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Adjustable Therasnore

by Distar, Inc. 510(k)

Active United States

510(k) K973038

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK973038 Date12 Nov 1997ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LRK
Device Class
Class II
Regulation
21 CFR Part 872.5570
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Other devices from Distar, Inc.

  • Therasnore

    Class II