Rotory Scaler Swivel Improvement Feature, Titan Sw

• 2 recalls, same reason

  • Ongoing Z-2177-2024 FDA Class II ·initiated 30 May 2024
  • Ongoing Z-2178-2024 FDA Class II ·initiated 30 May 2024

  Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury

510(k) Number

K881253 ↗

FDA Product Code

ELC

Device Class

Class II

Regulation

21 CFR Part 872.4850

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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