FDA.reportPublic FDA data

DENTECH

Primary DI
04560218668493
Brand
DENTECH
Company
DENTECH CORPORATION
Model
07000150
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04560218668493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560218668493045602186684934560218668493

GMDN Terms#

Term, Definition table
TermDefinition
Mouth gag, non-adjustableA mechanical device without adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral surgical intervention. It is designed to be inserted between the teeth to force the jaws apart and may be in the form of a wedge block, wedge screw, or sprung wedge. Depending on the design it may also be referred to as a jaw spreader, oral wood screw, or mouth prop. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
700723000
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04560218663887DENTECH030500002020-09-24
04560218681928DENTECH300604302020-09-24
04560218681935DENTECH300605002020-09-24
04560218681942DENTECH300602402020-09-24
04560218681959DENTECH300602702020-09-24
04560218681966DENTECH300603002020-09-24
04560218681973DENTECH300603302020-09-24
04560218681980DENTECH300603802020-09-24
04560218681997DENTECH300606002020-09-24
04560218682109DENTECH300706002020-09-24
04560218682116DENTECH300708002020-09-24
04560218682123DENTECH300710002020-09-24
04560218682154DENTECH300705002020-09-24
04560218682161DENTECH300712002020-09-24
04560218676818DENTECH300147422024-01-17
04560218669773DENTECH010149992022-08-26
04560218660718DENTECH500300002021-09-30
04560218660442DENTECH010182122020-09-24
04560218660589DENTECH507106002020-09-24
04560218660596DENTECH507107002020-09-24

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
08800325901325Perfit 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