AccessGUDID - DEVICE: MODIFYING STAIN (D772ATI600400P0)

GUDID

Device Identifier (DI) Information

Brand Name: MODIFYING STAIN
Version or Model: 070-60-0400/P
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AMERICAN TOOTH INDUSTRIES

Primary DI Number: D772ATI600400P0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 161532999 *Terms of Use

Device Description: MODIFYING STAIN 1/4 OZ SHADE PINK

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":	Yes
For Single-Use:	Yes
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?
45236	Temporary dental crown/bridge resin	A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBI	Resin, Denture, Relining, Repairing, Rebasing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 89d127a9-267c-4c3d-860d-b996cc38096c
Public Version Date: September 28, 2023
Public Version Number: 1
DI Record Publish Date: September 20, 2023