AccessGUDID - DEVICE: Therma Cure (D798TC0)

GUDID

Device Identifier (DI) Information

Brand Name: Therma Cure
Version or Model: TC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TC
Company Name: RELIANCE ORTHODONTIC PRODUCTS INC

Primary DI Number: D798TC0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 113170088 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
16737	Denture base resin kit, heat-cured	A collection of resins and other devices and/or materials intended to be used in the dental laboratory to manufacture a complete or partial denture base (the portion of a denture that rests on the oral mucosa and retains the artificial teeth) using resins that polymerize with heat. It usually includes the resin monomer (typically an acrylic monomer of methyl methacrylate) and a catalyst intended for polymerization of the monomer; it also includes other products such as pigments, plasticizers, and/or devices (e.g., flasks, clamps). This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DYH	Adhesive, Bracket And Tooth Conditioner, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K071590	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store at room temperature (15-30 degrees C.)

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 628418d7-a604-4fed-b30d-4516cee77b4f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 27, 2016