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

Right-On Bonding Adhesives - 00192029000038 Catalog Number :

Device Description : RIGHT-ON SELF CURE BONDING, ONE SYRINGE WITH PASTE 4 g (.141 oz)

Device Class : 2

Duns Number: 005432299

Premarket Exempt : No

Product Code : DYH

Prescription Use : No

Device Count : 1

Right-On Bonding Adhesives - 00192029000045 Catalog Number :

Device Description : RIGHT-ON SELF CURE BONDING ADHESIVEKIT WITH 4 SYRINGES

Device Class : 2

Duns Number: 005432299

Premarket Exempt : No

Product Code : DYH

Prescription Use : No

Device Count : 1

Light Cure Adhesive - 00192029000052 Catalog Number :

Device Description : TURBO BOND II LIGHT CURE BONDING ADHESIVE KIT

Device Class : 2

Duns Number: 005432299

Premarket Exempt : No

Product Code : DYH

Prescription Use : No

Device Count : 1

Light Cure Adhesive - 00192029000069 Catalog Number :

Device Description : TURBO BOND II LIGHT CURE BONDING REPLACEMENT MATERIAL, Paste in Syringe, TURBO BOND II LIGHT CURE BONDING REPLACEMENT MATERIAL, Paste in Syringe, 4 g (.141 oz) Medium to Low Viscosity

Device Class : 2

Duns Number: 005432299

Premarket Exempt : No

Product Code : DYH

Prescription Use : No

Device Count : 1

Light Cure Adhesive - 00192029000083 Catalog Number :

Device Description : eXact CLEAR LIGHT CURE ADHESIVE KIT

Device Class : 2

Duns Number: 005432299

Premarket Exempt : No

Product Code : DYH

Prescription Use : No

Device Count : 1

Light Cure Adhesive - 00192029000090 Catalog Number :

Device Description : eXact CLEAR LIGHT ADHESIVE REPLACEMENT MATERIAL, Paste in 3 Syringes, 2 g (.071 oz) each

Device Class : 2

Duns Number: 005432299

Premarket Exempt : No

Product Code : DYH

Prescription Use : No

Device Count : 1

Light Cure Adhesive - 00192029000106 Catalog Number :

Device Description : eXact CLEAR LIGHT ADHESIVE REPLACEMENT MATERIAL , Paste in 1 Syringe, 2 g (.071 oz) each

Device Class : 2

Duns Number: 005432299

Premarket Exempt : No

Product Code : DYH

Prescription Use : No

Device Count : 1

Crosslink Bonding Adhesives - 00192029000113 Catalog Number :

Device Description : In Preloaded Syringe Natural 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 - 00192029000120 Catalog Number :

Device Description : Natural 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 - 00192029000137 Catalog Number :

Device Description : CROSSLINK SMALL PATIENT CAPLET, NATURAL COLOR CEMENT

Device Class : 2

Duns Number: 005432299

Premarket Exempt : No

Product Code : DYH

Prescription Use : No

Device Count : 1

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