510(k) K042197
- Device
- BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION
- Applicant
- ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE
- 510(k) number
- K042197
- Product code
- NPL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-11-15
- Date received
- 2004-08-13
- Regulation
- 872.3930
- Classification name
- Barrier, Animal Source, Intraoral
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PETER S REICHERTZ
- Address
- 1301 K St. NW Suite 600 Washington DC US 20005 20005
FDA Registration Numbers#
- 8043792
- 3009598981
- 3043657402
- 3011649314
- 3013037032
- 3014448321
- 3007113424
- 3004884150
- 2245304
- 3016823837
- 1047843
- 1650372
- 2249852
- 3009039068
- 1066741
- 2032542
- 9614442
- 3010097171
- 3002807112
- 3011824442
- 3006223010
- 3027448274
- 2028523
- 3007679154
- 3002808022
- 3019834892
- 2022435
- 3008729892
- 1000393132
- 3008910197
- 1319660
- 2530154
- 3004431266
- 2246552
- 3007321028
- 3009506228
- 1647098
- 3014015147
- 2087119
- 3011276344
- 3006017180
- 1313525
- 3002719998
- 9613348
- 3002924436
- 3014206569
- 3010155661
- 3004681519
- 3003300673
- 3013820501
- 3017399129
- 3017847628
- 3002808271
- 3016668451
- 1835959
- 3009443653
Source Documents#
Other 510(k) Records For Product Code NPL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242817 | Jason membrane | Botiss Biomaterials GmbH | 2025-12-12 |
| K250512 | Augmented Gingival Matrix | Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. | 2025-12-05 |
| K252253 | Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® | Geistlich Pharma AG | 2025-11-25 |
| K251062 | Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack | Geistlich Pharma AG | 2025-08-14 |
| K250833 | SwissMembrane X; SwissMembrane X Socket | Geistlich Pharma AG | 2025-04-15 |
| K233203 | Soft Tissue Augmentation Resorbable Matrix | Collagen Matrix, Inc. | 2024-05-01 |
| K231513 | Oral Matrix | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2024-02-16 |
| K231305 | Endoform Dental Membrane | Aroa Biosurgery , Ltd. | 2024-01-23 |
| K230091 | THE Cover | Purgo Biologics, Inc. | 2023-10-06 |
| K223912 | InterCollagen® Guide | Sigmagraft, Inc. | 2023-08-17 |
| K213904 | Kerecis Oral | Kerecis | 2022-09-30 |
| K212509 | OSSIX Breeze | Datum Dental, Ltd. | 2022-07-18 |
| K212463 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi Pack | Geistlich Pharma AG | 2022-04-05 |
| K210280 | Geistlich Mucograft®, Geistlich Mucograft® Seal | Geistlich Pharma AG | 2021-03-03 |
| K201241 | Striate+™ | Orthocell, Ltd. | 2021-01-11 |
Legacy Summary#
summary
FDA Review#
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