FDA.reportPublic FDA data

UNIMETRIC 0.8 MM Special penetration drill

Primary DI
J003C0212200208001
Brand
UNIMETRIC 0.8 MM Special penetration drill
Company
MAILLEFER INSTRUMENTS HOLDING Sàrl
Model
C021220020800
Catalog number
C021220020800
Device description
Endodontic Posts Drills
Published
2022-09-30
Public version status
Update
Distribution status
Not 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
J003C0212200208001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pin/post dental drill bitA shaft of metal, typically with a spiralled portion at the cutting end (a twist drill bit), intended to be attached to a motorized handpiece, or other power source, to create a precise round hole at the appropriate depth in teeth or bone of the oral cavity. This hole or slot is used to secure cast or preformed pins/posts for stabilizing and retaining operative dental appliances. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00N/A

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480538495
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J003PTGGPAST1Protaper Gold Conform FitPTGGPASTPTGGPAST2026-05-13
J003PTGGPF11Protaper Gold Conform FitPTGGPF1PTGGPF12026-05-13
J003PTGGPF21Protaper Gold Conform FitPTGGPF2PTGGPF22026-05-13
J003PTGGPF31Protaper Gold Conform FitPTGGPF3PTGGPF32026-05-13
J003PTGGPF41Protaper Gold Conform FitPTGGPF4PTGGPF42026-05-13
J003PTGGPF51Protaper Gold Conform FitPTGGPF5PTGGPF52026-05-13
J003PTNGPX21Protaper Next Conform FitPTNGPX2PTNGPX22026-05-13
J003PTNGPX31Protaper Next Conform FitPTNGPX3PTNGPX32026-05-13
J003PTNGPX41Protaper Next Conform FitPTNGPX4PTNGPX42026-05-13
J003PTNGPX51Protaper Next Conform FitPTNGPX5PTNGPX52026-05-13
J003PTUGPAST1Protaper Universal Conform FitPTUGPASTPTUGPAST2026-05-13
J003PTUGPF11Protaper Universal Conform FitPTUGPF1PTUGPF12026-05-13
J003PTUGPF21Protaper Universal Conform FitPTUGPF2PTUGPF22026-05-13
J003PTUGPF31Protaper Universal Conform FitPTUGPF3PTUGPF32026-05-13
J003PTUGPF41Protaper Universal Conform FitPTUGPF4PTUGPF42026-05-13
J003PTUGPF51Protaper Universal Conform FitPTUGPF5PTUGPF52026-05-13
J003PULGAST1Protaper Ultimate Conform FitPULGASTPULGAST2026-05-13
J003PULGF11Protaper Ultimate Conform FitPULGF1PULGF12026-05-13
J003PULGF21Protaper Ultimate Conform FitPULGF2PULGF22026-05-13
J003PULGF31Protaper Ultimate Conform FitPULGF3PULGF32026-05-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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