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Silicone Elastomer Putty

by Crown Delta Corp.

510(k) K901991

Silicone Elastomer Putty 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) K901991 on 14 Sep 1990, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK901991 Date14 Sep 1990ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Devices cleared under K901991

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K901991
UDI-DISize and differences
Rolyan 081301654
Performance Health Supply, LLC
N/A / 08130165400885914040485 —On the market

Similar devices

Other devices filed under FDA product code MDA (Elastomer, Silicone, For Scar Management).

Other devices from Crown Delta Corp.

See all devices from Crown Delta Corp. →