FDA.report

NTI

Primary DI
E310FS3FX0
Brand
NTI
Company
NTI - Kahla GmbH Rotary Dental Instruments
Model
FS3-FX
Catalog number
FS3-FX
Device description
NTI Serrated Diamond Strip 3.75mm - F
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
E310FS3FX1PrimaryHIBCC0
E310FS3FX0Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental abrasive strip, reusableA manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying (e.g., polishing, finishing, contouring, reducing) the surface of a tooth or restoration during a dental procedure. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
314810326
Device count
10
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 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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Primary DIBrandCompanyProduct codePublished
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B868CV1600020Prodia SelectABRASIVE TECHNOLOGY, INC.DZP2026-02-18
B868CV1600030Prodia SelectABRASIVE TECHNOLOGY, INC.DZP2026-02-18
B868CV1600040Prodia SelectABRASIVE TECHNOLOGY, INC.DZP2026-02-18
B868CV1600050Prodia SelectABRASIVE TECHNOLOGY, INC.DZP2026-02-18
B868CV1600060Prodia SelectABRASIVE TECHNOLOGY, INC.DZP2026-02-18
D690W368021M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801008M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801009M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801010M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801012M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
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
D690W801L021M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W802014M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
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
D690W830008M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W830010M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16