Atrisorb Bioabsorbable Guided Tissue Regneration(Gtr)
by Atrix Laboratories, Inc. 510(k)
Active
510(k) K955838
Overview
The Atrixorb Bioabsorbable Guided Tissue Regeneration (GTR) Barrier is a synthetic intraoral device classified as a barrier. It is designed to facilitate guided tissue regeneration by acting as a physical barrier during surgical procedures, promoting controlled healing and regeneration of periodontal tissues.
This device is supplied as a flowable polymeric formulation composed of poly(DL-lactide) dissolved in N-methyl-2-pyrrolidone, packaged in foil pouches with single-patient stainless steel syringes. It is intended for dental use and has received FDA 510K clearance under the Traditional pathway, classified as a Class II device (NPK). The barrier is bioabsorbable and intended for single-patient use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK955838 | Date21 Mar 1996 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- NPK
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3930
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from Atrix Laboratories, Inc.
Questions
What is the Atrixorb Bioabsorbable GTR Barrier used for in dental procedures?
The Atrixorb Bioabsorbable Guided Tissue Regeneration (GTR) Barrier is designed to act as a physical barrier during dental surgeries, specifically to promote controlled healing and regeneration of periodontal tissues. By preventing unwanted tissue growth (like gingival epithelium) and guiding stem cells to the root surface, it helps facilitate the regeneration of bone and connective tissue in periodontal defects.
How is the Atrixorb GTR Barrier supplied, and is it single-use?
The Atrixorb GTR Barrier is supplied as a flowable polymeric formulation in foil pouches, pre-loaded into single-patient stainless steel syringes. The manufacturer explicitly states it is intended for single-patient use only, meaning each syringe is non-sterile until prepared for use and must not be reused.
Is the Atrixorb GTR Barrier sterile when packaged, and how should it be stored?
The device is not described as sterile in its packaging—it is supplied in foil pouches with syringes, but sterility status isn’t explicitly confirmed. For optimal shelf life and integrity, it should be stored in a cool, dry place, away from direct sunlight, as with most medical-grade polymers. Always follow the manufacturer’s instructions for preparation and handling to ensure safety.
What materials is the Atrixorb GTR Barrier made from, and how does it dissolve?
The Atrixorb GTR Barrier is composed of poly(DL-lactide), a synthetic polymer dissolved in N-methyl-2-pyrrolidone (NMP). This formulation allows it to be delivered as a flowable substance, which then hardens and bioabsorbs over time as part of the healing process. The polymer is designed to degrade gradually in the body without leaving residual synthetic material.
What regulatory pathway was used for FDA clearance, and what class is this device?
The Atrixorb GTR Barrier received FDA clearance under the Traditional 510(k) pathway and is classified as a Class II device (NPK product code). This classification indicates it poses moderate risk and requires special controls to ensure safety and effectiveness, though it was determined to be substantially equivalent to a predicate device at the time of clearance.