Eclipse® 905545
GUDID D0019055450
Dentsply International Inc.
Dental appliance fabrication material, resin| Primary Device ID | D0019055450 |
| NIH Device Record Key | 6313c911-2998-40aa-81bc-674167e3811d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Eclipse® |
| Version Model Number | Eclipse Bonding Agent |
| Catalog Number | 905545 |
| Company DUNS | 606173334 |
| Company Name | Dentsply International 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 | 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
Device Dimensions
| Weight | 180 Gram |
| Weight | 180 Gram |
| Weight | 180 Gram |
| Weight | 180 Gram |
| Weight | 180 Gram |
| Weight | 180 Gram |
| Weight | 180 Gram |
| Weight | 180 Gram |
| Weight | 180 Gram |
| Weight | 180 Gram |
| Weight | 180 Gram |
| Weight | 180 Gram |
| Weight | 180 Gram |
| Weight | 180 Gram |
| Weight | 180 Gram |
| Weight | 180 Gram |
| Weight | 180 Gram |
| Weight | 180 Gram |
| Weight | 180 Gram |
| Weight | 180 Gram |
| Weight | 180 Gram |
| Weight | 180 Gram |
| Weight | 180 Gram |
| Weight | 180 Gram |
| Weight | 180 Gram |
| Weight | 180 Gram |
| Weight | 180 Gram |
| Weight | 180 Gram |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D0019055450 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K051707
FDA Product Code
| KLE | AGENT, TOOTH BONDING, 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 | 5 |
| 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 |
Trademark Results [Eclipse]
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