FDA.reportPublic FDA data

Stoneglass Industries

Primary DI
D101SGI280
Brand
Stoneglass Industries
Company
STONEGLASS DENTAL LABORATORY PTY LTD
Model
SGI28
Catalog number
SGI28
Device description
Zirconia crown
Published
2024-02-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NSNRestoration, Resin, Crown And Bridge

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSNRestoration, Resin, Crown And BridgeUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D101SGI280PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental bridge, metal-ceramicA custom-made, non-removable, artificial replacement for one or more missing teeth made of metal alloy combined with tooth-coloured ceramic material (veneer), and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+61297641036pdc@stoneglass.com.au

Regulatory Flags#

DUNS number
751548632
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D101SGI1590Stoneglass IndustriesSGI159SGI1592024-04-05
D101SGI1490Stoneglass IndustriesSGI149SGI1492023-12-21
D101SGI1250Stoneglass IndustriesSGI125SGI1252023-12-05
D101SGI1460Stoneglass IndustriesSGI146SGI1462023-09-12
D101SGI1430Stoneglass IndustriesSGI143SGI1432023-06-01
D101SGI170Stoneglass IndustriesSGI17SGI172023-04-05
D101SGI240Stoneglass IndustriesSGI24SGI242023-03-06
D101SGI650Stoneglass IndustriesSGI65SGI652022-07-21
D101SGI1050Stoneglass IndustriesSGI105SGI1052022-06-09
D101SGI870Stoneglass IndustriesSGI87SGI872022-06-01
D101SGI1040Stoneglass IndustriesSGI104SGI1042022-04-28
D101SGI1080Stoneglass IndustriesSGI108SGI1082022-04-28
D101SGI160Stoneglass IndustriesSGI16SGI162022-04-28
D101SGI180Stoneglass IndustriesSGI18SGI182022-04-28
D101SGI190Stoneglass IndustriesSGI19SGI192022-04-28
D101SGI200Stoneglass IndustriesSGI20SGI202022-04-28
D101SGI220Stoneglass IndustriesSGI22SGI222022-04-28
D101SGI50Stoneglass IndustriesSGI5SGI52022-04-28
D101SGI750Stoneglass IndustriesSGI75SGI752022-04-27
D101SGI770Stoneglass IndustriesSGI77SGI772022-04-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977512700060DTS, RESTORATION, RESIN, CROWN ANDDTS Digital Dental LabNSN2024-06-13
D101SGI240Stoneglass IndustriesSTONEGLASS DENTAL LABORATORY PTY LTDNSN2023-03-06
08936214229987Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSN2023-02-20
08936214223305Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-20
08936214223343Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-20
08936214223381RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-20
08936214224104Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-20
08936214224128Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-20
08936214224142Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-20
08936214224166Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-20
08936214223398RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-20
08936214223145Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-18
08936214223169Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-18
08936214223183Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-18
08936214223206RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-18
08936214223220RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-18
08936214223244Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-18
08936214223213RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-18
08936214221240Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-17
08936214221325Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-17
08936214221189Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-13
08936214221141Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-12
08936214221165Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-12
08936214221158Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-12
08936214221172Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-12
08936214220052RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-03
06975031820641CAD/CAM Fused Resin Crown PEEKBeijing Yingguan Dental Technology Co., Ltd.NSN2022-09-30
06975031820696CAD/CAM Fused Resin Pontic PEEKBeijing Yingguan Dental Technology Co., Ltd.NSN2022-09-30
06975031820740CAD/CAM Crown PEEKBeijing Yingguan Dental Technology Co., Ltd.NSN2022-09-30
06975031820825CAD/CAM Pontic PEEKBeijing Yingguan Dental Technology Co., Ltd.NSN2022-09-30