FDA.reportPublic FDA data

Perfit OneML

Primary DI
08800325901325
Brand
Perfit OneML
Company
Vatech mcis Co., Ltd
Model
NU 16 C4OM W
Published
2026-07-20
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
EIFAccessories, Retractor, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIFAccessories, Retractor, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800325901325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800325901325088003259013258800325901325

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
688284886
Device count
1
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
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
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
08800325901394Perfit OneMLNU 16 BL4OM W2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800325900809Perfit OneMLVatech mcis Co., LtdEIF2026-07-22
08800325901202Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901219Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901226Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901233Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901240Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901257Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901264Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901271Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901288Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901295Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901301Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901318Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901332Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901349Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901356Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901363Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901370Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901387Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901394Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901400Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901417Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901424Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901431Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901448Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901455Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901462Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901479Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901486Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901493Perfit OneMLVatech mcis Co., LtdEIF2026-07-20