FDA 510(k) Applications for Medical Device Product Code "OLR"
(Oral Wound Dressing)

FDA 510(k) Number Applicant Device Name Decision Date
K210211 3-D Matrix, Inc. PuraStat-OM 10/08/2021
K221428 Forward Science LLC PerioStom Dental Dressing 12/22/2022
K203091 PCCA, Inc. MucoLock Oral Gel 02/12/2021
K202000 SA3, LLC Silatrix Oral Gel 11/20/2020
K193336 Synedgen, Inc. Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse 05/27/2020
K211851 TBM Corporation Ora-Aid 01/11/2022
K183436 TBM Corporation OraCure 09/18/2019


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