FDA.reportPublic FDA data

RAYDENT C&B

Primary DI
08800003006052
Brand
RAYDENT C&B
Company
Ray Co., Ltd
Model
RCB02B
Published
2022-11-03
Public version status
Update
Distribution status
Not 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
08800003006052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800003006052088000030060528800003006052

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690324087
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800003027026RAYSCANScan Ceph2025-12-01
08800003027002RAYSCAN α+, Vision 16, RCT700RCT7002025-08-25
08800003027019RAYSCANScan Ceph (SC)2025-08-25
08800003027033RAYSCANOne Shot Ceph Small2025-08-25
08800003027040RAYSCANOne Shot Ceph Large2025-08-25
08800003027057RAYSCAN STUDIO, Vision 20, RAYPreMiere, RAYSCAN S, Vision 18, RCT800RCT8002025-08-25
08800003027088RAYSCAN α-Expert, RAYSCAN α-PRAYSCAN α-P2025-08-25
08800003027095RAYSCAN α-Expert 3D, RAYSCAN α-3DRAYSCAN α-3D2025-08-25
08800003027064RAYQuantum, RCT600RCT6002025-04-14
08800003027071RAYQuantumScan Ceph2025-04-14
08800003005017SMARTDent3.1.0.02025-05-28
08800003001002RAYSCAN α+RCT7002020-05-08
08800003004003RAYSCAN StudioRCT800 2020-05-08
08800003003013RIOScanRPS500 (STD)2016-10-05
08800003003020RIOScanRPS500 (OCC)2016-10-05
08800003003310RIOScanIP Size 0 2016-10-05
08800003003327RIOScanIP Size 12016-10-05
08800003003334RIOScanIP Size 22016-10-05
08800003003341RIOScanIP Size 32016-10-05
08800003003358RIOScanIP Size 42016-10-05

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
06975409644008CerawhiteHangzhou 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
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