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510(k) K211851

Ora-Aid by Tbm Corporation — Product Code OLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2022
Date Received
June 15, 2021
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 by Tbm Corporation

  • K183436 — OraCure (September 18, 2019)

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  • K202000 — Silatrix Oral Gel (November 20, 2020)
  • K193336 — Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse (May 27, 2020)
  • K191987 — Orapeutic (November 27, 2019)