FDA.report

NTI

Primary DI
E310836016SCFG2
Brand
NTI
Company
NTI - Kahla GmbH Rotary Dental Instruments
Model
836-016SC-FG
Catalog number
SC836-016
Device description
NTI Diamond SuperCoarse FG
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
DZPINSTRUMENT, DIAMOND, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
DZPInstrument, Diamond, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E310836016SCFG2PackageHIBCC5In Commercial Distribution
E310836016SCFG1PrimaryHIBCC0
E310836016SCFG0Unit of UseHIBCC0

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
5
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

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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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B868CV1600050Prodia SelectABRASIVE TECHNOLOGY, INC.DZP2026-02-18
B868CV1600060Prodia SelectABRASIVE TECHNOLOGY, INC.DZP2026-02-18
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D690W801008M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
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D690W801010M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
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D690W801014M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801016M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801018M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801021C0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801021M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801023M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801L016C0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801L016M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801L018M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
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D690W802016M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W805010M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W805014C0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W805014M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W805016M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W811031M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
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D690W830010M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16