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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K130959Substantially Equivalent

Aftamed Mouthwash; Aftamed Gel; Aftamed Spray; Aftamed Shield; Aftamed Junior Gel

Bioplax Limited, Bellingham WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130959 is the FDA 510(k) clearance record for AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GEL, cleared for Bioplax Limited on under FDA product code OLR (Oral Wound Dressing). FDA's definition for product code OLR reads: "Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ". FDA records list one 510(k) clearance for Bioplax Limited. As of , FDA records show no recalls naming K130959.

Clearance record

Decision date
Received
(364 days to decision)
Product code
OLR Oral Wound Dressing
Device class
Unclassified
Review panel
Unknown
Applicant
Bioplax Limited 472 S State St., #101, Bellingham WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OLR

Trailing 12 months
5 clearances under product code OLR in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OLR, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20261
August 20261
September 20260
October 20260