FDA.report

NTI

Primary DI
E310ERFTASST1
Brand
NTI
Company
NTI - Kahla GmbH Rotary Dental Instruments
Model
ERF-TASST
Catalog number
ERF-TASST
Device description
NTI T Endo Root Facer Asst Set
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

Related Records

Product Codes

CodeName
DZADRILL, DENTAL, INTRAORAL

Product Code Classifications

CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E310ERFTASST1PrimaryHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
314810326
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
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 DIBrandModelCatalogPublished
E310132008FFG2NTI132-008F-FGF132-0082022-01-01
E310132008SFFG2NTI132-008SF-FGSF132-0082022-01-01
E310133010FFG2NTI133-010F-FGF133-0102022-01-01
E310133010SFFG2NTI133-010SF-FGSF133-0102022-01-01
E310134014FFG2NTI134-014F-FGF134-0142022-01-01
E310134014SFFG2NTI134-014SF-FGSF134-0142022-01-01
E310135014FFG2NTI135-014F-FGF135-0142022-01-01
E310135014SFFG2NTI135-014SF-FGSF135-0142022-01-01
E3101602017HP1NTI160.2-017-HPD160.2-0172022-01-01
E310180150501NTI180.15.050EG204-0502022-01-01
E310180150701NTI180.15.070EG204-0702022-01-01
E310180150901NTI180.15.090EG204-0902022-01-01
E310180151101NTI180.15.110EG204-1102022-01-01
E310180151301NTI180.15.130EG204-1302022-01-01
E310180151501NTI180.15.150EG204-1502022-01-01
E31018015SO1NTI180.15.SOEG204-ASST2022-01-01
E310180190501NTI180.19.050EG205-0502022-01-01
E310180190701NTI180.19.070EG205-0702022-01-01
E310180190901NTI180.19.090EG205-0902022-01-01
E310180191101NTI180.19.110EG205-1102022-01-01

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