Master-Fil

GUDID 00816526022095

Master-Fil BULKFILL Universal LC Composite 20 X 0.25 gm capsules

DENTONICS INC

Dental composite resin

• Primary Device ID: 00816526022095
• NIH Device Record Key: f1b610e9-2fc3-4994-ae30-0567ce39d7ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Master-Fil
• Version Model Number: 19-602-C
• Company DUNS: 186285342
• Company Name: DENTONICS INC
• 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: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 704-238-0245
• Email: sales@dentonics.com
• Phone: 704-238-0245
• Email: sales@dentonics.com
• Phone: 704-238-0245
• Email: sales@dentonics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816526022095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K832781

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-05

On-Brand Devices [Master-Fil]

• 00816526022095: Master-Fil BULKFILL Universal LC Composite 20 X 0.25 gm capsules
• 00816526022088: Master-Fil BULKFILL Universal LC Composite