FDA.reportPublic FDA data

Razor

Primary DI
08800118648604
Brand
Razor
Company
U&C International Co.,Ltd
Model
C 1100 B3 B55
Published
2026-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191902000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191902000Razor, Everest, U&C LiquidU&C International Co., Ltd.2019-10-11EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800118648604PrimaryGS10
08800118658306Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800118648604088001186486048800118648604
08800118658306088001186583068800118658306

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.

Regulatory Flags#

DUNS number
694821663
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
08800118648406RazorC 1100 B2 B202026-09-04
08800118648413RazorC 1100 B2 B402026-09-04
08800118648420RazorC 1100 B2 B402026-09-04
08800118648437RazorC 1100 B2 B402026-09-04
08800118648444RazorC 1100 B2 B402026-09-04
08800118648451RazorC 1100 B2 B552026-09-04
08800118648468RazorC 1100 B2 B552026-09-04
08800118648475RazorC 1100 B2 B552026-09-04
08800118648482RazorC 1100 B2 B552026-09-04
08800118648499RazorC 1100 B3 B202026-09-04
08800118648505RazorC 1100 B3 B202026-09-04
08800118648512RazorC 1100 B3 B202026-09-04
08800118648529RazorC 1100 B3 B202026-09-04
08800118648536RazorC 1100 B3 B202026-09-04
08800118648543RazorC 1100 B3 B402026-09-04
08800118648550RazorC 1100 B3 B402026-09-04
08800118648567RazorC 1100 B3 B402026-09-04
08800118648574RazorC 1100 B3 B402026-09-04
08800118648581RazorC 1100 B3 B402026-09-04
08800118648598RazorC 1100 B3 B552026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06941382296862Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296916Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296923Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296930Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296947Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296954Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296961Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
08800118648406RazorU&C International Co.,LtdEIH2026-09-04
08800118648413RazorU&C International Co.,LtdEIH2026-09-04
08800118648420RazorU&C International Co.,LtdEIH2026-09-04
08800118648437RazorU&C International Co.,LtdEIH2026-09-04
08800118648444RazorU&C International Co.,LtdEIH2026-09-04
08800118648451RazorU&C International Co.,LtdEIH2026-09-04
08800118648468RazorU&C International Co.,LtdEIH2026-09-04
08800118648475RazorU&C International Co.,LtdEIH2026-09-04
08800118648482RazorU&C International Co.,LtdEIH2026-09-04
08800118648499RazorU&C International Co.,LtdEIH2026-09-04
08800118648505RazorU&C International Co.,LtdEIH2026-09-04
08800118648512RazorU&C International Co.,LtdEIH2026-09-04
08800118648529RazorU&C International Co.,LtdEIH2026-09-04
08800118648536RazorU&C International Co.,LtdEIH2026-09-04
08800118648543RazorU&C International Co.,LtdEIH2026-09-04
08800118648550RazorU&C International Co.,LtdEIH2026-09-04
08800118648567RazorU&C International Co.,LtdEIH2026-09-04
08800118648574RazorU&C International Co.,LtdEIH2026-09-04
08800118648581RazorU&C International Co.,LtdEIH2026-09-04
08800118648598RazorU&C International Co.,LtdEIH2026-09-04
08800118648611RazorU&C International Co.,LtdEIH2026-09-04
08800118648628RazorU&C International Co.,LtdEIH2026-09-04
08800118648635RazorU&C International Co.,LtdEIH2026-09-04