510(k) · Cleared
ClearedHealiAid Dental Collagen Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maxigen Biotech, Inc. · OLR Oral Wound Dressing
Cleared on Nov 22, 2023 as substantially equivalent to K152600 (Collagen Matrix, Inc., 2016) after a 268-day review. Its family tree reaches back 10 generations to 1991.
- Decided
- Nov 22, 2023
- Review
- 268 days
- Class
- Class U
- Product code
- OLR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K910944 (1991). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK910944 MedifilBiocore · 1991
- 6 generations between
- 3 generations backK110388 Collacare DentalInnocoll Pharmaceuticals, Ltd. · 2011
- 2 generations backK122115 Collagen Dental Wound DressingsCollagen Matrix, Inc. · 2012
- 1 generation backK152600 Collagen Dental Wound DressingsCollagen Matrix, Inc. · 2016 · Recalled
- This deviceK230529 HealiAid Dental Collagen Wound DressingMaxigen Biotech, Inc. · 2023
Show all 10 generations
- Root · 10 generations backK910944 MedifilBiocore · 1991
- 9 generations backK030921 Collagen Topical Wound DressingCollagen Matrix, Inc. · 2003
- 8 generations backK040211 Modification to: Collagen Topical Wound DressingCollagen Matrix, Inc. · 2004
- 7 generations backK040558 Modification to: Collagen Topical Wound DressingCollagen Matrix, Inc. · 2004
- 6 generations backK061746 Collaguard, Model Fcia,Fcib,Fcic,and FcidInnocoll Pharmaceuticals · 2006
- 5 generations backK081782 CollievaInnocoll Pharmaceuticals · 2008
- 4 generations backK092805 Collagen SpongeInnocoll Pharmaceuticals · 2010
- 3 generations backK110388 Collacare DentalInnocoll Pharmaceuticals, Ltd. · 2011
- 2 generations backK122115 Collagen Dental Wound DressingsCollagen Matrix, Inc. · 2012
- 1 generation backK152600 Collagen Dental Wound DressingsCollagen Matrix, Inc. · 2016 · Recalled
- This deviceK230529 HealiAid Dental Collagen Wound DressingMaxigen Biotech, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K910944 | Medifil | Biocore | 1991 | — |
| −9 | K030921 | Collagen Topical Wound Dressing | Collagen Matrix, Inc. | 2003 | — |
| −8 | K040211 | Modification to: Collagen Topical Wound Dressing | Collagen Matrix, Inc. | 2004 | — |
| −7 | K040558 | Modification to: Collagen Topical Wound Dressing | Collagen Matrix, Inc. | 2004 | — |
| −6 | K061746 | Collaguard, Model Fcia,Fcib,Fcic,and Fcid | Innocoll Pharmaceuticals | 2006 | — |
| −5 | K081782 | Collieva | Innocoll Pharmaceuticals | 2008 | — |
| −4 | K092805 | Collagen Sponge | Innocoll Pharmaceuticals | 2010 | — |
| −3 | K110388 | Collacare Dental | Innocoll Pharmaceuticals, Ltd. | 2011 | — |
| −2 | K122115 | Collagen Dental Wound Dressings | Collagen Matrix, Inc. | 2012 | — |
| −1 | K152600 | Collagen Dental Wound Dressings | Collagen Matrix, Inc. | 2016 | 1 |
| 0 (this device) | K230529 | HealiAid Dental Collagen Wound Dressing | Maxigen Biotech, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K152600 | Collagen Dental Wound DressingsSummary page 5…marketed to which substantial equivalence is claimed Predicate devices: neoTape/neoPlug/neoCote Collagen Dental Wound Dressing (K152600) marketed by Collagen Matrix Inc. Reference devices: SurgiAid/HealiAid® Dental Coll… | 2016 |
| † | K100927 | Surgiaid | 2011 |
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 32 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 15 ancestors has a recall of any class.
- 1 other device also cites its predicate K152600.
How does its category compare?
All OLR devicesOLR Oral Wound Dressing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
HealiAid® Dental Collagen Wound Dressing is indicated for the management of oral wounds and sores, including:
1. Denture sores
2. Oral ulcers (non-infected or viral)
3. Periodontal surgical wounds
4. Extraction sites
5. Surgical wounds.
6. Traumatic wounds
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/K230529 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230529: HealiAid Dental Collagen Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230529
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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