FDA.reportPublic FDA data

Perfit ZR

Primary DI
08800099907516
Brand
Perfit ZR
Company
Vatech mcis Co., Ltd
Model
NU 14 C2TM W
Published
2021-11-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K203499000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203499000Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blankVatech Acucera, Inc.2021-04-05EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800099907516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800099907516088000999075168800099907516

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
688284886
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800325900809Perfit OneMLNU 12 A1OM W2026-07-22
08800325901202Perfit OneMLNU 16 A1OM W2026-07-20
08800325901219Perfit OneMLNU 16 A2OM W2026-07-20
08800325901226Perfit OneMLNU 16 A3OM W2026-07-20
08800325901233Perfit OneMLNU 16 A3.5OM W2026-07-20
08800325901240Perfit OneMLNU 16 A4OM W2026-07-20
08800325901257Perfit OneMLNU 16 B1OM W2026-07-20
08800325901264Perfit OneMLNU 16 B2OM W2026-07-20
08800325901271Perfit OneMLNU 16 B3OM W2026-07-20
08800325901288Perfit OneMLNU 16 B4OM W2026-07-20
08800325901295Perfit OneMLNU 16 C1OM W2026-07-20
08800325901301Perfit OneMLNU 16 C2OM W2026-07-20
08800325901318Perfit OneMLNU 16 C3OM W2026-07-20
08800325901325Perfit OneMLNU 16 C4OM W2026-07-20
08800325901332Perfit OneMLNU 16 D2OM W2026-07-20
08800325901349Perfit OneMLNU 16 D3OM W2026-07-20
08800325901356Perfit OneMLNU 16 D4OM W2026-07-20
08800325901363Perfit OneMLNU 16 BL1OM W2026-07-20
08800325901370Perfit OneMLNU 16 BL2OM W2026-07-20
08800325901387Perfit OneMLNU 16 BL3OM W2026-07-20

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
08800118648604RazorU&C International Co.,LtdEIH2026-09-04
08800118648611RazorU&C International Co.,LtdEIH2026-09-04
08800118648628RazorU&C International Co.,LtdEIH2026-09-04