FDA.reportPublic FDA data

A. Titan Instruments

Primary DI
00841685101961
Brand
A. Titan Instruments
Company
A. TITAN INSTRUMENTS, INC.
Model
XT 160
Device description
Premium Burr Block for drills and 4 sizes of screws
Published
2023-01-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841685101961PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841685101961008416851019618416851019610841685101961

GMDN Terms#

Term, Definition table
TermDefinition
Dental drill bit extensionA device intended to be attached to the shaft of a normal dental drill bit in order to lengthen it, providing greater accessibility and/or drilling capacity during a dental procedure. It is typically made of a high-grade metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Regulatory Flags#

DUNS number
037738874
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841685104207A. Titan InstrumentsRubber Tips2023-01-25
00841685104368A. Titan InstrumentsPowder2023-01-25
00841685111373A. Titan Instruments1000 (KIT)2023-01-25
00841685111571A. Titan InstrumentsK-3632023-01-20
00841685111588A. Titan InstrumentsK-3692023-01-20
00841685103453A. Titan InstrumentsT0652023-01-25
00841685112561A. Titan InstrumentsJAC 1S-2S UL2023-08-09
00841685112523A. Titan InstrumentsAMLB-12023-06-28
00841685112530A. Titan InstrumentsAMLB-22023-06-28
00841685112547A. Titan InstrumentsAMLBL-12023-06-28
00841685112554A. Titan InstrumentsAMLBL-22023-06-28
00841685108724A. Titan InstrumentsMB-12023-01-25
00841685112363A. Titan InstrumentsAMLC-42023-04-05
00841685112370A. Titan InstrumentsAMMC-32023-04-05
00841685112387A. Titan InstrumentsAMMC-72023-04-05
00841685112394A. Titan InstrumentsAMMC-102023-04-05
00841685112400A. Titan InstrumentsAMMC-112023-04-05
00841685112417A. Titan InstrumentsAMMC-122023-04-05
00841685112424A. Titan InstrumentsAMMC-132023-04-05
00841685112431A. Titan InstrumentsAMMC-142023-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701045246398KONTACTBIOTECH DENTALNDP2026-10-26
03701045279471KONTACTBIOTECH DENTALNDP2026-10-26
03701045279488KONTACTBIOTECH DENTALNDP2026-10-26
03701045279495KONTACTBIOTECH DENTALNDP2026-10-26
03701045279501KONTACTBIOTECH DENTALNDP2026-10-26
03701045279518KONTACTBIOTECH DENTALNDP2026-10-26
03701045279525KONTACTBIOTECH DENTALNDP2026-10-26
03701045279532KONTACTBIOTECH DENTALNDP2026-10-26
03701045279549KONTACTBIOTECH DENTALNDP2026-10-26
03701045279556KONTACTBIOTECH DENTALNDP2026-10-26
03701045279563KONTACTBIOTECH DENTALNDP2026-10-26
03701045279570KONTACTBIOTECH DENTALNDP2026-10-26
03701045279587KONTACTBIOTECH DENTALNDP2026-10-26
03701045279594KONTACTBIOTECH DENTALNDP2026-10-26
03701045279600KONTACTBIOTECH DENTALNDP2026-10-26
03701045279617KONTACTBIOTECH DENTALNDP2026-10-26
03701045279624KONTACTBIOTECH DENTALNDP2026-10-26
03701045279631KONTACTBIOTECH DENTALNDP2026-10-26
03701045279648KONTACTBIOTECH DENTALNDP2026-10-26
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