FDA.reportPublic FDA data

CERAMASTER

Primary DI
E2350332C0
Brand
CERAMASTER
Company
SHOFU DENTAL CORPORATION
Model
0332C
Catalog number
0332C
Device description
CERAMASTER DISPLAY BLOCK
Published
2021-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EHLPOINT, ABRASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHLPoint, AbrasiveDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E2350332C0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Instrument storage cabinetA furniture-like device designed for general-purpose use, typically where surgery is practised and carried out, to store and possibly display surgical instruments and other devices/products which will be used during surgical examinations/procedures. It will typically consist of double doors with glass windows in them that close off the shelving, and multiple drawers where the instruments are kept. It can be made of stainless steel, plastic materials, glass and wood. This device will typically be used in operating and procedure rooms, including dental, ophthalmological clinics, and doctors surgeries.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)827-5262customer-service@shofu.com

Regulatory Flags#

DUNS number
054618202
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E235DPC0DentaprintDPCDPC2026-04-29
E235DPM0DentaprintDPMDPM2026-04-29
E235DPOM0DentaprintDPOMDPOM2026-04-29
E235DPSG0DentaprintDPSGDPSG2026-04-29
E235DPTIA10DentaprintDPTIA1DPTIA12026-04-29
E235DPTIA2DentaprintDPTIA2DPTIA22026-04-29
E235DPTIBW0DentaprintDPTIBWDPTIBW2026-04-29
04548162224736GlasIonomer FX ULTRA112511252026-04-10
04548162224743GlasIonomer FX ULTRA112611262026-04-10
04548162224750GlasIonomer FX ULTRA112711272026-04-10
04548162224767GlasIonomer FX ULTRA112811282026-04-10
04548162265111VINTAGE Art UniversalP1695P16952026-04-10
04548162267207VINTAGE Art UniversalP0691P06912026-04-10
04548162267214VINTAGE Art UniversalP0693P06932026-04-10
04548162267221VINTAGE Art UniversalP0692P06922026-04-10
04548162267238VINTAGE Art UniversalP0694P06942026-04-10
04548162267245VINTAGE Art UniversalP0695P06952026-04-10
04548162267252VINTAGE Art UniversalP0696P06962026-04-10
04548162267269VINTAGE Art UniversalP0697P06972026-04-10
04548162267276VINTAGE Art UniversalP0698P06982026-04-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07897990301155PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990301209PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990301216PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399756PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399763PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399770PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399787PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399794PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399800PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399817PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399824PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399831PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399848PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399855PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399862PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399886PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399893PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399909PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399916PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399923PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399930PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399947PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399954PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
08404535025101Brasseler USAPeter Brasseler Holdings, LLCEHL2026-05-11
07630049901094Diacomp flame, pu: 6 pcsDiaswiss SAEHL2023-10-02
07630049901773Diabrush cup, pu: 2 pcsDiaswiss SAEHL2023-10-02
07630049984073Diaceram 2-step cup, pu: 6 pcsDiaswiss SAEHL2023-10-02
07630049984554Diabrownies flame, pu: 6 pcsDiaswiss SAEHL2023-10-02
07630049984578Diabrownies cup, pu: 6 pcsDiaswiss SAEHL2023-10-02
07630049984592Diabrownies flame, pu: 6 pcsDiaswiss SAEHL2023-10-02