Vinyl Silicone Elastomer Material
510(k) K901990
Vinyl Silicone Elastomer Material is a medical device (FDA Class I; FDA product code MDA, Elastomer, Silicone, For Scar Management) made by Crown Delta Corp., cleared under FDA 510(k) K901990 on 14 Sep 1990, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK901990 | Date14 Sep 1990 | StatusActive |
Official records
- FDA 510(k) database K901990
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MDA
- Device class
- Class I
- Regulation
- 21 CFR Part 878.4025
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code MDA (Elastomer, Silicone, For Scar Management).
- NOVAGEL SILICONE GEL SHEETING by Brennen Medical, LLC
- SCAR HEAL by Specialty Systems, Inc.
- EVANESCE SCAR MANAGEMENT SYSTEM by Medical Scientific, Inc.
- CONFORM SHEETING, MODEL IGEL by Implantech Associates, Inc.
- NEWGEL AND NEWGEL PLUS E by Newmedical Technology, Inc.
- SCAREASE & SCAREASE ADHESIVE GEL by Scarease, Inc.
- SKIN 2 FORTE SILICONE SHEETING by United Hospital Technologies, Inc.
- TENDER TOUCH SILICONE GEL PADS by Capital Marketing Technologies, Inc.
- MEDICAL Z, S.A. MEDIGEL Z SCAR MANAGEMENT GEL by Medical Z, S.A.
- CURAD SCAR THERAPY by Beiersdorf, Inc.