Porcelain Etch

GUDID 07290115050479

B.J.M. LABORATORIES LTD

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• Primary Device ID: 07290115050479
• NIH Device Record Key: a13bb972-3692-49a5-ac8e-a2aa7398a1cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Porcelain Etch
• Version Model Number: 400082
• Company DUNS: 514764117
• Company Name: B.J.M. LABORATORIES LTD
• Device Count: 1
• DM Exempt: false
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Total Volume: 2.4 Milliliter
• Total Volume: 2.4 Milliliter
• Total Volume: 2.4 Milliliter
• Total Volume: 2.4 Milliliter
• Total Volume: 2.4 Milliliter
• Total Volume: 2.4 Milliliter
• Total Volume: 2.4 Milliliter
• Total Volume: 2.4 Milliliter
• Total Volume: 2.4 Milliliter
• Total Volume: 2.4 Milliliter
• Total Volume: 2.4 Milliliter
• Total Volume: 2.4 Milliliter
• Total Volume: 2.4 Milliliter
• Total Volume: 2.4 Milliliter
• Total Volume: 2.4 Milliliter
• Total Volume: 2.4 Milliliter
• Total Volume: 2.4 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290115050479 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933766

FDA Product Code

• KLE: AGENT, TOOTH BONDING, RESIN

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-30
• Device Publish Date: 2023-11-22

Devices Manufactured by B.J.M. LABORATORIES LTD

• 07290115050141 - Multi Bond: 2023-11-30
• 07290115050158 - Multi Bond: 2023-11-30
• 07290115050370 - High-Q-Bond Adhesive Resin Cement Automix: 2023-11-30
• 07290115050448 - Porcelain Fix: 2023-11-30 Single package containing 2 syringes Porcelain Etch and 2 bottles Porcelain Silane
• 07290115050462 - Porcelain Silane: 2023-11-30
• 07290115050479 - Porcelain Etch: 2023-11-30
• 07290115050479 - Porcelain Etch: 2023-11-30
• 07290115052886 - Auto-Cure Activator: 2023-11-30