510(k) · Cleared
ClearedDental Cone; Dental Sponge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medizin Produkte Neustadt GmbH (Mpn) · OLR Oral Wound Dressing
Cleared on Dec 18, 2025 as substantially equivalent to K133290 (Innocoll Pharmaceuticals, 2014) after a 23-day review. Its family tree reaches back 10 generations to 1991.
- Decided
- Dec 18, 2025
- Review
- 23 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 backK133290 Collacare DentalInnocoll Pharmaceuticals · 2014
- This deviceK253758 Dental Cone; Dental SpongeMedizin Produkte Neustadt GmbH (Mpn) · 2025
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 backK133290 Collacare DentalInnocoll Pharmaceuticals · 2014
- This deviceK253758 Dental Cone; Dental SpongeMedizin Produkte Neustadt GmbH (Mpn) · 2025
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 | K133290 | Collacare Dental | Innocoll Pharmaceuticals | 2014 | — |
| 0 (this device) | K253758 | Dental Cone; Dental Sponge | Medizin Produkte Neustadt GmbH (Mpn) | 2025 | — |
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 K260126 Curajel™ Oral Gelscore 12.4 · 4 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 |
|---|---|---|---|
| * | K133290 | Collacare DentalSummary page 5…tal Sponge Oral wound dressing Oral wound dressing Unclassified OLR, KGN Predicate Trade Name (Primary Predicate is listed first) 21 CFR 807.92(a)(3) Product Code K133290 Collacare Dental KGN Device Description Summary 21 CFR 807.92(a)(4) Dental Cone and Sponge are collagen matrices, conformabl… | 2014 |
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 34 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- None of the 15 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. 2025, 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?
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253758 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253758: Dental Cone; Dental Sponge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253758
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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