FDA.reportPublic FDA data

NTI

Primary DI
E310M022B1
Brand
NTI
Company
NTI - Kahla GmbH Rotary Dental Instruments
Model
M022B
Catalog number
M022
Device description
NTI Converter Mandrel FG to HP
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
EJQWHEEL, POLISHING AGENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJQWheel, Polishing AgentDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E310M022B1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental laboratory mandrelA round shaft of substantial dimensions designed to be used in the dental laboratory to hold (locked into place) a rotating device, e.g., a grinding or polishing wheel, abrasive disk, circular saw, or a disk, stone or cup used for grinding or polishing; connectors and rotating endpieces may be included with the device. The mandrel will be placed into a laboratory dental handpiece or lathe that will rotate at high speed. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314810326
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
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
07630243641123KENDADent4You AGEJQ2025-09-17
07630243641130KENDADent4You AGEJQ2025-09-17
07630243641147KENDADent4You AGEJQ2025-09-17
07630243641154KENDADent4You AGEJQ2025-09-17
07630243641161KENDADent4You AGEJQ2025-09-17
07630243641178KENDADent4You AGEJQ2025-09-17
07630243641185KENDADent4You AGEJQ2025-09-17
07630243641192KENDADent4You AGEJQ2025-09-17
07630243641208KENDADent4You AGEJQ2025-09-17
07630243641215KENDADent4You AGEJQ2025-09-17
07630243641222KENDADent4You AGEJQ2025-09-17
07630243641239KENDADent4You AGEJQ2025-09-17
07630243641246KENDADent4You AGEJQ2025-09-17
07630243641253KENDADent4You AGEJQ2025-09-17
07630243641260KENDADent4You AGEJQ2025-09-17
07630243641277KENDADent4You AGEJQ2025-09-17
07630243641284KENDADent4You AGEJQ2025-09-17
07630243641291KENDADent4You AGEJQ2025-09-17
07630243641307KENDADent4You AGEJQ2025-09-17
07630243641314KENDADent4You AGEJQ2025-09-17
07630243641321KENDADent4You AGEJQ2025-09-17
07630243641338KENDADent4You AGEJQ2025-09-17
07630243641345KENDADent4You AGEJQ2025-09-17
07630243641352KENDADent4You AGEJQ2025-09-17
07630243641369KENDADent4You AGEJQ2025-09-17
07630243641376KENDADent4You AGEJQ2025-09-17
07630243641383KENDADent4You AGEJQ2025-09-17
07630243641390KENDADent4You AGEJQ2025-09-17
07630243641420KENDADent4You AGEJQ2025-09-17
07630243641437KENDADent4You AGEJQ2025-09-17