510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K840652Substantially Equivalent

Prism-Fine

Dentsply Intl., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840652 is the FDA 510(k) clearance record for PRISM-FINE, cleared for Dentsply Intl. on . FDA records list 291 510(k) clearances for Dentsply Intl., from to . As of , FDA records show no recalls naming K840652.

Clearance record

Decision date
Received
(169 days to decision)
Review panel
Unknown
Applicant
Dentsply Intl. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No