FDA.reportPublic FDA data

KOMET Dental Diamond Instruments

Primary DI
E226021599A28
Brand
KOMET Dental Diamond Instruments
Company
Gebr. Brasseler GmbH & Co. KG
Model
5846KR.312.016.A2
Catalog number
5846KR.312.016
Published
2023-02-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
E226021599A21PrimaryHIBCC0
E226021599A28Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
317409001
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14053613286364Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.431S05.005.431S2026-10-01
14053613286395Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.433S05.005.433S2026-10-01
14053613286425Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.442S05.005.442S2026-10-01
14053613286449Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.451S05.005.451S2026-10-01
14053613286456Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.452S05.005.452S2026-10-01
14053613286470Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.453S05.005.453S2026-10-01
14053613286487Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.454S05.005.454S2026-10-01
14053613286494Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.445S05.005.445S2026-10-01
14053613286722Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.305S05.005.305S2026-10-01
14053613286777Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.005S05.005.005S2026-10-01
14053613286784Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.106S05.519.106S2026-10-01
14053613286791Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.113S05.519.113S2026-10-01
14053613286944Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.304S05.519.304S2026-10-01
14053613001493KOMET Surgical BurNC0303.004..M0NC0303.004.2023-01-31
E226000081AU1KOMET Dental Tungsten Carbide BursH1.313.018.AUH1.313.0182023-01-19
14053613298343KOMET Surgical BurS27261.501..M0S27261.501.2026-09-30
14053613298350KOMET Surgical BurS27262.501..M0S27262.501.2026-09-30
E226000077AU1KOMET Dental Tungsten Carbide BursH1.313.010.AUH1.313.0102023-01-19
E226100004991KOMET Dental Diamond InstrumentsS5878.314.016.A2S5878.314.0162023-02-01
14053613286630Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.201S05.005.201S2026-09-28

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