KOMET CeraDrill K210L19.204.028

GUDID E226033795A11

Gebr. Brasseler GmbH & Co. KG

Ceramic dental bur Ceramic dental bur Ceramic dental bur Ceramic dental bur Ceramic dental bur Ceramic dental bur Ceramic dental bur Ceramic dental bur Ceramic dental bur Ceramic dental bur Ceramic dental bur Ceramic dental bur Ceramic dental bur Ceramic dental bur Ceramic dental bur Ceramic dental bur Ceramic dental bur 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