FDA.reportPublic FDA data

NTI

Primary DI
E310H269GK016FGXL1
Brand
NTI
Company
NTI - Kahla GmbH Rotary Dental Instruments
Model
H269GK-016-FGXL
Catalog number
H269GK-FGSG
Device description
NTI 269GK Endo Carbide
Published
2022-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EJLBUR, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E310H269GK016FGXL1PrimaryHIBCC0
E310H269GK016FGXL0Unit of UseHIBCC0

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
314810326
Device count
3
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E310368023MHP1NTI368-023M-HPM368-023HP2022-01-01
E310379023MHPA1NTI379-023M-HPAM379-023HPA2022-01-01
E310801012MHP1NTI801-012M-HPM801-012HP2022-01-01
E310801014MHP1NTI801-014M-HPM801-014HP2022-01-01
E310801016MHP1NTI801-016M-HPM801-016HP2022-01-01
E310801018MHP1NTI801-018M-HPM801-018HP2022-01-01
E310801023CHP1NTI801-023C-HPC801-023HP2022-01-01
E310801023MHP1NTI801-023M-HPM801-023HP2022-01-01
E310801029CHP1NTI801-029C-HPC801-029HP2022-01-01
E310801029MHP1NTI801-029M-HPM801-029HP2022-01-01
E310801035MHP1NTI801-035M-HPM801-035HP2022-01-01
E310805012CHP1NTI805-012C-HPC805-012HP2022-01-01
E310805012MHP1NTI805-012M-HPM805-012HP2022-01-01
E310805014MHP1NTI805-014M-HPM805-014HP2022-01-01
E310805016MHP1NTI805-016M-HPM805-016HP2022-01-01
E310805018MHP1NTI805-018M-HPM805-018HP2022-01-01
E310805021MHP1NTI805-021M-HPM805-021HP2022-01-01
E310805023MHP1NTI805-023M-HPM805-023HP2022-01-01
E310805040MHP1NTI805-040M-HPM805-040HP2022-01-01
E310807016MHP1NTI807-016M-HPM807-016HP2022-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08404535036985Brasseler USAPeter Brasseler Holdings, LLCEJL2026-10-01
00810194409387AiraAIRA, LLCEJL2026-08-25
00810194409431AiraAIRA, LLCEJL2026-08-25
00810194409448AiraAIRA, LLCEJL2026-08-25
00810194409462AiraAIRA, LLCEJL2026-08-25
00810194409486AiraAIRA, LLCEJL2026-08-25
00810194409523AiraAIRA, LLCEJL2026-08-25
00810194409547AiraAIRA, LLCEJL2026-08-25
00810194409554AiraAIRA, LLCEJL2026-08-25
00810194409585AiraAIRA, LLCEJL2026-08-25
00810194409592AiraAIRA, LLCEJL2026-08-25
00810194409608AiraAIRA, LLCEJL2026-08-25
00810194409622AiraAIRA, LLCEJL2026-08-25
00810194409646AiraAIRA, LLCEJL2026-08-25
00810194409776AiraAIRA, LLCEJL2026-08-25
00810194409837AiraAIRA, LLCEJL2026-08-25
00810194409912AiraAIRA, LLCEJL2026-08-25
00810194409943AiraAIRA, LLCEJL2026-08-25
00810194409950AiraAIRA, LLCEJL2026-08-25
00810194409981AiraAIRA, LLCEJL2026-08-25
00810226100022AiraAIRA, LLCEJL2026-08-25
00810226100060AiraAIRA, LLCEJL2026-08-25
00810226100138AiraAIRA, LLCEJL2026-08-25
00810226100213AiraAIRA, LLCEJL2026-08-25
00810226100268AiraAIRA, LLCEJL2026-08-25
00810226100275AiraAIRA, LLCEJL2026-08-25
00810226100572AiraAIRA, LLCEJL2026-08-25
00810226100985AiraAIRA, LLCEJL2026-08-25
00810226101043AiraAIRA, LLCEJL2026-08-25
00810226101050AiraAIRA, LLCEJL2026-08-25