510(k) · Cleared
ClearedOra-Aid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tbm Corporation · OLR Oral Wound Dressing
Cleared on Jan 11, 2022 as substantially equivalent to K110750 (Mis Implants Technologies, Ltd., 2011) after a 210-day review. Its family tree reaches back 2 generations to 2011. 1 later device descends from it.
- Decided
- Jan 11, 2022
- Review
- 210 days
- Class
- Class U
- Product code
- OLR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K103054 (2011). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK103054 PeriopatchIzun Pharmaceuticals Corporation · 2011
- 1 generation backK110750 PeriopatchMis Implants Technologies, Ltd. · 2011
- This deviceK211851 Ora-AidTbm Corporation · 2022
- Descendant · cites it directly · 0 of its ownK253816 MuCover (proposed name) Oral Wound DressingMoleculeX Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253816MuCover (proposed name) Oral Wound DressingMoleculeX Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K103054 | Periopatch | Izun Pharmaceuticals Corporation | 2011 | — |
| −1 | K110750 | Periopatch | Mis Implants Technologies, Ltd. | 2011 | — |
| 0 (this device) | K211851 | Ora-Aid | Tbm Corporation | 2022 | — |
| +1 | K253816 | MuCover (proposed name) Oral Wound Dressing | MoleculeX Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OLR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OLR device
- #1 K253758 Dental Cone; Dental Spongescore 13.2 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K110750 | PeriopatchSummary page 4…Predicate Device Manufacturer MIZ Implants Technologies Ltd. Device Name (Trade Name) PerioPatch 510(k) Number K110750 4. SUBJECT DEVICE DESCRIPTION Intra-oral Wound Dressing is a device comprised of an oral mucosa adhesive side and a protectio… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253816 | MuCover (proposed name) Oral Wound Dressing | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 10.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K253816 (MoleculeX Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OLR devicesOLR Oral Wound Dressing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · OLR
4so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · OLR
83in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLR
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OLR
5in 2025
MAUDE reports naming product code OLR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 93 | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 3 | 115 | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 2 | — | 1 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 3 | 83 | 0 | 5 |
| 2026 | 4 | 188 | 0 | — |
What is it indicated for?
Intra-oral Wound Dressing is intended for the management of all types of oral wounds, injuries and ulcerations of the gingival and oral mucosa, including stomatitis, minor chafing and traumatic ulcers, abrasions caused by braces and ill-fitting dentures, and lesions associated with oral surgery.
Intra-oral Wound Dressing operates to relieve pain by adhering to and protecting affected tissues from further irritation, thereby allowing healing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211851: Ora-Aid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211851
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026