510(k) · Cleared
Recalled · 2004Tefgen-FD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Custom Medical, Inc. · NPK Barrier, Synthetic, Intraoral
Cleared on Aug 15, 1994 after a 291-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 12 later devices descend from it. It has been recalled once.
- Decided
- Aug 15, 1994
- Review
- 291 days
- Class
- Class II
- Product code
- NPK
- Recalls
- 1
- Predicates
- 0
12 later devices descend from it, 2 citing it directly.
- This deviceK935137 Tefgen-FDAmerican Custom Medical, Inc. · 1994
- Descendant · cites it directly · 11 of its ownK964342 Cytoplast GBROsteogenics Co. · 1997
- Descendant · 2 generations on · 7 of its ownK972278 Cytoplast Regentex Titanium 250Osteogenics Co. · 1997 · Recalled
- Descendant · 3 generations on · 2 of its ownK143327 Neoss Ti Reinforced MembraneNeoss, Ltd. · 2015
- Descendant · cites it directly · 2 of its ownK012144 CytoflexUnicare Biomedical, Inc. · 2001
- Descendant · 3 generations on · 1 of its ownK201187 Cytoplast Titanium-Reinforced PTFE MembranesOsteogenics Biomedical, Inc. · 2021
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K964342Cytoplast GBROsteogenics Co. · 1997 · cites it directly11descendants
- K972278Cytoplast Regentex Titanium 250Osteogenics Co. · 1997 · 2 generations on7descendants
- K143327Neoss Ti Reinforced MembraneNeoss, Ltd. · 2015 · 3 generations on2descendants
- K012144CytoflexUnicare Biomedical, Inc. · 2001 · cites it directly2descendants
- K201187Cytoplast Titanium-Reinforced PTFE MembranesOsteogenics Biomedical, Inc. · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935137 | Tefgen-FD | American Custom Medical, Inc. | 1994 | — |
| +1 | K964342 | Cytoplast GBR | Osteogenics Co. | 1997 | — |
| +2 | K972278 | Cytoplast Regentex Titanium 250 | Osteogenics Co. | 1997 | 1 |
| +3 | K143327 | Neoss Ti Reinforced Membrane | Neoss, Ltd. | 2015 | — |
| +1 | K012144 | Cytoflex | Unicare Biomedical, Inc. | 2001 | — |
| +3 | K201187 | Cytoplast Titanium-Reinforced PTFE Membranes | Osteogenics Biomedical, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2001 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NPK? 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 NPK device
- #1 K221851 Lumina-PTFE Titaniumscore 7.4 · 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (12)
See all 122 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 3, 2004 | Not classified | Z-1073-04 | Other | Packaged product labeled catalog #TFS30, lot number 002419 actually contained catalog #TFR60, lot number 002441and vice versa. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K964342 (Osteogenics Co., 1997) has gone furthest, with 11 descendants of its own.
How does its category compare?
All NPK devicesNPK Barrier, Synthetic, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NPK
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NPK
529in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NPK
No recall names NPK since 2007.
Adverse event reports per year · NPK
3in 2022
MAUDE reports naming product code NPK, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 2 | — | 0 | 13 |
| 2011 | 1 | — | 0 | 35 |
| 2012 | 0 | — | 0 | 17 |
| 2013 | 1 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 3 | 529 | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K935137 · printed Nov 5, 2026
Cite this page
510(k) Report. “K935137: Tefgen-FD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K935137
Report an extraction error
Are you the manufacturer?
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