FDA.reportPublic FDA data

Tapered Drill

Primary DI
08800076422810
Brand
Tapered Drill
Company
Truabutment Korea Co.,Ltd
Model
TGTD2812
Published
2025-12-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
08800076422810PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800076422810088000764228108800076422810

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
694514760
Device count
1
DM exempt
false
Premarket exempt
true
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800076417960Removal DriverRDR20S2026-03-19
08800076422872Tapered DrillTGTD35142025-12-23
08800076422889Tapered DrillTGTD42062025-12-23
08800076422902Tapered DrillTGTD42102025-12-23
08800076422919Tapered DrillTGTD42122025-12-23
08800076422926Tapered DrillTGTD42142025-12-23
08800076422735Tapered DrillTGTD22062025-12-16
08800076422742Tapered DrillTGTD22082025-12-16
08800076422759Tapered DrillTGTD22102025-12-16
08800076422766Tapered DrillTGTD22122025-12-16
08800076422773Tapered DrillTGTD22142025-12-16
08800076422780Tapered DrillTGTD28062025-12-16
08800076422797Tapered DrillTGTD28082025-12-16
08800076422803Tapered DrillTGTD28102025-12-16
08800076422827Tapered DrillTGTD28142025-12-16
08800076422834Tapered DrillTGTD35062025-12-16
08800076422841Tapered DrillTGTD35082025-12-16
08800076422858Tapered DrillTGTD35102025-12-16
08800076422865Tapered DrillTGTD35122025-12-16
08800076422933Straight DrillTGSD28082025-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290116660677Surgical DrillsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZA2026-07-12
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
06932195393848DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393855DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393879DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393886DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393909DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393916DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393923DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393930DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393954DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393961DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393985DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393992DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195394012DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395002DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395019DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395026DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395033DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395040DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395057DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395064DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395071DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395088DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
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