FDA.reportPublic FDA data

KOMET Dental Diamond Instruments

Primary DI
E226004255A21
Brand
KOMET Dental Diamond Instruments
Company
Gebr. Brasseler GmbH & Co. KG
Model
813.314.010.A2
Catalog number
813.314.010
Published
2023-01-31
Public version status
Update
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
E226004255A21PrimaryHIBCC0
E226004255A28Unit 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
14053613048177KOMET Surgical Saw BladeKMS2510.56B..M2KMS2510.56B.2026-09-18
14053613286142Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.427S05.005.427S2026-09-18
14053613286159Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.428S05.005.428S2026-09-18
14053613286166Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.429S05.005.429S2026-09-18
14053613286180Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.437S05.005.437S2026-09-18
14053613286210Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.456S05.005.456S2026-09-18
14053613286234Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.402S05.005.402S2026-09-18
14053613286258Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.403S05.005.403S2026-09-18
14053613286265Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.411S05.005.411S2026-09-18
14053613286272Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.412S05.005.412S2026-09-18
14053613286296Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.413S05.005.413S2026-09-18
14053613286319Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.463S05.005.463S2026-09-18
14053613286333Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.426S05.005.426S2026-09-18
14053613286340Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.424S05.005.424S2026-09-18
14053613286517Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.421S05.005.421S2026-09-18
14053613286715Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.304S05.005.304S2026-09-18
14053613286821Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.210S05.519.210S2026-09-18
14053613286982Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.073S05.005.073S2026-09-18
14053613295717Reciprocating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II, UNIUM05.005.915S05.005.915S2026-09-18
14053613296431Bur, Round, round shank08227360082273602026-05-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630243660995Alpen DiamondsDent4You AGDZP2026-09-04
07630243661237Alpen DiamondsDent4You AGDZP2026-09-04
07630243662470Alpen DiamondsDent4You AGDZP2026-09-04
07630243662494Alpen DiamondsDent4You AGDZP2026-09-04
07630243662517Alpen DiamondsDent4You AGDZP2026-09-04
07630243662531Alpen DiamondsDent4You AGDZP2026-09-04
07630243662555Alpen DiamondsDent4You AGDZP2026-09-04
07630243662579Alpen DiamondsDent4You AGDZP2026-09-04
07630243662593Alpen DiamondsDent4You AGDZP2026-09-04
07630243662616Alpen DiamondsDent4You AGDZP2026-09-04
07630243662630Alpen DiamondsDent4You AGDZP2026-09-04
07630243662654Alpen DiamondsDent4You AGDZP2026-09-04
07630243662678Alpen DiamondsDent4You AGDZP2026-09-04
07630243662692Alpen DiamondsDent4You AGDZP2026-09-04
07630243662715Alpen DiamondsDent4You AGDZP2026-09-04
07630243662739Alpen DiamondsDent4You AGDZP2026-09-04
07630243662753Alpen DiamondsDent4You AGDZP2026-09-04
07630243662777Alpen DiamondsDent4You AGDZP2026-09-04
07630243662791Alpen DiamondsDent4You AGDZP2026-09-04
07630243662814Alpen DiamondsDent4You AGDZP2026-09-04
07630243662838Alpen DiamondsDent4You AGDZP2026-09-04
07630243662852Alpen DiamondsDent4You AGDZP2026-09-04
07630243662876Alpen DiamondsDent4You AGDZP2026-09-04
07630243662890Alpen DiamondsDent4You AGDZP2026-09-04
07630243662913Alpen DiamondsDent4You AGDZP2026-09-04
07630243662937Alpen DiamondsDent4You AGDZP2026-09-04
07630243662951Alpen DiamondsDent4You AGDZP2026-09-04
07630243662975Alpen DiamondsDent4You AGDZP2026-09-04
07630243662999Alpen DiamondsDent4You AGDZP2026-09-04
07630243663019Alpen DiamondsDent4You AGDZP2026-09-04