Duns Number:113170088
Device Description: Enhance™ L.C. is intended for use as a light cure adhesion booster to: fluorosed, hypocalc Enhance™ L.C. is intended for use as a light cure adhesion booster to: fluorosed, hypocalcified or deciduous enamel, saliva contaminated enamel, enamel where maximum adhesion is required,metal surfaces (gold, amalgam, stainless steel) and acrylic, porcelain or composite restorations.
Catalog Number
LCE6
Brand Name
Enhance
Version/Model Number
LCE6
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KLE
Product Code Name
Agent, Tooth Bonding, Resin
Public Device Record Key
c4b052e5-e845-44d2-b315-8400b0cdfea5
Public Version Date
October 29, 2018
Public Version Number
4
DI Record Publish Date
August 06, 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 | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 279 |