FDA.reportPublic FDA data

Perfit ZR

Primary DI
08800099901989
Brand
Perfit ZR
Company
Vatech mcis Co., Ltd
Model
NP 14 white W
Published
2021-08-31
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
08800099901989PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800099901989088000999019898800099901989

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
06942629805069Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-22
06942629805298Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-22
06942629805526Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-22
06942629805755Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-22
06942629805984Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-22
06942629805090Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805229Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805236Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805243Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805328Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805458Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805465Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805472Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805557Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805571Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805687Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805694Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805700Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805915Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805922Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805939Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805946Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806011Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806141Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806158Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806165Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806172Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806264Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806387Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806394Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21