# K982865: Atrisorb Bioabsorbable Guided Tissue Regeneration (GTR) Barrier Kit

- Pathway: 510(k) (Special)
- Applicant: Atrix Laboratories, Inc.
- Decided: Sep 8, 1998 after 26 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.
6 later devices descend from it; 4 cite it directly.
0 of 7 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) GORE-TEX® Periodontal Material: named in the summary without a submission number

## Most influential descendants
- K082111: Straumann Membragel (2009), 1 descendant of its own
- K060285: Bonegen - TR (2006), 1 descendant of its own
- K131385: Easy-Graft (2013), 0 descendants of its own
- K102208: Nanogen (2011), 0 descendants of its own
- K101956: Straumann Membragel (2010), 0 descendants of its own

## Recalls of this device
- Jan 26, 2006 · Not classified · Z-0476-06: Injectable needles were included in procedure kits instead of sterile blunt cannulas.

## Indications for use
ATRISORB® GTR Barrier is indicated for the surgical treatment of periodonital defects to aid in the regeneration and integration of tissue components in guided tissue rageneration procedures. ATRISORB® GTR Barrier is not intended for use in defects outside the indications statement.

Source page: https://510kreport.com/device/K982865
Methodology: https://510kreport.com/methodology