FDA.reportPublic FDA data

Stoneglass Industries

Primary DI
D101SGI1250
Brand
Stoneglass Industries
Company
STONEGLASS DENTAL LABORATORY PTY LTD
Model
SGI125
Catalog number
SGI125
Device description
Dentabite Occlusal Splint
Published
2023-12-05
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
NSLDentures, Full

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSLDentures, FullUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D101SGI1250PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Preformed complete dentureA 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.

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
D101SGI280Stoneglass IndustriesSGI28SGI282024-02-08
D101SGI1490Stoneglass IndustriesSGI149SGI1492023-12-21
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
00810126380159Set Full DentureDigital Dental Laboratories, IncNSL2026-02-25
00810126380166Finish Full DentureDigital Dental Laboratories, IncNSL2026-02-25
06977512700046DTS, DENTURES, FULLDTS Digital Dental LabNSL2024-06-13
06977512700091DTS, DENTURES, FULLDTS Digital Dental LabNSL2024-06-13
D101SGI1590Stoneglass IndustriesSTONEGLASS DENTAL LABORATORY PTY LTDNSL2024-04-05
D101SGI1490Stoneglass IndustriesSTONEGLASS DENTAL LABORATORY PTY LTDNSL2023-12-21
D101SGI1460Stoneglass IndustriesSTONEGLASS DENTAL LABORATORY PTY LTDNSL2023-09-12
D101SGI1430Stoneglass IndustriesSTONEGLASS DENTAL LABORATORY PTY LTDNSL2023-06-01
D101SGI170Stoneglass IndustriesSTONEGLASS DENTAL LABORATORY PTY LTDNSL2023-04-05
08936214229987Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSL2023-02-20
08936214223305Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214223367Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214224005Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214224029Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214224043Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214224067Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214224104Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214224142Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214224166Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214225002Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214223374Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214224159Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214223121Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-18
08936214223145Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-18
08936214223183Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-18
08936214223244Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-18
08936214223190Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-18
08936214223251Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-18
08936214221363Denture, Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-17
08936214223008Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-17