OraCure— 510(k) K183436

Name: FDA 510(k) clearance K183436
Creator: U.S. Food and Drug Administration
Published: 2019-09-18

Substantially Equivalent

Tbm Corporation

FDA 510(k) clearance K183436 for OraCure, Substantially Equivalent on 2019-09-18. Applicant: Tbm Corporation. Device class: Unclassified.

Clearance details

Applicant: Tbm Corporation
Product code: Code OLR
Device class: Unclassified
Advisory panel: Unknown
Date received: 2018-12-11
Decision date: 2019-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gwangju, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLR

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K260120 — NaturaJel Oral Wound Care Kit2026-08-05
K251908 — Emanate Tray2026-07-29
K260126 — Curajel Oral Gel2026-06-15
K253816 — MuCover (proposed name) Oral Wound Dressing2026-05-21
K253758 — Dental Cone; Dental Sponge2025-12-18

More clearances from Tbm Corporation

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K211851 — Ora-Aid2022-01-11

Adverse events under product code OLR

product code OLR

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.