Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Ora-Aid

K-Number: K211851 · 2022-01-11

ApplicantTbm Corporation
Decision Date2022-01-11
Product CodeOLR
DecisionSubstantially Equivalent

Device Summary

Ora-Aid is a medical device manufactured by Tbm Corporation. It received FDA 510(k) clearance on 2022-01-11 under approval number K211851. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ora-Aid?

Ora-Aid is a medical device that received FDA 510(k) clearance on 2022-01-11. It is manufactured by Tbm Corporation. The 510(k) number is K211851.

When was Ora-Aid approved by the FDA?

Ora-Aid received FDA 510(k) clearance on 2022-01-11, under approval number K211851.

What company makes Ora-Aid?

Ora-Aid is manufactured by Tbm Corporation.

What is the FDA product code for Ora-Aid?

The FDA product code for Ora-Aid is OLR.

Other Devices by Tbm Corporation

K183436OraCure

Related Devices (Code: OLR)

K173196SUNTOUCH Dental DressingHuizhou Foryou Medical Devices Co., Ltd. K191987OrapeuticForward Science K183436OraCureTbm Corporation K202000Silatrix Oral GelSa3, LLC K193336Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound RinseSynedgen, Inc. K210211PuraStat-OM3-D Matrix, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑