510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863834Substantially Equivalent

Evident Mark 2 Apex Locator

Pulpdent Corp. of America, Brookline MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863834 is the FDA 510(k) clearance record for EVIDENT MARK 2 APEX LOCATOR, cleared for Pulpdent Corp. of America on . FDA records list 6 510(k) clearances for Pulpdent Corp. of America, from to . As of , FDA records show no recalls naming K863834.

Clearance record

Decision date
Received
(129 days to decision)
Review panel
Unknown
Applicant
Pulpdent Corp. of America 75 Boylston St., Brookline MA
Third party review
No