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Resolut Regenerative Material

by W. L. Gore & Associates, Inc. 3 variants

510(k) K932866

Resolut Regenerative Material is a Class II device made by W. L. Gore & Associates, Inc., cleared under FDA 510(k) K932866 on 28 Mar 1995, 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 NumberK932866 Date28 Mar 1995ClearedStatusActive

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  • Withdrawn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
LYC
Device class
Class II
Regulation
21 CFR Part 872.3930
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code LYC (Bone Grafting Material, Synthetic).

Other devices from W. L. Gore & Associates, Inc.

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