FDA.reportPublic FDA data

CAD/CAM Resin Veneer

Primary DI
06975031820511
Brand
CAD/CAM Resin Veneer
Company
Beijing Yingguan Dental Technology Co., Ltd.
Model
/
Published
2022-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NSMRestoration, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSMRestoration, ResinUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975031820511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975031820511069750318205116975031820511

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
"[""Ozone"", ""Ultraviolet Light""]"
Ozone;Ultraviolet Light

Regulatory Flags#

DUNS number
560456141
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975031820016Cast Crown Ni-Cr (NP)/2022-09-30
06975031820023Cast Crown Co Cr (NP)/2022-09-30
06975031820030Cast Crown Pure Tianium/2022-09-30
06975031820047Cast Crown Noble Metal/2022-09-30
06975031820054PFM Crown Ni-Cr (NP)/2022-09-30
06975031820061PFM Crown Co Cr (NP)/2022-09-30
06975031820078PFM Crown Pure Titanium/2022-09-30
06975031820085PFM Crown Noble Metal/2022-09-30
06975031820092Cast Pontic Ni-Cr/2022-09-30
06975031820108Cast Pontic Co Cr/2022-09-30
06975031820115Cast Pontic Pure Titanium/2022-09-30
06975031820122Cast Pontic Noble Metal/2022-09-30
06975031820139PFM Pontic Ni-Cr/2022-09-30
06975031820146PFM Pontic Co Cr/2022-09-30
06975031820153PFM Pontic Pure Titanium/2022-09-30
06975031820160PFM Pontic Noble Metal/2022-09-30
06975031820177Fused Resin Pontic Ni-Cr/2022-09-30
06975031820184Fused Resin Pontic Co Cr/2022-09-30
06975031820191Fused Resin Pontic Pure Titanium/2022-09-30
06975031820207Fused Resin Pontic Noble Metal/2022-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975031820214Resin CrownBeijing Yingguan Dental Technology Co., Ltd.NSM2022-09-30
06975031820221Light-Cured Fused Resin CrownBeijing Yingguan Dental Technology Co., Ltd.NSM2022-09-30
06975031820238Light-Cured Fused Resin PonticBeijing Yingguan Dental Technology Co., Ltd.NSM2022-09-30
06975031820306Resin InlayBeijing Yingguan Dental Technology Co., Ltd.NSM2022-09-30
06975031820399Resin Post & CoreBeijing Yingguan Dental Technology Co., Ltd.NSM2022-09-30
06975031820467Resin VeneerBeijing Yingguan Dental Technology Co., Ltd.NSM2022-09-30
06975031820764CAD/CAM Crown ResinBeijing Yingguan Dental Technology Co., Ltd.NSM2022-09-30
06975031820771CAD/CAM Pontic ResinBeijing Yingguan Dental Technology Co., Ltd.NSM2022-09-30
06975031820887CAD/CAM Post & Core PEEKBeijing Yingguan Dental Technology Co., Ltd.NSM2022-09-30
06975031820900CAD/CAM Post & Core ResinBeijing Yingguan Dental Technology Co., Ltd.NSM2022-09-30
06975031820955CAD/CAM Inlay PEEKBeijing Yingguan Dental Technology Co., Ltd.NSM2022-09-30
06975031820979CAD/CAM Inlay ResinBeijing Yingguan Dental Technology Co., Ltd.NSM2022-09-30
D102BAR0Osteon MedicalIMPLANT SOLUTIONS PTY LTDNSM2022-07-26