MASTER-FIL

GUDID 00816526022088

Master-Fil BULKFILL Universal LC Composite

DENTONICS INC

Dental composite resin

• Primary Device ID: 00816526022088
• NIH Device Record Key: 6c4a5942-2f75-4ac8-bb65-70304bef93a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MASTER-FIL
• Version Model Number: 19-602
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816526022088 [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