FDA.reportPublic FDA data

KOMET CeraDrill

Primary DI
E226033794A11
Brand
KOMET CeraDrill
Company
Gebr. Brasseler GmbH & Co. KG
Model
K210L16.204.028.A1
Catalog number
K210L16.204.028
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071352000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071352000CERADRILLGebr. Brasseler GmbH & Co. KG2007-06-29EJL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E226033794A11PrimaryHIBCC0

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
1
DM 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
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
E226004255A21KOMET Dental Diamond Instruments813.314.010.A2813.314.0102023-01-31

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