AccessGUDID - DEVICE: TEMREX SATIN POLISHING PASTE (00850015110474)

GUDID

Device Identifier (DI) Information

Brand Name: TEMREX SATIN POLISHING PASTE
Version or Model: 5200, 5210
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TEMREX CORPORATION

Primary DI Number: 00850015110474
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012072823 *Terms of Use

Device Description: For restoring the original smoothness and polishing of dental porcelain crowns, inlays, onlays, veneers and bridges; for both intra and extra oral use.

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):	No
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?
11168	Dentifrice	A substance, or combination of substances, intended to be used for cleaning the accessible surfaces of the teeth by polishing. It typically includes mild abrasives, detergents, flavouring agents, and other products, and is normally supplied as a toothpaste or tooth powder intended for self-application using a toothbrush, or formulated to be applied by dental professionals using a handpiece attachment. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJR	Agent, Polishing, Abrasive, Oral Cavity

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K852157	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fd94fb4d-1e36-40f5-8e5c-33f27ca93deb
Public Version Date: March 17, 2022
Public Version Number: 1
DI Record Publish Date: March 09, 2022