FDA.reportPublic FDA data

KOMET Dental Steel Burs

Primary DI
E226042312A11
Brand
KOMET Dental Steel Burs
Company
Gebr. Brasseler GmbH & Co. KG
Model
SF3.000..A1
Catalog number
SF3.000.
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
E226042312A11PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic dental scaling/debridement system handpiece tip, periodontal, reusableA removable endpiece intended to be attached to a pneumatic dental scaling/debridement system handpiece for the application of sonic vibrational energy (e.g., at a frequency of 6 kHz) to fragment and dislodge accretions or substances [e.g., dentine, enamel, plaque, calculus] from tooth and implant surfaces during dental cleaning/periodontal procedures (e.g., stripping, finishing); it is not intended for endodontic use. It is available in a variety of designs and may also be used for the removal of orthodontic cement. 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

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Primary DI, Brand, Company table
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08435389830436EXTRA SHORT DRILL; Ø3.5 MMBIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
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