FDA.reportPublic FDA data

Restoration

Primary DI
08936214220076
Brand
Restoration
Company
ACESO DENTAL LABORATORY COMPANY LIMITED
Model
007
Device description
Base metal restorations are crowns, bridges, inlays, and onlays that are manufactured as finished products from base metals.
Published
2022-10-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NSQRestoration, Base Metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSQRestoration, Base MetalUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08936214220076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08936214220076089362142200768936214220076

GMDN Terms#

Term, Definition table
TermDefinition
Dental casting non-noble alloyA material composed primarily of non-noble metals [e.g., includes alloys such as cobalt-chrome (Co-Cr), nickel-chromium, titanium (Ti)] intended for use in the fabrication of a dental cast [i.e., a positive copy of a part of the oral anatomy made in an impression (mould), such as a dental crown] or dental restorations and appliances (e.g., porcelain-fused-to-metal crowns and bridge restorations). It is typically available in the form of small ingots or bars that are melted and poured into an impression. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
673251143
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08936214221028Restoration1022022-10-12
08936214221066Restoration1062022-10-12
08936214221080Denture, Restoration 1082022-10-12
08936214221103Denture, Restoration 1102022-10-12
08936214221127Denture, Restoration 1122022-10-12
08936214221141Restoration 1142022-10-12
08936214221165Restoration 1162022-10-12
08936214221189Denture, Restoration 1182022-10-13
08936214221202Denture, Restoration 1202022-10-13
08936214221226Denture, Restoration 1222022-10-13
08936214221240Restoration 1242022-10-17
08936214221264Denture, Restoration 1262022-10-17
08936214221288Restoration1282022-10-17
08936214221301Restoration 1302022-10-17
08936214221325Denture, Restoration 1322022-10-17
08936214221349Restoration 1342022-10-17
08936214221363Denture, Surgical guide1362022-10-17
08936214223008Denture, Restoration 3002022-10-17
08936214223022Denture, Restoration 3022022-10-17
08936214223046Restoration3042022-10-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08936214229987Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSQ2023-02-20
08936214223329RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSQ2022-10-20
08936214223367Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSQ2022-10-20
08936214223381RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSQ2022-10-20
08936214221288RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSQ2022-10-17
08936214221301Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSQ2022-10-17
08936214221349Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSQ2022-10-17
06975031820092Cast Pontic Ni-CrBeijing Yingguan Dental Technology Co., Ltd.NSQ2022-09-30
06975031820108Cast Pontic Co CrBeijing Yingguan Dental Technology Co., Ltd.NSQ2022-09-30
06975031820115Cast Pontic Pure TitaniumBeijing Yingguan Dental Technology Co., Ltd.NSQ2022-09-30
06975031820177Fused Resin Pontic Ni-CrBeijing Yingguan Dental Technology Co., Ltd.NSQ2022-09-30
06975031820184Fused Resin Pontic Co CrBeijing Yingguan Dental Technology Co., Ltd.NSQ2022-09-30
06975031820191Fused Resin Pontic Pure TitaniumBeijing Yingguan Dental Technology Co., Ltd.NSQ2022-09-30
06975031820313Inlay Ni-CrBeijing Yingguan Dental Technology Co., Ltd.NSQ2022-09-30
06975031820320Inlay Co CrBeijing Yingguan Dental Technology Co., Ltd.NSQ2022-09-30
06975031820337Inlay Titanium AlloyBeijing Yingguan Dental Technology Co., Ltd.NSQ2022-09-30
06975031820344Inlay Pure TitaniumBeijing Yingguan Dental Technology Co., Ltd.NSQ2022-09-30
06975031820405Post & Core Ni-CrBeijing Yingguan Dental Technology Co., Ltd.NSQ2022-09-30
06975031820412Post & Core Co CrBeijing Yingguan Dental Technology Co., Ltd.NSQ2022-09-30
06975031820429Post & Core Pure TitaniumBeijing Yingguan Dental Technology Co., Ltd.NSQ2022-09-30
06975031820566CAD/CAM PFM Pontic Ni-CrBeijing Yingguan Dental Technology Co., Ltd.NSQ2022-09-30
06975031820573CAD/CAM PFM Pontic Co CrBeijing Yingguan Dental Technology Co., Ltd.NSQ2022-09-30
06975031820580CAD/CAM PFM Pontic Titanium AlloyBeijing Yingguan Dental Technology Co., Ltd.NSQ2022-09-30
06975031820597CAD/CAM PFM Pontic Pure TitaniumBeijing Yingguan Dental Technology Co., Ltd.NSQ2022-09-30
06975031820603CAD/CAM Fused Resin Crown Ni-CrBeijing Yingguan Dental Technology Co., Ltd.NSQ2022-09-30
06975031820610CAD/CAM Fused Resin Crown Co CrBeijing Yingguan Dental Technology Co., Ltd.NSQ2022-09-30
06975031820627CAD/CAM Fused Resin Crown Titanium AlloyBeijing Yingguan Dental Technology Co., Ltd.NSQ2022-09-30
06975031820634CAD/CAM Fused Resin Crown Pure TitaniumBeijing Yingguan Dental Technology Co., Ltd.NSQ2022-09-30
06975031820658CAD/CAM Fused Resin Pontic Ni-CrBeijing Yingguan Dental Technology Co., Ltd.NSQ2022-09-30
06975031820665CAD/CAM Fused Resin Pontic Co CrBeijing Yingguan Dental Technology Co., Ltd.NSQ2022-09-30