FDA.reportPublic FDA data

NTI

Primary DI
E310856016SCFG0
Brand
NTI
Company
NTI - Kahla GmbH Rotary Dental Instruments
Model
856-016SC-FG
Catalog number
SC856-016G
Device description
NTI Gold Pack (50) 856-016-SC
Published
2022-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DZPINSTRUMENT, DIAMOND, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZPInstrument, Diamond, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E310856016SCFG3PrimaryHIBCC0
E310856016SCFG0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Diamond dental bur, reusableA rotary cutting device made of high-grade steel with the working end coated with particles of diamond, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
314810326
Device count
50
DM exempt
true
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
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
ESUN379P3140215Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2025-04-29
ESUN801C2040235Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2025-04-29
ESUN801F3140185Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801F3140235Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801F3140255Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801L3140145Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801L3140165Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801L3140185Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801L3140235Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801LC3140145Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801LC3140165Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801LC3140185Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801LC3140235Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801SC3140125Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801SC3140145Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801SC3140165Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801SC3140185Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801SC3140235Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801SC3140255Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801UF3140105Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801UF3140165Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801UF3140255Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801VF3140105Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801VF3140125Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801VF3140145Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801VF3140165Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801VF3140185Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801VF3140215Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801VF3140235Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801VF3140255Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23