RSVP Heavy Body 505HA1

GUDID D779505HA10

4.5g RSVP Heavy Viscosity A1

COSMEDENT, INC.

Dental crown/bridge resin, temporary Dental crown/bridge resin, temporary Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin

• Primary Device ID: D779505HA10
• NIH Device Record Key: 5fd76c31-b003-4b4a-8288-60d50149a8f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RSVP Heavy Body
• Version Model Number: 505HA1
• Catalog Number: 505HA1
• Company DUNS: 113911689
• Company Name: COSMEDENT, 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: 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D779505HA10 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980799

FDA Product Code

• EBG: Crown And Bridge, Temporary, Resin

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: 2016-09-22

On-Brand Devices [RSVP Heavy Body]

• D779505HS30: 4.5g RSVP Heavy Viscosity SB3
• D779505HA20: 4.5g RSVP Heavy Viscosity A2
• D779505HA10: 4.5g RSVP Heavy Viscosity A1