FDA.reportPublic FDA data

DRILL BIT

Primary DI
07290113355781
Brand
DRILL BIT
Company
DENTIN IMPLANTS TECHNOLOGIES LTD
Model
DDR-1042
Device description
Drill dia 4.2 L 10 mm
Published
2018-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DZADrill, Dental, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290113355781PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290113355781072901133557817290113355781

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
600215680
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290113355941TREPHINE DRILLDDR-TR032018-09-10
07290113355958TREPHINE DRILLDDR-TR042018-09-10
07290113355965TREPHINE DRILLDDR-TR052018-09-10
07290113356252IMPLANTOLOGY TOOLSDCT-08002018-09-10
07290113356269IMPLANTOLOGY TOOLSDCT-08102018-09-10
07290113356917PROSTHETIC SCREWSSSU-16242019-09-11
072901133538793D SCANNINGGAHM-002018-09-10
072901133538863D SCANNINGGAHM-092018-09-10
072901133538933D SCANNINGGAHM-182018-09-10
072901133539093D SCANNINGGAHM-302018-09-10
072901133545003D SCANNINGSMS-00402018-09-10
072901133545173D SCANNINGSMS-60402018-09-10
072901133545863D SCANNINGSWS-00402018-09-10
072901133545933D SCANNINGSWS-60402018-09-10
07290113356832PROSTHETIC SCREWSDTR-SC112019-05-15
07290113356825PROSTHETIC SCREWSSMU-40232019-04-17
07290113352537PROSTHETIC SCREWSDSC-00202018-09-10
07290113352544PROSTHETIC SCREWSDSC-00302018-09-10
07290113352599PROSTHETIC SCREWSDSC-00402018-09-10
07290113352605PROSTHETIC SCREWSDSC-00502018-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290116154787Dental DrillsNORIS MEDICAL LTDDZA2026-07-09
07290116154794Diamond BurrsNORIS MEDICAL LTDDZA2026-07-09
088000702492151.2 Hex Angled Machine Screw DriverIzenimplant Co., Ltd.DZA2026-06-22
06932195393831DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
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06932195395071DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
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06932195395095DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395101DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395118DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395125DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10