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Tradition P, Push Button Handpiece

by Midwest Dental Products Corp.

510(k) K963050

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK963050 Date11 Oct 1996ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0154-04 FDA Unclassified (pre-2012) initiated 14 Oct 2003
    • Terminated Z-0156-04 FDA Unclassified (pre-2012) initiated 14 Oct 2003
    • Terminated Z-0155-04 FDA Unclassified (pre-2012) initiated 14 Oct 2003

    Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time.

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  • Withdrawn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
EFB
Device Class
Class I
Regulation
21 CFR Part 872.4200
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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