Geistlich Bio-Gide®
Geistlich Bio-Gide is a porcine collagen membrane with two distinct layers for oral bone and tissue regeneration. The porous side faces bone and permits bone-forming cell ingrowth. The…
Geistlich Bio-Gide is a porcine collagen membrane with two distinct layers for oral bone and tissue regeneration. The porous side faces bone and permits bone-forming cell ingrowth. The dense side faces soft tissue and limits fibrous connective tissue entering the bone defect.
The collagen is not further cross-linked. Indications include ridge augmentation or reconstruction, augmentation around implants in immediate or delayed extraction sockets, selected post-surgical bone defects, dehiscence defects and periodontal guided tissue regeneration.
Sizes and Supply
The membrane is supplied in 13 by 25, 25 by 25, 30 by 40 and 40 by 50 mm sizes. It is sterilized by gamma irradiation and intended for single use. Its barrier function separates the bone-facing and soft-tissue-facing environments during the specified regenerative procedures.
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 | Geistlich Pharma AG, Switzerland |
|---|---|
| FDA product code | NPL |
| Device type | Barrier, Animal Source, Intraoral |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3930 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K251062 |
| Record published | 2020-12-01 |
| Record revised | 2018-03-29 (version 2) |
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 13 to 40 mm; height 22 to 50 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 500710 | Width 30 mm | In distribution |
| 20153 | Width 40 mm | In distribution |
| 20151 | Height 25 mm | In distribution |
| 502113 | Width 16 mm | In distribution |
| 20152 | 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 |
|---|---|
| K252253 | 2025-11-25 |
| K251062 | 2025-08-14 |
| K250833 | 2025-04-15 |
| K212463 | 2022-04-05 |
| K210280 | 2021-03-03 |
| K192042 | 2019-08-29 |
| K171050 | 2017-11-09 |
| K171643 | 2017-10-30 |
| K140518 | 2014-07-18 |
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.