510(k) · Cleared
ClearedAloclair Oral Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sinclair Pharmaceuticals, Ltd. · OLR Oral Wound Dressing
Cleared on Jun 21, 2004 as substantially equivalent to K023155 (Sinclair Pharmaceuticals, Ltd., 2002) and 1 other predicate after a 70-day review. Its family tree reaches back 2 generations to 1998. 3 later devices descend from it.
- Decided
- Jun 21, 2004
- Review
- 70 days
- Class
- Class U
- Product code
- OLR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K983182 (1998). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK983182 Aloe Therapy Oral RinseCarrington Laboratories, Inc. · 1998
- 1 generation backK023155 Aloclair Oral RinseSinclair Pharmaceuticals, Ltd. · 2002
- This deviceK040950 Aloclair Oral GelSinclair Pharmaceuticals, Ltd. · 2004
- Descendant · cites it directly · 2 of its ownK042722 Aloclair Oral SpraySinclair Pharmaceuticals, Ltd. · 2005
- Descendant · cites it directly · 1 of its ownK053342 Gengigel MouthrinseRicerfarma Srl · 2007
- Descendant · 2 generations on · 0 of its ownK130959 Aftamed Mouthwash; Aftamed Gel; Aftamed Spray; Aftamed Shield…Bioplax Limited · 2014
Most influential descendants
Showing 3 of 3 · See all- K042722Aloclair Oral SpraySinclair Pharmaceuticals, Ltd. · 2005 · cites it directly2descendants
- K053342Gengigel MouthrinseRicerfarma Srl · 2007 · cites it directly1descendant
- K130959Aftamed Mouthwash; Aftamed Gel; Aftamed Spray; Aftamed Shield; Aftamed Junior GelBioplax Limited · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983182 | Aloe Therapy Oral Rinse | Carrington Laboratories, Inc. | 1998 | — |
| −1 | K023155 | Aloclair Oral Rinse | Sinclair Pharmaceuticals, Ltd. | 2002 | — |
| 0 (this device) | K040950 | Aloclair Oral Gel | Sinclair Pharmaceuticals, Ltd. | 2004 | — |
| +1 | K042722 | Aloclair Oral Spray | Sinclair Pharmaceuticals, Ltd. | 2005 | — |
| +1 | K053342 | Gengigel Mouthrinse | Ricerfarma Srl | 2007 | — |
| +2 | K130959 | Aftamed Mouthwash; Aftamed Gel; Aftamed Spray; Aftamed Shield; Aftamed Junior… | Bioplax Limited | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 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? (2)
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 |
|---|---|---|---|
| * | K023155 | Aloclair Oral RinseSummary page 1…r Biologic 3. Devices to Which New Device is Substantially Equivalent: Sinclair Aloclair Oral Rinse cleared in 510(k) K023155 Sinclair Gelclair Concentrated Oral Gel cleared in 510(k) K013056 4. Device Description: ALOCLAIRTM ORAL GEL is a viscous gel f… | 2002 |
| * | K013056 | Gelclair Concentrated Oral GelSummary page 1…vices to Which New Device is Substantially Equivalent: Sinclair Aloclair Oral Rinse cleared in 510(k) K023155 Sinclair Gelclair Concentrated Oral Gel cleared in 510(k) K013056 4. Device Description: ALOCLAIRTM ORAL GEL is a viscous gel formulation, which is presented for over-the- counter use premixed i… | 2001 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K042722 (Sinclair Pharmaceuticals, Ltd., 2005) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K023155.
How does its category compare?
All OLR devicesOLR Oral Wound Dressing: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
SINCLAIR ALOCLAIRTM ORAL GEL is indicated for pain relief in all types of mouth lesions, aphthous stomatitis, aphthous ulcers, minor lesions, chafing and traumatic ulcers and abrasions caused by braces and ill fitting dentures and diffused aphthous ulcers. Aloclair Gel forms a protective film that covers lesions to provide rapid pain relief, and avoid further irritation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040950 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040950: Aloclair Oral Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040950
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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