KOMET CeraDrill K210L19.204.028

GUDID E226033795A11

Gebr. Brasseler GmbH & Co. KG

Ceramic dental bur

• Primary Device ID: E226033795A11
• NIH Device Record Key: 8c6d21a3-3d43-4590-aa18-24f5b749f8c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KOMET CeraDrill
• Version Model Number: K210L19.204.028.A1
• Catalog Number: K210L19.204.028
• Company DUNS: 317409001
• Company Name: Gebr. Brasseler GmbH & Co. KG
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E226033795A11 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071352

FDA Product Code

• EJL: BUR, DENTAL

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[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 Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-01
• Device Publish Date: 2023-08-24

On-Brand Devices [KOMET CeraDrill]

• E226035212A11: K210L20.205.042.A1
• E226035211A11: K210L20.205.035.A1
• E226034900A11: K210L20.205.028.A1
• E226034899A11: K210L20.205.020.A1
• E226033794A11: K210L16.204.028.A1
• E226033793A11: K210L19.204.020.A1
• E226033792A11: K210L16.204.020.A1
• E226033795A11: K210L19.204.028.A1