# K935137: Tefgen-FD

- Pathway: 510(k) (Traditional)
- Applicant: American Custom Medical, Inc.
- Decided: Aug 15, 1994 after 291 days
- Product code: NPK (Barrier, Synthetic, Intraoral)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K964342: Cytoplast GBR (1997), 11 descendants of its own
- K972278: Cytoplast Regentex Titanium 250 (1997), 7 descendants of its own
- K143327: Neoss Ti Reinforced Membrane (2015), 2 descendants of its own
- K012144: Cytoflex (2001), 2 descendants of its own
- K201187: Cytoplast Titanium-Reinforced PTFE Membranes (2021), 1 descendant of its own

## Recalls of this device
- Jun 3, 2004 · Not classified · Z-1073-04: Packaged product labeled catalog #TFS30, lot number 002419 actually contained catalog #TFR60, lot number 002441and vice versa.

Source page: https://510kreport.com/device/K935137
Methodology: https://510kreport.com/methodology