EDENTA

Primary DI
E312K861L104024101
Brand
EDENTA
Company
EDENTA ETABLISSEMENT
Model
K861L.104.024
Device description
K-Diamond HP
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

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
E312K861L1040241PrimaryHIBCC0
E312K861L104024101Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
448002915
Device count
3
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E3123661040121EDENTA366.104.0122022-02-03
E3123661040161EDENTA366.104.0162022-02-03
E3123681040231EDENTA368.104.023M368-023HP2022-02-03
E3123901040161EDENTA390.104.0162022-02-03
E3124896A1040801EDENTA4896A.104.0802022-02-03
E31253691040701EDENTA5369.104.0702022-02-03
E31258301040701EDENTA5830.104.0702022-02-03
E31258361040601EDENTA5836.104.0602022-02-03
E3125848L1040231EDENTA5848L.104.0232022-02-03
E31258561040231EDENTA5856.104.0232022-02-03
E31258561040401EDENTA5856.104.0402022-02-03
E31258601040601EDENTA5860.104.0602022-02-03
E31258621040601EDENTA5862.104.0602022-02-03
E31258931040471EDENTA5893.104.0472022-02-03
E31258931040601EDENTA5893.104.0602022-02-03
E31258961040801EDENTA5896.104.0802022-02-03
E31268011040351EDENTA6801.104.0352022-02-03
E31268361040551EDENTA6836.104.0552022-02-03
E31268411040371EDENTA6841.104.0372022-02-03
E3126842KR1040231EDENTA6842KR.104.0232022-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00304040199602Henry ScheinHENRY SCHEIN, INC.DZP2026-10-01
00304040199619Henry ScheinHENRY SCHEIN, INC.DZP2026-10-01
00304040199626Henry ScheinHENRY SCHEIN, INC.DZP2026-10-01
00304040199633Henry ScheinHENRY SCHEIN, INC.DZP2026-10-01
00304040199640Henry ScheinHENRY SCHEIN, INC.DZP2026-10-01
00304040199657Henry ScheinHENRY SCHEIN, INC.DZP2026-10-01
00304040199664Henry ScheinHENRY SCHEIN, INC.DZP2026-10-01
00304040199671Henry ScheinHENRY SCHEIN, INC.DZP2026-10-01
08404535036985Brasseler USAPeter Brasseler Holdings, LLCDZP2026-10-01
00304040199312Henry ScheinHENRY SCHEIN, INC.DZP2026-09-30
00304040199091Henry ScheinHENRY SCHEIN, INC.DZP2026-09-29
00304040199107Henry ScheinHENRY SCHEIN, INC.DZP2026-09-29
00304040199114Henry ScheinHENRY SCHEIN, INC.DZP2026-09-29
00304040199121Henry ScheinHENRY SCHEIN, INC.DZP2026-09-29
00304040199138Henry ScheinHENRY SCHEIN, INC.DZP2026-09-29
00304040199145Henry ScheinHENRY SCHEIN, INC.DZP2026-09-29
00304040199152Henry ScheinHENRY SCHEIN, INC.DZP2026-09-29
00304040199169Henry ScheinHENRY SCHEIN, INC.DZP2026-09-29
00304040199176Henry ScheinHENRY SCHEIN, INC.DZP2026-09-29
00304040199183Henry ScheinHENRY SCHEIN, INC.DZP2026-09-29
00304040199190Henry ScheinHENRY SCHEIN, INC.DZP2026-09-29
00304040199206Henry ScheinHENRY SCHEIN, INC.DZP2026-09-29
00304040199213Henry ScheinHENRY SCHEIN, INC.DZP2026-09-29
00304040199220Henry ScheinHENRY SCHEIN, INC.DZP2026-09-29
00304040199237Henry ScheinHENRY SCHEIN, INC.DZP2026-09-29
00304040199244Henry ScheinHENRY SCHEIN, INC.DZP2026-09-29
00304040199251Henry ScheinHENRY SCHEIN, INC.DZP2026-09-29
00304040199268Henry ScheinHENRY SCHEIN, INC.DZP2026-09-29
00304040199275Henry ScheinHENRY SCHEIN, INC.DZP2026-09-29
00304040199282Henry ScheinHENRY SCHEIN, INC.DZP2026-09-29