Bonding Accessories

GUDID 00192029000205

Enamel Conditioner G

TP ORTHODONTICS INC

Orthodontic bracket adhesive
Primary Device ID00192029000205
NIH Device Record Keyccef4f58-27aa-4056-9067-919de119ed1a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBonding Accessories
Version Model Number150-015
Company DUNS005432299
Company NameTP ORTHODONTICS INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(219)785-2591
Emailnicholas.smith@tportho.com
Phone+1(219)785-2591
Emailnicholas.smith@tportho.com
Phone+1(219)785-2591
Emailnicholas.smith@tportho.com
Phone+1(219)785-2591
Emailnicholas.smith@tportho.com
Phone+1(219)785-2591
Emailnicholas.smith@tportho.com
Phone+1(219)785-2591
Emailnicholas.smith@tportho.com
Phone+1(219)785-2591
Emailnicholas.smith@tportho.com
Phone+1(219)785-2591
Emailnicholas.smith@tportho.com
Phone+1(219)785-2591
Emailnicholas.smith@tportho.com
Phone+1(219)785-2591
Emailnicholas.smith@tportho.com
Phone+1(219)785-2591
Emailnicholas.smith@tportho.com
Phone+1(219)785-2591
Emailnicholas.smith@tportho.com
Phone+1(219)785-2591
Emailnicholas.smith@tportho.com
Phone+1(219)785-2591
Emailnicholas.smith@tportho.com
Phone+1(219)785-2591
Emailnicholas.smith@tportho.com
Phone+1(219)785-2591
Emailnicholas.smith@tportho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100192029000205 [Primary]

FDA Product Code

DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-09
Device Publish Date2022-02-01

On-Brand Devices [Bonding Accessories]

00192029000267Porcelain Primer
00192029000250Right-On Enamel Cond
00192029000243TPO Blue Etchant Gel
00192029000236TPO Blue Etchant Gel
00192029000212Enamel Conditioner S
00192029000205Enamel Conditioner G
00192029043288ADHESIVE, BRACKET-Tooth Conditioner, Resin
00192029043271ADHESIVE, BRACKET-Tooth Conditioner, Resin

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