Duns Number:006385173
Device Description: ComfortSoft® is a high pressure cured, silicone-based soft lining material for long-term u ComfortSoft® is a high pressure cured, silicone-based soft lining material for long-term use in removable dentures. ComfortSoft® is suitable for all PMMA-based dentures, meets ISO 10139-2, and is a Shors A hardness Type A material.
Catalog Number
20011860
Brand Name
Preference Soft Denture Liner
Version/Model Number
Silicone Tube 12 oz.
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 06, 2019
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K140146
Product Code
EBI
Product Code Name
Resin, Denture, Relining, Repairing, Rebasing
Public Device Record Key
7d94894c-1517-408b-a631-356f6b01ff9d
Public Version Date
July 31, 2019
Public Version Number
4
DI Record Publish Date
September 02, 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 | 63 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 293 |
| U | Unclassified | 1 |