510(k) · Cleared
ClearedTutodent Dental Membrane
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tutogen Medical U.S., Inc. · NPL Barrier, Animal Source, Intraoral
Cleared on May 12, 2008 after a 193-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- May 12, 2008
- Review
- 193 days
- Class
- Class II
- Product code
- NPL
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 4 citing it directly.
- This deviceK073097 Tutodent Dental MembraneTutogen Medical U.S., Inc. · 2008
- Descendant · cites it directly · 4 of its ownK101453 Vitala Natural Resorbable Collagen MembraneObi Biologics, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK141177 Vitala Porcine Derived Collagen MembraneOsteogenics Biomedical, Inc. (Formerly Obi Biologi · 2015
- Descendant · cites it directly · 3 of its ownK090216 Collagen Dental Membrane IVCollagen Matrix, Inc. · 2009
- Descendant · 3 generations on · 2 of its ownK173562 Straumann Jason MembraneInstitut Straumann AG · 2018
- Descendant · 2 generations on · 1 of its ownK100156 Collagen Dental Membrane VCollagen Matrix, Inc. · 2010 · Recalled
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K101453Vitala Natural Resorbable Collagen MembraneObi Biologics, Inc. · 2011 · cites it directly4descendants
- K141177Vitala Porcine Derived Collagen MembraneOsteogenics Biomedical, Inc. (Formerly Obi Biologi · 2015 · 2 generations on3descendants
- K090216Collagen Dental Membrane IVCollagen Matrix, Inc. · 2009 · cites it directly3descendants
- K173562Straumann Jason MembraneInstitut Straumann AG · 2018 · 3 generations on2descendants
- K100156Collagen Dental Membrane VCollagen Matrix, Inc. · 2010 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K073097 | Tutodent Dental Membrane | Tutogen Medical U.S., Inc. | 2008 | — |
| +1 | K101453 | Vitala Natural Resorbable Collagen Membrane | Obi Biologics, Inc. | 2011 | — |
| +2 | K141177 | Vitala Porcine Derived Collagen Membrane | Osteogenics Biomedical, Inc. (Formerly Obi Biologi | 2015 | — |
| +1 | K090216 | Collagen Dental Membrane IV | Collagen Matrix, Inc. | 2009 | — |
| +3 | K173562 | Straumann Jason Membrane | Institut Straumann AG | 2018 | — |
| +2 | K100156 | Collagen Dental Membrane V | Collagen Matrix, Inc. | 2010 | 6 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 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 NPL? 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 NPL device
- #1 K212463 Geistlich Bio-Gide, Geistlich Bio-Gide Shape…score 14.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | — | TutoPatch membrane Named without a submission number | |
| * | — | Collagen Dental Membrane Named without a submission number | |
| * | — | Bio-Gide Resorbable Membrane Named without a submission number | |
| * | — | BioMend Extend Named without a submission number |
What descends from it? (10)
4 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?
- Of its descendants, K101453 (Obi Biologics, Inc., 2011) has gone furthest, with 4 descendants of its own.
How does its category compare?
All NPL devicesNPL Barrier, Animal Source, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NPL
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NPL
132in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NPL
6in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NPL
39in 2025
MAUDE reports naming product code NPL, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 172 | 0 | 0 |
| 2009 | 3 | 193 | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 4 | 286 | 0 | 0 |
| 2012 | 0 | — | 3 | 3 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 5 | 140 | 0 | 3 |
| 2015 | 1 | — | 0 | 5 |
| 2016 | 3 | 184 | 0 | 9 |
| 2017 | 3 | 200 | 0 | 18 |
| 2018 | 1 | — | 0 | 14 |
| 2019 | 1 | — | 6 | 22 |
| 2020 | 2 | — | 0 | 8 |
| 2021 | 2 | — | 0 | 11 |
| 2022 | 3 | 290 | 0 | 19 |
| 2023 | 2 | — | 0 | 5 |
| 2024 | 3 | 263 | 0 | 20 |
| 2025 | 5 | 132 | 0 | 39 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This membrane is intended for use in oral surgical procedures as a resorbable material for augmentation around implants placed in immediate extraction sockets, augmentation around implants placed in delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects after root resection, cystectomy, removal of retained teeth; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073097 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073097: Tutodent Dental Membrane.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073097
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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