510(k) · Cleared
ClearedDental Collagen Wound Dressing (Nova Tape and NovaPlug)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novabone Products, LLC · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Jan 8, 2015 as substantially equivalent to K040403 (Collagen Matrix, Inc., 2004) after a 108-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Jan 8, 2015
- Review
- 108 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K910944 (1991). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK910944 MedifilBiocore · 1991
- 2 generations backK030921 Collagen Topical Wound DressingCollagen Matrix, Inc. · 2003
- 1 generation backK040403 Collagen Wound Dressing - OralCollagen Matrix, Inc. · 2004
- This deviceK142712 Dental Collagen Wound Dressing (Nova Tape and NovaPlug)Novabone Products, LLC · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K910944 | Medifil | Biocore | 1991 | — |
| −2 | K030921 | Collagen Topical Wound Dressing | Collagen Matrix, Inc. | 2003 | — |
| −1 | K040403 | Collagen Wound Dressing - Oral | Collagen Matrix, Inc. | 2004 | — |
| 0 (this device) | K142712 | Dental Collagen Wound Dressing (Nova Tape and NovaPlug) | Novabone Products, LLC | 2015 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K040403 | Collagen Wound Dressing - OralSummary page 4…mber: None Regulation Name: None Regulatory Class: Not Classified Product Code: KGN Legally Marketed Predicate Devices: K040403 Collagen Matrix Collagen Topical Wound Dressing - Oral NovaBone Products, L… | 2004 |
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 24 years and passes through 3 companies; a new generation was cleared every 10.7 years on median.
- None of the 7 ancestors has a recall.
- 3 other devices also cite its predicate K040403.
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. 2015, 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?
Dental Collagen Wound Dressings (NovaTape and NovaPlug) are intended for the management of oral wounds and sores, including:
* Denture sores
* Oral Ulcers (non-infected or viral)
* Periodontal surgical wounds
* Suture sites
* Burns
* Extraction sites
* Surgical wounds
* 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/K142712 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142712: Dental Collagen Wound Dressing (Nova Tape and NovaPlug).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142712
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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