FDA.reportPublic FDA data

DENTECH

Primary DI
04560218682802
Brand
DENTECH
Company
DENTECH CORPORATION
Model
30075010
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
EJLBur, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560218682802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560218682802045602186828024560218682802

GMDN Terms#

Term, Definition table
TermDefinition
Fixture/appliance dental drill bit, reusableA shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. 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
00190776426736MillenniumAvalign Technologies, Inc.EJL2026-08-19
00190776426743MillenniumAvalign Technologies, Inc.EJL2026-08-19
04099797000726Drill for CT-tubeALTATEC GmbHEJL2026-08-17
04099797000733Drill for CT-tubeALTATEC GmbHEJL2026-08-17
04099797010664Surgery set CERALOG® PROGRESSIVE-LINE FlexALTATEC GmbHEJL2026-08-17
04099797011661Guide Template drillALTATEC GmbHEJL2026-08-17
04099797011678Guide Template drillALTATEC GmbHEJL2026-08-17
04099797011920Drill extensionALTATEC GmbHEJL2026-08-17
04099797012026Depth stopALTATEC GmbHEJL2026-08-17
04099797012033Depth stopALTATEC GmbHEJL2026-08-17
04099797012040Depth stopALTATEC GmbHEJL2026-08-17
04099797012057Depth stopALTATEC GmbHEJL2026-08-17
04099797012064Depth stopALTATEC GmbHEJL2026-08-17
04099797012071Depth stopALTATEC GmbHEJL2026-08-17
04099797012088Depth stopALTATEC GmbHEJL2026-08-17
04099797012095Depth stopALTATEC GmbHEJL2026-08-17
04099797012101Depth stopALTATEC GmbHEJL2026-08-17
04099797012118Point drillALTATEC GmbHEJL2026-08-17
04099797012125SCREW-LINE Form drillALTATEC GmbHEJL2026-08-17
04099797012132SCREW-LINE TapALTATEC GmbHEJL2026-08-17
04099797012354Pilot drill SetALTATEC GmbHEJL2026-08-17
04099797012361Pilot drill SetALTATEC GmbHEJL2026-08-17
04099797012378SCREW-LINE Form drillALTATEC GmbHEJL2026-08-17
04099797012385SCREW-LINE Form drillALTATEC GmbHEJL2026-08-17
04099797012392SCREW-LINE Form drillALTATEC GmbHEJL2026-08-17
04099797012408PROGRESSIVE-LINE Dense bone drillALTATEC GmbHEJL2026-08-17
04099797012415PROGRESSIVE-LINE Dense bone drillALTATEC GmbHEJL2026-08-17
04099797012422PROGRESSIVE-LINE Dense bone drillALTATEC GmbHEJL2026-08-17
04099797012439PROGRESSIVE-LINE Dense bone drillALTATEC GmbHEJL2026-08-17
04099797012446PROGRESSIVE-LINE Dense bone drill 2ALTATEC GmbHEJL2026-08-17