Ossix® Breeze
OSSIX Breeze is a biodegradable collagen barrier membrane for guided bone and tissue regeneration in dental procedures. It is made from decellularized porcine pericardium, with ribose cross…
OSSIX Breeze is a biodegradable collagen barrier membrane for guided bone and tissue regeneration in dental procedures. It is made from decellularized porcine pericardium, with ribose cross linking and a porous, fibrous microstructure.
The membrane is used alone or with suitable bone augmentation materials. Indications include ridge augmentation or preservation after extraction, periodontal and intrabony defects, and use over the window during sinus elevation procedures.
Listed Item
Cross-linked pericardium membrane
Size and Clinical Use
Available sizes range from 10 by 12 mm to 30 by 40 mm. The membrane is packaged in a double blister and sterilized with ethylene oxide. It is intended for adults and for use by trained dentists or oral surgeons.
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) | K212509 |
| Record published | 2022-09-05 |
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 |
| Sizes | Width 10 to 30 mm; length 12 to 40 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 68018006 | Width 20 mm | In distribution |
| 68018005 | Width 15 mm | In distribution |
| 68018004 | Width 10 mm | In distribution |
| 68018007 | Width 30 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.