Therma Cure TC

GUDID D798TC0

Therma-Cure is intended for use as a heat curable adhesive for indirect bonding.

RELIANCE ORTHODONTIC PRODUCTS INC

Denture base resin kit, heat-cured Denture base resin kit, heat-cured
Primary Device IDD798TC0
NIH Device Record Key628418d7-a604-4fed-b30d-4516cee77b4f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTherma Cure
Version Model NumberTC
Catalog NumberTC
Company DUNS113170088
Company NameRELIANCE ORTHODONTIC PRODUCTS INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone630-773-4009
Emailpaulgropi@aol.com
Phone630-773-4009
Emailpaulgropi@aol.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 degrees C.)
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 degrees C.)

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD798TC0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYHAdhesive, Bracket And Tooth Conditioner, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-27

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