510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K851841Substantially Equivalent

Imax Periotips

Stram Dental, Inc., Northbrook IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851841 is the FDA 510(k) clearance record for IMAX PERIOTIPS, cleared for Stram Dental, Inc. on . FDA records list one 510(k) clearance for Stram Dental, Inc. As of , FDA records show no recalls naming K851841.

Clearance record

Decision date
Received
(33 days to decision)
Review panel
Unknown
Applicant
Stram Dental, Inc. 655 Academy Dr., Northbrook IL
Third party review
No