Porcelain Fix

GUDID 07290115050448

Single package containing 2 syringes Porcelain Etch and 2 bottles Porcelain Silane

B.J.M. LABORATORIES LTD

Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent

• Primary Device ID: 07290115050448
• NIH Device Record Key: 499b78d5-c4e0-4301-b163-54b6a5284a1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Porcelain Fix
• Version Model Number: 400084
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

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	07290115050448 [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: 2023-11-30Single package containing 2 syringes Porcelain Etch and 2 bottles Porcelain Silane
• 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
• 07290115052886 - Auto-Cure Activator: 2023-11-30