510(k) · Cleared
ClearedSynvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synedgen, Inc. · OLR Oral Wound Dressing
Cleared on May 27, 2020 as substantially equivalent to K063148 (Merlin Group Dba Mcmerlin Dental Company, 2007) after a 177-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- May 27, 2020
- Review
- 177 days
- Class
- Class U
- Product code
- OLR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K953423 (1995). 6 ancestors in all, the oldest K933741 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK953423 Casrrasyn Oral Wound DressingCarrington Laboratories, Inc. · 1995
- 2 generations backK012126 The Salicept Oral PatchCarrington Laboratories, Inc. · 2001
- 1 generation backK063148 Sock IT! Oral Pain GelMerlin Group Dba Mcmerlin Dental Company · 2007
- This deviceK193336 Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound…Synedgen, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953423 | Casrrasyn Oral Wound Dressing | Carrington Laboratories, Inc. | 1995 | — |
| −2 | K012126 | The Salicept Oral Patch | Carrington Laboratories, Inc. | 2001 | — |
| −1 | K063148 | Sock IT! Oral Pain Gel | Merlin Group Dba Mcmerlin Dental Company | 2007 | — |
| 0 (this device) | K193336 | Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse | Synedgen, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 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 |
|---|---|---|---|
| * | K063148 | Sock IT! Oral Pain GelSummary page 4…g, wound and burn, hydrogel w/drug and/or biologic Classification: Unclassified Product Code: MGQ Primary Predicate Device: “Sock It!” Oral Pain Gel (K063148) Reference Predicate Devices: Gengigel Rinse (K053342) Moisyn (K173237) Device Description: Synvaza is an or… | 2007 |
| † | K053342 | Gengigel Mouthrinse | 2007 |
| † | K173237 | Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral… | 2018 |
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 25 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- None of the 6 ancestors has a recall.
- 3 other devices also cite its predicate K063148.
How does its category compare?
All OLR devicesOLR Oral Wound Dressing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Synvaza manages the pain in many types of oral wounds, mouth sores, injuries, and ulcers of the oral mucosa. It adheres to oral tissue and forms a protective barrier between the wound and further irritation and contamination. It provides the moist wound environment required for optimal wound healing. Manages pain associated with oral wounds, mouth sores, injuries and ulcers of the mouth such as: canker sores, irritation and traumatic ulcers; aphthous ulcers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193336 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193336: Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193336
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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