FDA.report

EDENTA

Primary DI
E312N7GS071
Brand
EDENTA
Company
EDENTA ETABLISSEMENT
Model
N7.GS.07
Device description
CAD/CAM diamond grinder
Published
2022-02-03
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
E312N7GS071PrimaryHIBCC0

GMDN Terms

TermDefinition
Diamond dental laboratory burA 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 laboratory handpiece that provides the rotation and that is intended for dental laboratory use only to cut hard structures, e.g., hard materials, plastics, porcelains and similar materials, during the fabrication of dental restorations. The diamond coating may be bonded to the different shaped bur heads by, e.g., electroplating, sintering, or moulded in various shapes with a rubber binding material. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
448002915
Device count
1
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
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
E3120001UM100101EDENTA0001UM-1002022-02-03
E3120001UM12101EDENTA0001UM-122022-02-03
E3120005UM100101EDENTA0005UM-1002022-02-03
E3120005UM12101EDENTA0005UM-122022-02-03
E3120023UM100101EDENTA0023UM-1002022-02-03
E3120023UM12101EDENTA0023UM-122022-02-03
E3120030RA100101EDENTA0030RA-1002022-02-03
E3120030RA12101EDENTA0030RA-122022-02-03
E3120031RA100101EDENTA0031RA-1002022-02-03
E3120031RA12101EDENTA0031RA-122022-02-03
E3120032RA100101EDENTA0032RA-1002022-02-03
E3120032RA12101EDENTA0032RA-122022-02-03
E3120033RA100101EDENTA0033RA-1002022-02-03
E3120033RA12101EDENTA0033RA-122022-02-03
E3120034RA100101EDENTA0034RA-1002022-02-03
E3120034RA12101EDENTA0034RA-122022-02-03
E3120035RA100101EDENTA0035RA-1002022-02-03
E3120035RA12101EDENTA0035RA-122022-02-03
E3120036RA100101EDENTA0036RA-1002022-02-03
E3120036RA12101EDENTA0036RA-122022-02-03

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
B868CV1600010Prodia SelectABRASIVE TECHNOLOGY, INC.DZP2026-02-18
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