AccessGUDID - DEVICE: InstaGums® Soft Tissue Material (00841549118524)

GUDID

Device Identifier (DI) Information

Brand Name: InstaGums® Soft Tissue Material
Version or Model: 222025
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: STERNGOLD DENTAL LLC

Primary DI Number: 00841549118524
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 124763728 *Terms of Use

Device Description: 1x50ml cart.15 mix&15 oral tips. Self-curing, tissue colored silicone, a gingival reproduction material.

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?
35866	Silicone dental impression material	An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.	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 [?]
K992609	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: 81850962-9e20-468a-9bf8-8f1c79f8071a
Public Version Date: May 29, 2025
Public Version Number: 2
DI Record Publish Date: July 18, 2023