FDA.reportPublic FDA data

ULTRATHINEER

Primary DI
06977053950054
Brand
ULTRATHINEER
Company
BMF Tech (Zhuhai) Inc.
Model
Zirconia veneer
Published
2024-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
06977053950054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977053950054069770539500546977053950054

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
DM exempt
false
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06977053950047ULTRATHINEERZirconia-based porcelain veneer2024-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977053950047ULTRATHINEERBMF 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
08936214221318Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-17
08936214220021RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-03
06975031820016Cast Crown Ni-Cr (NP)Beijing Yingguan Dental Technology Co., Ltd.NSP2022-09-30
06975031820023Cast Crown Co Cr (NP)Beijing Yingguan Dental Technology Co., Ltd.NSP2022-09-30
06975031820030Cast Crown Pure TianiumBeijing Yingguan Dental Technology Co., Ltd.NSP2022-09-30
06975031820245FMC CrownBeijing Yingguan Dental Technology Co., Ltd.NSP2022-09-30
06975031820252All-Ceramic CrownBeijing Yingguan Dental Technology Co., Ltd.NSP2022-09-30
06975031820269FMC Pontic CeramicBeijing Yingguan Dental Technology Co., Ltd.NSP2022-09-30
06975031820276All-Ceramic PonticBeijing Yingguan Dental Technology Co., Ltd.NSP2022-09-30
06975031820283CAD/CAM Crown ZirconiaBeijing Yingguan Dental Technology Co., Ltd.NSP2022-09-30
06975031820290CAD/CAM Pontic ZirconiaBeijing Yingguan Dental Technology Co., Ltd.NSP2022-09-30
06975031820375FMC InlayBeijing Yingguan Dental Technology Co., Ltd.NSP2022-09-30
06975031820382CAD/CAM Inlay ZirconiaBeijing Yingguan Dental Technology Co., Ltd.NSP2022-09-30
06975031820443FMC Post & CoreBeijing Yingguan Dental Technology Co., Ltd.NSP2022-09-30
06975031820450CAD/CAM Post & Core ZirconiaBeijing Yingguan Dental Technology Co., Ltd.NSP2022-09-30
06975031820474FMC VeneerBeijing Yingguan Dental Technology Co., Ltd.NSP2022-09-30
06975031820498Glass Ceramic VeneerBeijing Yingguan Dental Technology Co., Ltd.NSP2022-09-30
06975031820504CAD/CAM Veneer ZirconiaBeijing Yingguan Dental Technology Co., Ltd.NSP2022-09-30
06975031820757CAD/CAM Crown Glass CeramicBeijing Yingguan Dental Technology Co., Ltd.NSP2022-09-30
06975031820832CAD/CAM Pontic Glass CeramicBeijing Yingguan Dental Technology Co., Ltd.NSP2022-09-30
06975031820894CAD/CAM Post & Core Glass CeramicBeijing Yingguan Dental Technology Co., Ltd.NSP2022-09-30
06975031820962CAD/CAM Inlay Glass CeramicBeijing Yingguan Dental Technology Co., Ltd.NSP2022-09-30
06975031821174SLM Crown Co CrBeijing Yingguan Dental Technology Co., Ltd.NSP2022-09-30
06972677870054 RestorationModern Dental Laboratory (DG) Co., Ltd.NSP2020-07-21
06972677871259Restoration, orthodonticModern Dental Laboratory (DG) Co., Ltd.NSP2020-07-21
06972677871471Restoration Modern Dental Laboratory (DG) Co., Ltd.NSP2020-07-21