Duns Number:606173334
Device Description: Contains: one 12-pack Eclipse Clear Upper Baseplate Resin (905006), one 12-pack Eclipse Cl Contains: one 12-pack Eclipse Clear Upper Baseplate Resin (905006), one 12-pack Eclipse Clear Lower Baseplate Resin (905012), one 12-pack Eclipse Resilient Resin (906080), one 12-pack Eclipse Original Upper Baseplate Resin (905001), one 12-pack Eclipse Original Lower Baseplate Resin (905007), one Eclipse Wax Remover (905620), one PermaSoft Soft Denture Liner Kit (N811100), and one Eclipse Bonding Agent Kit (905550), along with miscellaneous accessories (non-medical devices)
Catalog Number
905645
Brand Name
Eclipse®
Version/Model Number
Starter Package with Bonding Agent
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 05, 2022
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EBI
Product Code Name
RESIN, DENTURE, RELINING, REPAIRING, REBASING
Public Device Record Key
19406f30-371e-411b-9f33-66828f444889
Public Version Date
May 06, 2022
Public Version Number
5
DI Record Publish Date
September 21, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 57 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19532 |