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510(k) K130959

AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GEL by Bioplax Limited — Product Code OLR

K130959 is an FDA 510(k) premarket notification submitted by Bioplax Limited for the device "AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GEL". The FDA issued a decision of Substantially Equivalent on April 4, 2014. The device falls under product code OLR (Oral Wound Dressing), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2014
Date Received
April 5, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oral Wound Dressing
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.

Other clearances for product code OLR

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  • K253816 — MuCover (proposed name) Oral Wound Dressing (May 21, 2026)
  • K253758 — Dental Cone; Dental Sponge (December 18, 2025)
  • K252425 — Silatrix Oral Gel (October 23, 2025)
  • K241283 — Elemental Granulate (January 3, 2025)
  • K230529 — HealiAid Dental Collagen Wound Dressing (November 22, 2023)
  • K221428 — PerioStom Dental Dressing (December 22, 2022)
  • K211851 — Ora-Aid (January 11, 2022)
  • K210211 — PuraStat-OM (October 8, 2021)
  • K203091 — MucoLock Oral Gel (February 12, 2021)

FDA data resources