FDA.reportPublic FDA data

Restoration

Primary DI
08936214221073
Brand
Restoration
Company
ACESO DENTAL LABORATORY COMPANY LIMITED
Model
106
Published
2022-10-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NSORestoration, Porcelain-Fused-To-Metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSORestoration, Porcelain-Fused-To-MetalUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08936214221066PrimaryGS10
08936214221073Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08936214221066089362142210668936214221066
08936214221073089362142210738936214221073

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
673251143
Device count
2
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
06977512700084DTS, RESTORATION, PORCELAIN-FUSEDDTS Digital Dental LabNSO2024-06-13
08936214229987Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSO2023-02-20
08936214229994Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSO2023-02-20
08936214223343Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224005Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224029Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224043Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224081Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224128Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224142Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224166Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214225002Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214223183Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-18
08936214223206RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-18
08936214223220RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-18
08936214223268Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-18
08936214223282Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-18
08936214221288RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-17
08936214223008Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-17
08936214223046RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-17
08936214223060Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-17
08936214223107RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-17
08936214221295RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-17
08936214221202Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-13
08936214221066RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-12
08936214221103Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-12
08936214221141Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-12
08936214220014RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-03
06975031820054PFM Crown Ni-Cr (NP)Beijing Yingguan Dental Technology Co., Ltd.NSO2022-09-30
06975031820061PFM Crown Co Cr (NP)Beijing Yingguan Dental Technology Co., Ltd.NSO2022-09-30