FDA.reportPublic FDA data

Denture, Restoration

Primary DI
08936214225019
Brand
Denture, Restoration
Company
ACESO DENTAL LABORATORY COMPANY LIMITED
Model
500
Published
2022-10-20
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
NSJRestoration, Noble Metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSJRestoration, Noble MetalUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08936214225002PrimaryGS10
08936214225019Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08936214225002089362142250028936214225002
08936214225019089362142250198936214225019

GMDN Terms#

Term, Definition table
TermDefinition
Complete upper dentureA custom-made artificial replacement for all teeth in the upper jaw (maxilla) carried on a removable plate or frame which is supported by surrounding soft and hard tissues of the oral cavity. It can be made of a variety of materials including polymers [polymethylmethacrylate (PMMA), polycarbonate (PC)], acrylic, ceramics, and/or metals [e.g., base metal alloys or titanium (Ti)].

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
673251143
Device count
5
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
08936214229987Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2023-02-20
08936214223305Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214223329RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224005Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224029Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224067Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224081Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224104Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224128Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224166Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214225002Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214223312Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214223336RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224012Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224036Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224074Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224098Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224111Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224135Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224173Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214223121Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-18
08936214223169Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-18
08936214223220RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-18
08936214223282Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-18
08936214223138Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-18
08936214223176Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-18
08936214223237RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-18
08936214223299Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-18
08936214221240Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-17
08936214221264Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-17