FDA.reportPublic FDA data

Perfit OneML

Primary DI
08800325901561
Brand
Perfit OneML
Company
Vatech mcis Co., Ltd
Model
NU 18 BL1OM 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
08800325901561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800325901561088003259015618800325901561

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
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
06954454000250COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000885COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000892COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000908COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000915COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000922COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000939COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000946COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000953COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000960COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002001COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002308COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002315COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002803COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002810COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002827COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002834COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002841COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454004876COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454005019COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454005026COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006085COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006214COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006221COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006245COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006252COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006429COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454011867COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454013489COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454013496COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21