FDA.reportPublic FDA data

DENTECH

Primary DI
04560218681973
Brand
DENTECH
Company
DENTECH CORPORATION
Model
30060330
Published
2020-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EJLBur, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560218681973PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560218681973045602186819734560218681973

GMDN Terms#

Term, Definition table
TermDefinition
Bone trephineAn orthopaedic surgical blade designed to cut and remove circular sections of bone, typically for biopsy or percutaneous bone graft harvesting. It is typically a hollow cylinder with a circular, saw-like serrated working edge. It is an exchangeable device that may be attached to a manually-operated handle or to a powered rotary surgical handpiece. The device is typically made of high-grade stainless steel. 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
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
04560218667120DENTECH061221002020-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887919170488Brasseler USA Sterile CarbidePeter Brasseler Holdings, LLCEJL2026-05-27
07908611200822TUNGSTEN CARBIDE CUTTING BUR CC136FX LOW SPEED - 1UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJL2026-05-27
08404535030006Brasseler USA Sterile CarbidePeter Brasseler Holdings, LLCEJL2026-05-27
08404535030037Brasseler USA Sterile CarbidePeter Brasseler Holdings, LLCEJL2026-05-27
08435389830436EXTRA SHORT DRILL; Ø3.5 MMBIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
08435389830542FLATTENING FRONT CUTTING DRILL; Ø3.1BIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
08435389830559FLATTENING FRONT CUTTING SHORT DRILL; Ø3.1BIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
08435389831266FLATTENING FRONT CUTTING DRILL, Ø4.1 INTERNA 3.0BIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
ESUNC1623160165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2025-04-29
07630049901384C141 Allport bone cutterDiaswiss SAEJL2023-10-02
07630049901612DIA-ZDiaswiss SAEJL2023-10-02
07630049902077Carbide bur Diacarb RADiaswiss SAEJL2023-10-02
07630049951051Carbide bur Diacarb RADiaswiss SAEJL2023-10-02
07630049951075Carbide bur Diacarb RADiaswiss SAEJL2023-10-02
07630049951532Carbide bur Diacarb FG HCDiaswiss SAEJL2023-10-02
07630049951556FG Diacarb finishing bur HCDiaswiss SAEJL2023-10-02
ESUNC283K3140165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-25
ESUNC33L3140105Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNC33L3140125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040185Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040215Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040235Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040275Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCTR323140125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040145Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040215Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040235Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNC463140145Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-07