# K965205: Tefgen - LS

- Pathway: 510(k) (Traditional)
- Applicant: American Custom Medical, Inc.
- Decided: Apr 30, 1997 after 125 days
- Product code: NPK (Barrier, Synthetic, Intraoral)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) TefGen-FD membrane: named in the summary without a submission number
- (no number) GORE-TEX augmentation membrane: named in the summary without a submission number

## Most influential descendants
- K113049: Socket Graft (2012), 0 descendants of its own

## Indications for use
TefGen-LS is an implant material which is intended to be used as a temporary space making barrier over bone or other tissue.

Source page: https://510kreport.com/device/K965205
Methodology: https://510kreport.com/methodology