BONA-BITE

GUDID 05206569480023

Addition curing silicone bite registration material

DMP DENTAL INDUSTRY S.A.

Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material

• Primary Device ID: 05206569480023
• NIH Device Record Key: d0d6d715-ee6a-416c-add2-42e8ba62ca29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BONA-BITE
• Version Model Number: 50ml
• Company DUNS: 728534814
• Company Name: DMP DENTAL INDUSTRY S.A.
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +302299023041
• Email: info@dmpdental.com
• Phone: +302299023041
• Email: info@dmpdental.com
• Phone: +302299023041
• Email: info@dmpdental.com
• Phone: +302299023041
• Email: info@dmpdental.com
• Phone: +302299023041
• Email: info@dmpdental.com
• Phone: +302299023041
• Email: info@dmpdental.com
• Phone: +302299023041
• Email: info@dmpdental.com
• Phone: +302299023041
• Email: info@dmpdental.com
• Phone: +302299023041
• Email: info@dmpdental.com
• Phone: +302299023041
• Email: info@dmpdental.com
• Phone: +302299023041
• Email: info@dmpdental.com
• Phone: +302299023041
• Email: info@dmpdental.com
• Phone: +302299023041
• Email: info@dmpdental.com
• Phone: +302299023041
• Email: info@dmpdental.com
• Phone: +302299023041
• Email: info@dmpdental.com
• Phone: +302299023041
• Email: info@dmpdental.com
• Phone: +302299023041
• Email: info@dmpdental.com
• Phone: +302299023041
• Email: info@dmpdental.com
• Phone: +302299023041
• Email: info@dmpdental.com
• Phone: +302299023041
• Email: info@dmpdental.com
• Phone: +302299023041
• Email: info@dmpdental.com
• Phone: +302299023041
• Email: info@dmpdental.com
• Phone: +302299023041
• Email: info@dmpdental.com
• Phone: +302299023041
• Email: info@dmpdental.com
• Phone: +302299023041
• Email: info@dmpdental.com
• Phone: +302299023041
• Email: info@dmpdental.com
• Phone: +302299023041
• Email: info@dmpdental.com
• Phone: +302299023041
• Email: info@dmpdental.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05206569000214 [Primary]
GS1	05206569001310 [Package]; Contains: 05206569000214; Package: Box [32 Units]; In Commercial Distribution
GS1	05206569480016 [Package]; Contains: 05206569000214; Package: Box [2 Units]; In Commercial Distribution
GS1	05206569480023 [Package]; Contains: 05206569000214; Package: Box [4 Units]; In Commercial Distribution

FDA Product Code

• ELW: Material, Impression

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

Devices Manufactured by DMP DENTAL INDUSTRY S.A.

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• 05206569001747 - BRIGHT TEMPORARY C&B: 2020-09-17 Temporary Crown & Bridge composite
• 05206569001754 - BRIGHT TEMPORARY C&B: 2020-09-17 Temporary Crown & Bridge composite
• 05206569001761 - BRIGHT TEMPORARY C&B: 2020-09-17 Temporary Crown & Bridge composite
• 05206569001778 - BRIGHT TEMPORARY C&B: 2020-09-17 Temporary Crown & Bridge composite
• 05206569001785 - BRIGHT TEMPORARY C&B: 2020-09-17 Temporary Crown & Bridge composite
• 05206569001792 - BRIGHT TEMPORARY C&B: 2020-09-17 Temporary Crown & Bridge composite
• 05206569001839 - BRIGHT TEMPORARY C&B: 2020-09-17 Temporary Crown & Bridge composite