# K020396: Biocellect -Perio

- Pathway: 510(k) (Traditional)
- Applicant: Imtec Corp.
- Decided: Apr 10, 2002 after 63 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- 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
Longest line of descent: 1 generation back to K940643 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940643: Osmed Epi-Guide, Thm Biomedical, Inc. (1996) Summary page 1.

## Indications for use
BioCELLECT™-perio is a bioabsorbable implantable membrane intended for use in the surgical management and treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures. It is also used as a membrane that provides a stable barrier for the containment of bone graft material. Its composition allows a relative short term resorption.

Source page: https://510kreport.com/device/K020396
Methodology: https://510kreport.com/methodology