FDA.reportPublic FDA data

KOMET Abrasive Instruments

Primary DI
E226039397A11
Brand
KOMET Abrasive Instruments
Company
Gebr. Brasseler GmbH & Co. KG
Model
9618EF.204.030.A1
Catalog number
9618EF.204.030
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
EHLPOINT, ABRASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHLPoint, AbrasiveDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E226039397A11PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive point, reusableA rotary endpiece designed to be attached to a dental power tool handpiece to produce an abrasive rotation typically for polishing and smoothing natural or restorative dental materials (e.g., crown) during a dental procedure. Also referred to as a polisher, it is available in various forms (e.g., conical), sizes, and materials [e.g., silicone, rubber, metal, diamond, silicon carbide, aluminium oxide]. 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
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
14053613296431Bur, Round, round shank08227360082273602026-05-04
14053613296646Bur, Round, round shank08227570082275702026-05-04
14053613295892Bur, Egg / egg shaped, round shank08227310082273102026-04-28
14053613296004Bur, Round, round shank08226860082268602026-04-28
14053613296325Bur, cylindrical, round shank08227240082272402026-04-28
14053613296363Bur, Bud / bud shaped, round shank08227280082272802026-04-28
14053613296455Bur, Round, round shank08227380082273802026-04-28
14053613296639Bur, Round, round shank08227560082275602026-04-28
14053613296684Twist drill, round shank08227620082276202026-04-28
14053613297438Bur, Round, round shank08228390082283902026-04-28
14053613297469Bur, Round, round shank08226770082267702026-04-28
14053613296561Bur, Round, round shank08227490082274902026-04-24
14053613296707Twist drill, round shank08227640082276402026-04-24
14053613295830Bur, Round, round shank08223830082238302026-04-21
14053613295878Bur, Round, round shank08226760082267602026-04-21
14053613295885Bur, Egg / egg shaped, round shank08227060082270602026-04-21
14053613295946Bur, Round, round shank08226800082268002026-04-21
14053613295953Bur, Round, round shank08226810082268102026-04-21
14053613295984Bur, Round, round shank08226840082268402026-04-21
14053613296035Bur, Round, round shank08226890082268902026-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07897990301155PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990301209PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990301216PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399756PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399763PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399770PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399787PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399794PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399800PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399817PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399824PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399831PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399848PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399855PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399862PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399886PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399893PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399909PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399916PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399923PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399930PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399947PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399954PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
08404535025101Brasseler USAPeter Brasseler Holdings, LLCEHL2026-05-11
07630049901094Diacomp flame, pu: 6 pcsDiaswiss SAEHL2023-10-02
07630049901773Diabrush cup, pu: 2 pcsDiaswiss SAEHL2023-10-02
07630049984073Diaceram 2-step cup, pu: 6 pcsDiaswiss SAEHL2023-10-02
07630049984554Diabrownies flame, pu: 6 pcsDiaswiss SAEHL2023-10-02
07630049984578Diabrownies cup, pu: 6 pcsDiaswiss SAEHL2023-10-02
07630049984592Diabrownies flame, pu: 6 pcsDiaswiss SAEHL2023-10-02