FDA.reportPublic FDA data

KOMET Diamond Strip, Polishing Strip

Primary DI
E226049587A48
Brand
KOMET Diamond Strip, Polishing Strip
Company
Gebr. Brasseler GmbH & Co. KG
Model
DS60F.000..A4
Catalog number
DS60F.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
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EHMSTRIP, POLISHING AGENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHMStrip, Polishing AgentDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E226049587A41PrimaryHIBCC0
E226049587A48Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive strip, reusableA manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying (e.g., polishing, finishing, contouring, reducing) the surface of a tooth or restoration during a dental procedure. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
317409001
Device count
10
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
24053613265496Steinmann PinSP-80005-00-00SP-80005-00-002026-03-20
24053613296209Bur, tapered, round shank08227100082271002026-03-20
24053613295929Bur, Round, round shank08226780082267802026-03-11
24053613295936Bur, Round, round shank08226790082267902026-03-11
24053613296131Bur, Round, round shank08227000082270002026-03-11
24053613296193Bur, tapered, round shank08227090082270902026-03-11
24053613296803Bur, Round, round shank08227750082277502026-03-11
24053613297121Bur, cylindrical, round shank08228070082280702026-03-11
24053613297190Bur, Egg / egg shaped, round shank08228140082281402026-03-11
24053613297206Bur, Egg / egg shaped, round shank08228150082281502026-03-11
24053613297220Bur, Round, round shank08228170082281702026-03-11
04053613298315Guide Pin Smooth800-05-215800-05-2152026-03-11
84053613294535Guide Pin Smooth800-05-215800-05-2152026-01-30
24053613295721Shannon Recta X-LargaG01 S5330G01 S53302026-01-23
24053613284978Saw Blade5109-098-0435109-098-0432022-12-08
E226048483R18KOMET Root Canal Files17331.654.012.R117331.654.0122026-01-13
14053613294581Tech Ancillary Pack150-00-002150-00-0022026-01-08
24053613294557Guide Drill Pin800-02-508800-02-5082026-01-06
14053613294574Tech Knee Pack150-00-001150-00-0012026-01-06
E226007158R18KOMET Root Canal Files17321.654.006.R117321.654.0062025-12-10

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Primary DI, Brand, Company table
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