510(k) · Cleared
ClearedHemcon Dental Dressing, 1 Dressing, 4 Dressing, 1 Dressing, Box of 12, 4 Dressing, Box of 12
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemcon, Inc. · OLR Oral Wound Dressing
Cleared on Jul 7, 2006 as substantially equivalent to K023298 (Hemcon, Inc., 2002) after a 144-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Jul 7, 2006
- Review
- 144 days
- Class
- Class U
- Product code
- OLR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K972914 (1997). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK972914 Syvek PatchMarine Polymer Technologies, Inc. · 1997
- 1 generation backK023298 Hemcon BandageHemcon, Inc. · 2002
- This deviceK060363 Hemcon Dental Dressing, 1 Dressing, 4 Dressing, 1 Dressing, Box of…Hemcon, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK221428 PerioStom Dental DressingForward Science, LLC · 2022
Most influential descendants
Showing 1 of 1 · See all- K221428PerioStom Dental DressingForward Science, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972914 | Syvek Patch | Marine Polymer Technologies, Inc. | 1997 | — |
| −1 | K023298 | Hemcon Bandage | Hemcon, Inc. | 2002 | — |
| 0 (this device) | K060363 | Hemcon Dental Dressing, 1 Dressing, 4 Dressing, 1 Dressing, Box of 12, 4… | Hemcon, Inc. | 2006 | — |
| +1 | K221428 | PerioStom Dental Dressing | Forward Science, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K023298 | Hemcon BandageSummary page 1…9053189 General Description: The HemCono Dental Dressing is identical in material, design and composition to the legally marketed HemCon®D Bandage (K023298, cleared 04 November 2002 with update K043050, cleared 03 June 2005). The only differences are the indication for use in the oral… | 2002 |
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 |
|---|---|---|---|
| K221428 | PerioStom Dental Dressing | 2022 | 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 9 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K221428 (Forward Science, LLC, 2022) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K023298.
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?
The HemCon® Dental Dressing is an oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060363 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060363: Hemcon Dental Dressing, 1 Dressing, 4 Dressing, 1 Dressing, Box of 12, 4 Dressing, Box of 12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060363
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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