AccessGUDID - DEVICE: Stoneglass Industries (D101SGI220)

GUDID

Device Identifier (DI) Information

Brand Name: Stoneglass Industries
Version or Model: SGI22
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SGI22
Company Name: STONEGLASS DENTAL LABORATORY PTY LTD

Primary DI Number: D101SGI220
Issuing Agency: HIBCC
Commercial Distribution End Date: January 01, 2999
Device Count: 1
Labeler D-U-N-S® Number*: 751548632 *Terms of Use

Device Description: ABC+DR Removable Prosthesis (Denture Teeth)

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:	Yes
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?
11172	Preformed complete denture	A prefabricated plastic plate designed to fit over an edentulous maxillary or mandibular alveolar ridge; an entire complement of artificial teeth from one arch is added to create a full denture. It is available in several standard sizes that can be contoured to custom fit the patient's ridge.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NSL	Dentures, Full

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: d3c13898-39ec-49f8-aac5-8b99533356a1
Public Version Date: May 06, 2022
Public Version Number: 1
DI Record Publish Date: April 28, 2022