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…

Registry build 21.09.26

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.

2manufacturers in China registered for this device type
5catalogue numbers in this listing
9510(k) clearances naming this product code

Who Else Makes It

Concentrated in Beijing (1), Jiangsu (1).

Chinese manufacturers registered for FDA product code NPL
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

Regulatory record for Geistlich Bio-Gide®
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

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 numbers for Geistlich Bio-Gide®
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

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer