FDA.reportPublic FDA data

Cerawhite

Primary DI
06975409644008
Brand
Cerawhite
Company
Hangzhou Thales Medtech Co., Ltd.
Model
porcelain-crown/bridge
Published
2023-05-15
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
ELJTeeth, Artificial, Posterior With Metal Insert

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELJTeeth, Artificial, Posterior With Metal InsertDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975409644008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975409644008069754096440086975409644008

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
841846639
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975409640055ZrcoopAdditive manufacturing of zirconia porcelain crown2025-01-03
06975409640062ZrcoopAdditive manufacturing of zirconia porcelain venee2025-01-03
06975409640079ZrcoopAdditive manufacturing of zirconia inlays2025-01-03
06975409641007ZrcoopAdditive manufacturing of zirconia porcelain crown2025-01-03
06975409642004Cerawhiteporcelain-veneer2023-05-15
06975409643001Cerawhitecrown/bridge2023-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720604633771Vertex-Dental BVVertex-Dental B.V.ELJ2024-04-19
08720604633788Vertex-Dental BVVertex-Dental B.V.ELJ2024-04-19
08720604633795Vertex-Dental BVVertex-Dental B.V.ELJ2024-04-19
08720604633801Vertex-Dental BVVertex-Dental B.V.ELJ2024-04-19
08720604633818Vertex-Dental BVVertex-Dental B.V.ELJ2024-04-19
08720604633825Vertex-Dental BVVertex-Dental B.V.ELJ2024-04-19
08719425508924Vertex-Dental BVVertex-Dental B.V.ELJ2023-08-03
08719425508948Vertex-Dental BVVertex-Dental B.V.ELJ2023-08-03
08719425508955Vertex-Dental BVVertex-Dental B.V.ELJ2023-08-03
08719425508962Vertex-Dental BVVertex-Dental B.V.ELJ2023-08-03
08719425508979Vertex-Dental BVVertex-Dental B.V.ELJ2023-08-03
08719425508986Vertex-Dental BVVertex-Dental B.V.ELJ2023-08-03
06975409642004CerawhiteHangzhou Thales Medtech Co., Ltd.ELJ2023-05-15
06975409643001CerawhiteHangzhou Thales Medtech Co., Ltd.ELJ2023-05-15
00887919505587Brasseler USAPeter Brasseler Holdings, LLCELJ2022-12-08
00887919558736Brasseler USAPeter Brasseler Holdings, LLCELJ2022-12-08
00887919571919Brasseler USAPeter Brasseler Holdings, LLCELJ2022-12-08
08800003006052RAYDENT C&BRay Co., LtdELJ2022-11-03
08800003006069RAYDENT C&BRay Co., LtdELJ2022-11-03
08800003006076RAYDENT C&BRay Co., LtdELJ2022-11-03
08800003006083RAYDENT C&BRay Co., LtdELJ2022-11-03
18800003006004RAYDENT C&BRay Co., LtdELJ2022-11-03
18800003006011RAYDENT C&BRay Co., LtdELJ2022-11-03
18800003006028RAYDENT C&BRay Co., LtdELJ2022-11-03
18800003006035RAYDENT C&BRay Co., LtdELJ2022-11-03
18800003006042RAYDENT C&BRay Co., LtdELJ2022-11-03
00850039704178OnX Tough - Hollywood BleachSprintray, Inc.ELJ2022-10-04
00850039704079OnX - BleachSprintray, Inc.ELJ2022-02-28
00850039704086OnX - A1Sprintray, Inc.ELJ2022-02-28
00850039704093OnX - B1Sprintray, Inc.ELJ2022-02-28