FDA.reportPublic FDA data

KOMET Dental Ceramic Burs

Primary DI
E226039955A21
Brand
KOMET Dental Ceramic Burs
Company
Gebr. Brasseler GmbH & Co. KG
Model
K1SM.204.016.A2
Catalog number
K1SM.204.016
Published
2023-02-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EJLBUR, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E226039955A21PrimaryHIBCC0
E226039955A28Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ceramic dental burA rotary cutting device, the working end of which is made from ceramic, designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth and bone. 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
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14053613295632Reciprocating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II, UNIUM05.005.905S05.005.905S2026-10-20
14053613295656Reciprocating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II, UNIUM05.005.907S05.005.907S2026-10-20
14053613286692Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.301S05.005.301S2026-10-19
14053613286975Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.072S05.005.072S2026-10-19
14053613286999Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.074S05.005.074S2026-10-19
14053613287002Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.075S05.005.075S2026-10-19
14053613287019Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.302S05.005.302S2026-10-19
14053613286562Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.501S05.005.501S2026-10-14
14053613286654Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.202S05.005.202S2026-10-14
14053613286906Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.190S05.519.190S2026-10-14
14053613298657KOMET GUIDE PIN/SCREWGP004.076.030.M4GP004.076.0302026-10-14
14053613286609Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.103S05.005.103S2026-10-13
14053613298275Reciprocating Saw Blade for ConMed®/Linvatec® Hall®AR-400-203AR-400-2032026-10-13
14053613298282Reciprocating Saw Blade for ConMed®/Linvatec® Hall®AR-400-204AR-400-2042026-10-13
14053613286579Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.101S05.005.101S2026-10-09
14053613286685Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.205S05.005.205S2026-10-09
14053613286739Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.001S05.005.001S2026-10-09
14053613286753Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.003S05.005.003S2026-10-09
14053613298336Pin DriverIN-20500IN-205002026-10-09
14053613286371Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.432S05.005.432S2026-10-07

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Primary DI, Brand, Company table
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