510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K803269Substantially Equivalent

Capsule Dental Amalgam

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

K803269 is the FDA 510(k) clearance record for CAPSULE DENTAL AMALGAM, 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 K803269.

Clearance record

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