FDA.reportPublic FDA data

1.2 Hex Angled Machine Screw Driver

Primary DI
08800070249215
Brand
1.2 Hex Angled Machine Screw Driver
Company
Izenimplant Co., Ltd.
Model
HEADM1215
Published
2026-06-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
08800070249215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800070249215088000702492158800070249215

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
963328442
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
08800070203415ZENEX PLUS FixtureZPRM35082026-06-26
08800070203422ZENEX PLUS FixtureZPRM35102026-06-26
08800070203439ZENEX PLUS FixtureZPRM35112026-06-26
08800070203446ZENEX PLUS FixtureZPRM35132026-06-26
08800070230367ZENEX MULTI FixtureZMRW5006S2026-06-26
08800070230374ZENEX MULTI FixtureZMRW5506S2026-06-26
08800070230381ZENEX MULTI FixtureZMRW6006S2026-06-26
08800070230398ZENEX MULTI FixtureZMRW7006S2026-06-26
08800070229125ZENEX MULTI FixtureZMRW5007S2026-06-26
08800070229132ZENEX MULTI FixtureZMRW5008S2026-06-26
08800070229149ZENEX MULTI FixtureZMRW5010S2026-06-26
08800070229156ZENEX MULTI FixtureZMRW5011S2026-06-26
08800070229163ZENEX MULTI FixtureZMRW5013S2026-06-26
08800070229170ZENEX MULTI FixtureZMRW5015S2026-06-26
08800070229187ZENEX MULTI FixtureZMRW5507S2026-06-26
08800070229194ZENEX MULTI FixtureZMRW5508S2026-06-26
08800070229200ZENEX MULTI FixtureZMRW5510S2026-06-26
08800070229217ZENEX MULTI FixtureZMRW5511S2026-06-26
08800070229224ZENEX MULTI FixtureZMRW5513S2026-06-26
08800070229231ZENEX MULTI FixtureZMRW5515S2026-06-26

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
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
06932195395125DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395132DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10