510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K820501Substantially Equivalent

Orx Dent-Aide Dental Emergency Kit

Dental Aide Products, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820501 is the FDA 510(k) clearance record for ORX DENT-AIDE DENTAL EMERGENCY KIT, cleared for Dental Aide Products on . FDA records list one 510(k) clearance for Dental Aide Products. As of , FDA records show no recalls naming K820501.

Clearance record

Decision date
Received
(53 days to decision)
Review panel
Unknown
Applicant
Dental Aide Products 803 N. Front St. Suite 3, Mchenry IL
Third party review
No