Eclipse® 906080

GUDID D0019060800

Dentsply International Inc.

Dental appliance fabrication material, resin

• Primary Device ID: D0019060800
• NIH Device Record Key: d4bfe0dc-664c-4851-aee5-bd5a09ce732c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eclipse®
• Version Model Number: Heat & Seat® Resilient Resin
• Catalog Number: 906080
• Company DUNS: 606173334
• Company Name: Dentsply International Inc.
• Device Count: 12
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0019060800 [Primary]
HIBCC	D0019062808 [Unit of Use]

FDA Product Code

• EBI: RESIN, DENTURE, RELINING, REPAIRING, REBASING

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-11-10
• Device Publish Date: 2016-09-21

On-Brand Devices [Eclipse®]

• D0019061800: Heat & Seat® Resilient Resin
• D0019060800: Heat & Seat® Resilient Resin
• D0019056500: Contains: three 12-pack Eclipse Clear Upper Baseplate Resin (905006), three 12-pack Eclipse Clea
• D0019056450: Contains: one 12-pack Eclipse Clear Upper Baseplate Resin (905006), one 12-pack Eclipse Clear Lo
• D0019056200: Eclipse Wax Remover
• D0019055850: Contains: one 12-pack Eclipse Clear Upper Baseplate Resin (905006), one 12-pack Eclipse Clear Lo
• D0019055500: Bonding Agent Kit
• D0019055450: Eclipse Bonding Agent
• D0019052750: Contains: 11 12-pack boxes of Eclipse resins, Bonding Agent Kit, and miscellaneous accessories (
• D0019052610: Variety Pack
• D0019052600: Contains: 18 12-pack boxes of Eclipse resins, Bonding Agent Kit, and miscellaneous accessories (
• D0019050940: Light Reddish Pink
• D0019050930: Light Pink
• D0019050920: Original
• D0019050870: Original
• D0019050860: Clear
• D0019050830: Light Reddish Pink
• D0019050820: Light Pink
• D0019050810: Original
• D0019050800: Clear
• D0019050770: Light Reddish Pink
• D0019050760: Light Pink
• D0019050750: Original
• D0019050220: Dark Pink
• D0019050200: Light Reddish Pink
• D0019050190: Light Pink
• D0019050180: Original
• D0019050130: Original
• D0019050120: Clear
• D0019050110: Dark Pink
• D0019050090: Light Reddish Pink
• D0019050080: Light Pink
• D0019050070: Original
• D0019050060: Clear
• D0019050050: Dark Pink
• D0019050030: Light Reddish Pink
• D0019050020: Light Pink
• D0019050010: Original