FDA.reportPublic FDA data

ULTRATHINEER

Primary DI
06977053950047
Brand
ULTRATHINEER
Company
BMF Tech (Zhuhai) Inc.
Model
Zirconia-based porcelain veneer
Published
2024-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NSPRestoration, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSPRestoration, PorcelainUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977053950047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977053950047069770539500476977053950047

GMDN Terms#

Term, Definition table
TermDefinition
Dental veneer, professionalA custom-made dental restoration made of ceramic or polymer-based material (resin) intended to be used in aesthetic dentistry to correct the facial surface of a tooth; it is intended to be applied to the teeth by a dental professional for long-term use, typically via an adhesive. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
636367167
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06977053950054ULTRATHINEERZirconia veneer2024-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977053950054ULTRATHINEERBMF Tech (Zhuhai) Inc.NSP2024-12-08
06977512700008DTS, RESTORATION, PORCELAINDTS Digital Dental LabNSP2024-06-13
06977512700015DTS, RESTORATION, PORCELAINDTS Digital Dental LabNSP2024-06-13
06977512700022DTS, RESTORATION, PORCELAINDTS Digital Dental LabNSP2024-06-13
08936214229987Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSP2023-02-20
08936214223329RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214223367Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214223381RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214224029Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214224043Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214224067Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214224081Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214224104Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214224128Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214224142Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214225002Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214223169Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-18
08936214223206RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-18
08936214223244Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-18
08936214223268Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-18
08936214221301Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-17
08936214223022Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-17
08936214223046RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-17
08936214223084Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-17
08936214223107RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-17
08936214221318Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-17
08936214221226Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-13
08936214221028RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-12
08936214221066RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-12
08936214221080Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-12