510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K071617Substantially Equivalent

Oral Neutralizer

Oral Biotech LLC, Albany OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071617 is the FDA 510(k) clearance record for ORAL NEUTRALIZER, cleared for Oral Biotech on under FDA product code LFD (Saliva, Artificial). FDA records list one 510(k) clearance for Oral Biotech. As of , FDA records show no recalls naming K071617.

Clearance record

Decision date
Received
(128 days to decision)
Product code
LFD Saliva, Artificial
Device class
Unclassified
Review panel
Unknown
Applicant
Oral Biotech 812 Water St. NE, Albany OR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LFD

Trailing 12 months
1 clearance under product code LFD in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LFD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260