510(k) · Cleared
ClearedCollacare Dental
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innocoll Pharmaceuticals, Ltd. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Aug 9, 2011 as substantially equivalent to K092805 (Innocoll Pharmaceuticals, 2010) and 1 other predicate after a 180-day review. Its family tree reaches back 7 generations to 1991. 6 later devices descend from it.
- Decided
- Aug 9, 2011
- Review
- 180 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K910944 (1991). 12 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK910944 MedifilBiocore · 1991
- 6 generations backK030921 Collagen Topical Wound DressingCollagen Matrix, Inc. · 2003
- 5 generations backK040211 Modification to: Collagen Topical Wound DressingCollagen Matrix, Inc. · 2004
- 4 generations backK040558 Modification to: Collagen Topical Wound DressingCollagen Matrix, Inc. · 2004
- 3 generations backK061746 Collaguard, Model Fcia,Fcib,Fcic,and FcidInnocoll Pharmaceuticals · 2006
- 2 generations backK081782 CollievaInnocoll Pharmaceuticals · 2008
- 1 generation backK092805 Collagen SpongeInnocoll Pharmaceuticals · 2010
- This deviceK110388 Collacare DentalInnocoll Pharmaceuticals, Ltd. · 2011
- Descendant · cites it directly · 5 of its ownK122115 Collagen Dental Wound DressingsCollagen Matrix, Inc. · 2012
- Descendant · 2 generations on · 2 of its ownK152600 Collagen Dental Wound DressingsCollagen Matrix, Inc. · 2016 · Recalled
- Descendant · cites it directly · 1 of its ownK133290 Collacare DentalInnocoll Pharmaceuticals · 2014
- Descendant · 2 generations on · 0 of its ownK253758 Dental Cone; Dental SpongeMedizin Produkte Neustadt GmbH (Mpn) · 2025
- Descendant · 3 generations on · 0 of its ownK243071 Bovine Dermis Collagen Dermal MatrixCollagen Matrix, Inc. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K122115Collagen Dental Wound DressingsCollagen Matrix, Inc. · 2012 · cites it directly5descendants
- K152600Collagen Dental Wound DressingsCollagen Matrix, Inc. · 2016 · 2 generations on2descendants
- K133290Collacare DentalInnocoll Pharmaceuticals · 2014 · cites it directly1descendant
- K253758Dental Cone; Dental SpongeMedizin Produkte Neustadt GmbH (Mpn) · 2025 · 2 generations on0descendants
- K243071Bovine Dermis Collagen Dermal MatrixCollagen Matrix, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K910944 | Medifil | Biocore | 1991 | — |
| −6 | K030921 | Collagen Topical Wound Dressing | Collagen Matrix, Inc. | 2003 | — |
| −5 | K040211 | Modification to: Collagen Topical Wound Dressing | Collagen Matrix, Inc. | 2004 | — |
| −4 | K040558 | Modification to: Collagen Topical Wound Dressing | Collagen Matrix, Inc. | 2004 | — |
| −3 | K061746 | Collaguard, Model Fcia,Fcib,Fcic,and Fcid | Innocoll Pharmaceuticals | 2006 | — |
| −2 | K081782 | Collieva | Innocoll Pharmaceuticals | 2008 | — |
| −1 | K092805 | Collagen Sponge | Innocoll Pharmaceuticals | 2010 | — |
| 0 (this device) | K110388 | Collacare Dental | Innocoll Pharmaceuticals, Ltd. | 2011 | — |
| +1 | K122115 | Collagen Dental Wound Dressings | Collagen Matrix, Inc. | 2012 | — |
| +2 | K152600 | Collagen Dental Wound Dressings | Collagen Matrix, Inc. | 2016 | 1 |
| +1 | K133290 | Collacare Dental | Innocoll Pharmaceuticals | 2014 | — |
| +2 | K253758 | Dental Cone; Dental Sponge | Medizin Produkte Neustadt GmbH (Mpn) | 2025 | — |
| +3 | K243071 | Bovine Dermis Collagen Dermal Matrix | Collagen Matrix, Inc. | 2024 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 KGN? 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 KGN device
- #1 K231325 Corplex P / Theracor P / Allacor Pscore 17.9 · 8 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 |
|---|---|---|---|
| * | K092805 | Collagen SpongeSummary page 1…s: Unclassified Statement of Substantial Equivalence: Collacare Dental is substantially equivalent in materials of construction to Collagen Sponge (K092805), Collagen Wound dressing - Oral (K040403). Salicept Oral Patch (K01 21 26) is a hydrogel containing non-collagen materials.… | 2010 |
| * | K040403 | Collagen Wound Dressing - OralSummary page 1…ement of Substantial Equivalence: Collacare Dental is substantially equivalent in materials of construction to Collagen Sponge (K092805), Collagen Wound dressing - Oral (K040403). Salicept Oral Patch (K01 21 26) is a hydrogel containing non-collagen materials. Collacare Dental 510(k) 510(k) Summary… | 2004 |
| † | K012126 | The Salicept Oral Patch | 2001 |
What descends from it? (6)
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 20 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K122115 (Collagen Matrix, Inc., 2012) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K092805.
How does its category compare?
All KGN devicesKGN Wound Dressing With Animal-Derived Material (S): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · KGN
15so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · KGN
162in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGN
3in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGN
15in 2025
MAUDE reports naming product code KGN, 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 | 32 | 0 | 0 |
| 2008 | 6 | 87 | 0 | 1 |
| 2009 | 8 | 121 | 0 | 2 |
| 2010 | 4 | 175 | 0 | 3 |
| 2011 | 7 | 228 | 0 | 6 |
| 2012 | 8 | 123 | 0 | 4 |
| 2013 | 6 | 147 | 0 | 6 |
| 2014 | 5 | 188 | 0 | 12 |
| 2015 | 7 | 87 | 0 | 9 |
| 2016 | 4 | 164 | 0 | 6 |
| 2017 | 7 | 136 | 1 | 8 |
| 2018 | 6 | 148 | 3 | 15 |
| 2019 | 3 | 128 | 0 | 11 |
| 2020 | 5 | 279 | 0 | 17 |
| 2021 | 6 | 236 | 0 | 14 |
| 2022 | 12 | 246 | 0 | 13 |
| 2023 | 9 | 194 | 0 | 21 |
| 2024 | 13 | 83 | 0 | 15 |
| 2025 | 10 | 162 | 0 | 15 |
| 2026 | 15 | 174 | 0 | — |
What is it indicated for?
Collacare Dental is indicated for the management of oral wounds and sores, including:
*denture sores
*oral ulcers (non-infected or viral)
*periodontal surgical wounds
*suture sites
*burns
*surgical wounds and traumatic wounds
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110388: Collacare Dental.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110388
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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