510(k) · Cleared
ClearedAftamed Mouthwash; Aftamed Gel; Aftamed Spray; Aftamed Shield; Aftamed Junior Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioplax Limited · OLR Oral Wound Dressing
Cleared on Apr 4, 2014 as substantially equivalent to K053342 (Ricerfarma Srl, 2007) after a 364-day review. Its family tree reaches back 5 generations to 1998.
- Decided
- Apr 4, 2014
- Review
- 364 days
- Class
- Class U
- Product code
- OLR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K983182 (1998). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK983182 Aloe Therapy Oral RinseCarrington Laboratories, Inc. · 1998
- 4 generations backK023155 Aloclair Oral RinseSinclair Pharmaceuticals, Ltd. · 2002
- 3 generations backK040950 Aloclair Oral GelSinclair Pharmaceuticals, Ltd. · 2004
- 2 generations backK042722 Aloclair Oral SpraySinclair Pharmaceuticals, Ltd. · 2005
- 1 generation backK053342 Gengigel MouthrinseRicerfarma Srl · 2007
- This deviceK130959 Aftamed Mouthwash; Aftamed Gel; Aftamed Spray; Aftamed Shield…Bioplax Limited · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K983182 | Aloe Therapy Oral Rinse | Carrington Laboratories, Inc. | 1998 | — |
| −4 | K023155 | Aloclair Oral Rinse | Sinclair Pharmaceuticals, Ltd. | 2002 | — |
| −3 | K040950 | Aloclair Oral Gel | Sinclair Pharmaceuticals, Ltd. | 2004 | — |
| −2 | K042722 | Aloclair Oral Spray | Sinclair Pharmaceuticals, Ltd. | 2005 | — |
| −1 | K053342 | Gengigel Mouthrinse | Ricerfarma Srl | 2007 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K053342 | Gengigel MouthrinseSummary page 8…outhwash. Classification Name: Dressing, Wound and Burn, Hydrogel w/Drug and/or Biologic Product Code: MGQ CFR Section: None Device Class: Unclassified Predicate Devices K053342 Gengigel Mouthwash Ricerfarma Srl Via Egadi, 7-20144 Milano, Jtaly Product Code-MGQ Device Description: Aftamed® Mouthwash adhe… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All OLR devicesOLR Oral Wound Dressing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Aftamed® Mouthwash provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, ill-fitting dentures or oral surgery. Aftamed® Gel provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including…
Read the full statement (204 words)
Aftamed® Mouthwash provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, ill-fitting dentures or oral surgery.
Aftamed® Gel provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, ill-fitting dentures or oral surgery.
Aftamed® Spray provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, ill-fitting dentures or oral surgery.
Aftamed® Shield provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, ill-fitting dentures or oral surgery.
Aftamed® Junior Gel provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, or oral surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130959 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130959: Aftamed Mouthwash; Aftamed Gel; Aftamed Spray; Aftamed Shield; Aftamed Junior Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130959
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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