FDA.reportPublic FDA data

KOMET CeraDrill

Primary DI
E226033795A11
Brand
KOMET CeraDrill
Company
Gebr. Brasseler GmbH & Co. KG
Model
K210L19.204.028.A1
Catalog number
K210L19.204.028
Published
2023-08-24
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
E226033795A11PrimaryHIBCC0

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
E527041456DA1Diamond InstrumentsE368C.314.023.DAE368C.314.0232023-02-01
E527041496DA1Diamond InstrumentsE856C.314.012.DAE856C.314.0122023-02-01
E527045423DA1Diamond InstrumentsE859F.314.010.DAE859F.314.0102023-02-01
E226018226A31KOMET ReamerG180A.204.050.A3G180A.204.0502023-02-01
E226018228A31KOMET ReamerG180A.204.070.A3G180A.204.0702023-02-01
E226018230A31KOMET ReamerG180A.204.090.A3G180A.204.0902023-02-01
E226018232A31KOMET ReamerG180A.204.110.A3G180A.204.1102023-02-01
E527042995DA1KOMET Dental Diamond InstrumentsE392F.314.016.DAE392F.314.0162023-02-01
E527049101DA1ECOLINE Diamond InstrumentsE847F.314.016.DAE847F.314.0162023-08-09
E226018235A31KOMET ReamerG180.204.130.A3G180.204.1302023-02-01
14053613001998KOMET Surgical BurNC0612.004..M0NC0612.004.2023-01-31
14053613002322KOMET Surgical BurNS0101.012..M0NS0101.012.2023-01-31
14053613053232KOMET Surgical BurNS4101.009..M0NS4101.009.2023-02-01
14053613054222KOMET Surgical BurNS4001.027..M0NS4001.027.2023-02-01
14053613167298KOMET Surgical BurNS4002.027..M0NS4002.027.2023-02-01
14053613174227KOMET Surgical Saw BladeKMS2595.M62..M2KMS2595.M62.2023-02-01
14053613201060KOMET Surgical Saw BladeKM71125.C00..M0KM71125.C00.2023-09-29
14053613205525KOMET Surgical BurNC0186.016..M0NC0186.016.2023-02-01
14053613266892KOMET Surgical BurND1905.009..M0ND1905.009.2023-02-01
14053613266915KOMET Surgical BurND1903.004..M0ND1903.004.2023-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810149983191ROOTTTRATE LLCEJL2026-10-26
E0HM72C1170FG1n/aHager & Meisinger Gesellschaft mit beschränkter HaftungEJL2026-10-23
E0HM72C169FG1n/aHager & Meisinger Gesellschaft mit beschränkter HaftungEJL2026-10-23
08404535020779Brasseler USAPeter Brasseler Holdings, LLCEJL2026-10-20
08404535020809Brasseler USAPeter Brasseler Holdings, LLCEJL2026-10-20
08404535036985Brasseler USAPeter Brasseler Holdings, LLCEJL2026-10-01
00810194409387AiraAIRA, LLCEJL2026-08-25
00810194409431AiraAIRA, LLCEJL2026-08-25
00810194409448AiraAIRA, LLCEJL2026-08-25
00810194409462AiraAIRA, LLCEJL2026-08-25
00810194409486AiraAIRA, LLCEJL2026-08-25
00810194409523AiraAIRA, LLCEJL2026-08-25
00810194409547AiraAIRA, LLCEJL2026-08-25
00810194409554AiraAIRA, LLCEJL2026-08-25
00810194409585AiraAIRA, LLCEJL2026-08-25
00810194409592AiraAIRA, LLCEJL2026-08-25
00810194409608AiraAIRA, LLCEJL2026-08-25
00810194409622AiraAIRA, LLCEJL2026-08-25
00810194409646AiraAIRA, LLCEJL2026-08-25
00810194409776AiraAIRA, LLCEJL2026-08-25
00810194409837AiraAIRA, LLCEJL2026-08-25
00810194409912AiraAIRA, LLCEJL2026-08-25
00810194409943AiraAIRA, LLCEJL2026-08-25
00810194409950AiraAIRA, LLCEJL2026-08-25
00810194409981AiraAIRA, LLCEJL2026-08-25
00810226100022AiraAIRA, LLCEJL2026-08-25
00810226100060AiraAIRA, LLCEJL2026-08-25
00810226100138AiraAIRA, LLCEJL2026-08-25
00810226100213AiraAIRA, LLCEJL2026-08-25
00810226100268AiraAIRA, LLCEJL2026-08-25