KOMET CeraDrill K210L19.204.028

GUDID E226033795A11

Gebr. Brasseler GmbH & Co. KG

Ceramic dental bur
Primary Device IDE226033795A11
NIH Device Record Key8c6d21a3-3d43-4590-aa18-24f5b749f8c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameKOMET CeraDrill
Version Model NumberK210L19.204.028.A1
Catalog NumberK210L19.204.028
Company DUNS317409001
Company NameGebr. Brasseler GmbH & Co. KG
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE226033795A11 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EJLBUR, DENTAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[E226033795A11]

Moist Heat or Steam Sterilization


[E226033795A11]

Moist Heat or Steam Sterilization


[E226033795A11]

Moist Heat or Steam Sterilization


[E226033795A11]

Moist Heat or Steam Sterilization


[E226033795A11]

Moist Heat or Steam Sterilization


[E226033795A11]

Moist Heat or Steam Sterilization


[E226033795A11]

Moist Heat or Steam Sterilization


[E226033795A11]

Moist Heat or Steam Sterilization


[E226033795A11]

Moist Heat or Steam Sterilization


[E226033795A11]

Moist Heat or Steam Sterilization


[E226033795A11]

Moist Heat or Steam Sterilization


[E226033795A11]

Moist Heat or Steam Sterilization


[E226033795A11]

Moist Heat or Steam Sterilization


[E226033795A11]

Moist Heat or Steam Sterilization


[E226033795A11]

Moist Heat or Steam Sterilization


[E226033795A11]

Moist Heat or Steam Sterilization


[E226033795A11]

Moist Heat or Steam Sterilization


[E226033795A11]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-01
Device Publish Date2023-08-24

On-Brand Devices [KOMET CeraDrill]

E226035212A11K210L20.205.042.A1
E226035211A11K210L20.205.035.A1
E226034900A11K210L20.205.028.A1
E226034899A11K210L20.205.020.A1
E226033794A11K210L16.204.028.A1
E226033793A11K210L19.204.020.A1
E226033792A11K210L16.204.020.A1
E226033795A11K210L19.204.028.A1

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