Stoneglass Industries

Basic Information

• Brand Name: Stoneglass Industries
• Primary DI: D101SGI160
• Version / Model: SGI16
• Catalog Number: SGI16
• Company Name: STONEGLASS DENTAL LABORATORY PTY LTD
• Labeler DUNS: 751548632
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-28
• Public Version: 1
• Public Version Date: 2022-05-06
• Public Version Status: New
• Public Device Record Key: d50883b8-f838-4d75-b29d-99678faf4a54
• Distribution End Date: 2999-01-01

Device Description

Fixed Prototype Prosthesis with Denture Teeth

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NSL	Dentures, Full	Unknown		N

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D101SGI160	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]