510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K837382Substantially Equivalent

Optison Ultrasonic Scaler

KaVo Dental Technologies, LLC, Charlotte NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K837382 is the FDA 510(k) clearance record for OPTISON ULTRASONIC SCALER, cleared for Pelton & Crane Co. on . FDA records list 21 510(k) clearances for KaVo Dental Technologies, LLC, from to . As of , FDA records show no recalls naming K837382.

Clearance record

Decision date
Received
(63 days to decision)
Review panel
Unknown
Applicant
Pelton & Crane Co. 200 Clanton Rd., Charlotte NC
Third party review
No