Duns Number:067488114
Device Description: IMPLANT DENTISTRY: Fill and protect implant screw access holes and screw heads for abut IMPLANT DENTISTRY: Fill and protect implant screw access holes and screw heads for abutments and screw retained restorations from cement and composite. Protect threading, screws, and internal components of implants and abutments. When cured, Liquid Magic has a rubbery consistency and not adhesive to implant components making it easly removed by a probe or explorer. Use instead of teflon tape and cotton pellets.COSMETIC DENTISTRY: Isolate and contain restorative materials. Biomimetics - seal out unwanted materials. Block out, undercuts, and other similar uses for Dental and Lab procedures.
Catalog Number
47-1000
Brand Name
Liquid Magic - Resin Barrier
Version/Model Number
Kit - 3 mL Syr - 2 pk
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K151945
Product Code
EIE
Product Code Name
Dam, Rubber
Public Device Record Key
6024e104-59db-4ae3-9cc0-431c3627ecd8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 05, 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 | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 130 |