessories - 00192029000236 Catalog Number :

Device Description : TPO Blue Etchant Gel

Device Class : 2

Duns Number: 005432299

Premarket Exempt : Yes

Product Code : DYH

Prescription Use : No

Device Count : 1

Bonding Accessories - 00192029000243 Catalog Number :

Device Description : TPO Blue Etchant Gel

Device Class : 2

Duns Number: 005432299

Premarket Exempt : Yes

Product Code : DYH

Prescription Use : No

Device Count : 1

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