Ossix® Volumax
OSSIX VOLUMAX is a resorbable collagen membrane used by dental surgeons as a barrier during guided bone and tissue regeneration. Applications include ridge augmentation, extraction site…
OSSIX VOLUMAX is a resorbable collagen membrane used by dental surgeons as a barrier during guided bone and tissue regeneration. Applications include ridge augmentation, extraction site preservation, defects around teeth and implants, sinus elevation and localized gingival augmentation.
The porous network of collagen fibers absorbs fluid and adheres to surrounding tissue, forming the regenerative barrier. The material is purified porcine type I collagen cross-linked with ribose and is designed to biodegrade.
Use Restrictions
The membrane must not be used in patients with collagen hypersensitivity, sensitivity to porcine materials or autoimmune and connective tissue disease. Use around infected implants with vertical bone loss requires satisfactory debridement and implant surface disinfection. It is supplied ethylene oxide sterilized in double blister packaging.
Who Else Makes It
Concentrated in Beijing (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Biosis Healing Biological Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| NEO Modulus (Suzhou) Medical SCI-Tech Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Datum Dental, Ltd., Israel |
|---|---|
| FDA product code | NPL |
| Device type | Barrier, Animal Source, Intraoral |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3930 |
| 510(k) | K153549 |
| Record published | 2016-09-01 |
| Record revised | 2026-02-09 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 59 to 86 °F |
| Sizes | Width 10 to 25 mm; length 12.5 to 40 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OXV1040 | Width 10 mm | In distribution |
| OXV1525 | Width 15 mm | In distribution |
| OXV1012 | Length 12.5 mm | In distribution |
| OXV2530 | Width 25 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neocirrus | NEO Modulus (Suzhou) Medical SCI-Tech Co., Ltd. | 18 |
| Gibson Healthcare | Benco Dental Supply Co. | 18 |
| Endoform™ Dental Membrane | Aroa Biosurgery Ltd | 12 |
| Ousia bioADAPT | Ace Surgical Supply Co., Inc. | 9 |
| GuidOss | Nibec Co Ltd | 9 |
| RCM6 Resorbable Collagen Membrane | Ace Surgical Supply Co., Inc. | 9 |
| Ousia bioMAINTAIN | Ace Surgical Supply Co., Inc. | 9 |
| Genoss Collagen Membrane | Genoss Co., Ltd. | 9 |
| bioMAINTAIN | Collagen Matrix, Inc. | 9 |
| Salvin Dental Specialties | Salvin Dental Specialties, LLC | 8 |
| THE Cover | Purgo Biologics Inc. | 8 |
| PerioMatrix | Collagen Matrix, Inc. | 7 |
Showing 12 of 132. All products under Barrier, Animal Source, Intraoral
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212509 | 2022-07-18 |
| K160281 | 2016-08-04 |
| K153549 | 2016-08-04 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.