(30 days)
Not Found
No.
The document describes a bone mineral matrix for dental and orthopedic applications. There is no mention of any computational or intelligent capabilities, nor any reference to AI, machine learning, or deep neural networks.
Yes
SwissGraft X is used for augmentation, reconstructive treatment, and filling various defects, which are therapeutic interventions.
No
The device, SwissGraft X, is described as a bone mineral matrix intended for augmentation and reconstructive treatments, filling defects, and other regenerative procedures. Its function is to serve as a matrix for bone regeneration, not to diagnose medical conditions.
No
The device description explicitly states "SwissGraft X is a biocompatible bone mineral matrix and is manufactured from purified spongiosa (cancellous) bovine bone mineral granules." This indicates it is a physical product, not a software product. The uses are also for physical augmentation and filling within the body.
No.
The device is a bone mineral matrix used for augmentation and filling defects, not for in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
SwissGraft X is intended for the following uses:
- augmentation or reconstructive treatment of the alveolar ridge
- filling of infrabony periodontal defects
- filling of defects after root resection, apicoectomy, and cystectomy
- filling of extraction sockets to enhance preservation of the alveolar ridge
- elevation of the maxillary sinus floor
- filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
Product codes (comma separated list FDA assigned to the subject device)
NPM
Device Description
SwissGraft X is a biocompatible bone mineral matrix and is manufactured from purified spongiosa (cancellous) bovine bone mineral granules. SwissGraft X serves as a matrix consisting of interconnected macro- and micropores. The material is highly porous, hydrophilic, and has a large inner surface area. SwissGraft X is sterilized by x-ray irradiation.
SwissGraft X is provided in granule form in the following fill sizes:
- 0.15 g, particle size 0.25 – 0.6 mm
- 0.25 g, particle size 0.25 – 0.6 mm
- 0.3 g, particle size 0.25 – 0.6 mm
- 0.5 g, particle size 0.25 – 0.6 mm
- 0.75 g, particle size 0.25 – 0.6 mm
- 1.0 g, particle size 0.25 – 0.6 mm
- 1.5 g, particle size 0.25 – 0.6 mm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alveolar ridge, infrabony periodontal defects, defects after root resection, apicoectomy, and cystectomy, extraction sockets, maxillary sinus floor, periodontal defects, peri-implant defects
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Results from biocompatibility, sterilization, shelf-life, packaging validation, bench and clinical performance studies from the applicant's own predicate device (K240661) were leveraged in support of substantial equivalence.
Based on the results of assessment, the following evaluations were undertaken:
- testing against final product specifications
- characterization of structural and mechanical properties
- Pore, surface and internal structure characteristics
- Liquid Uptake
- Granule size distribution
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
FDA 510(k) Clearance Letter - SwissGraft X
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
Geistlich Pharma AG
℅ Roshana Ahmed
Sr. Regulatory Specialist
TELOS Partners LLC
2850 Frontier Drive
Warsaw, Indiana 46582
Re: K251613
Trade/Device Name: SwissGraft X
Regulation Number: 21 CFR 872.3930
Regulation Name: Bone Grafting Material
Regulatory Class: Class II
Product Code: NPM
Dated: May 27, 2025
Received: May 27, 2025
Dear Roshana Ahmed:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
June 26, 2025
Page 2
U.S. FOOD & DRUG ADMINISTRATION
Geistlich Pharma AG
℅ Roshana Ahmed
Sr. Regulatory Specialist
TELOS Partners LLC
2850 Frontier Drive
Warsaw, Indiana 46582
June 26, 2025
Re: K251613
Trade/Device Name: SwissGraft X
Regulation Number: 21 CFR 872.3930
Regulation Name: Bone Grafting Material
Regulatory Class: Class II
Product Code: NPM
Dated: May 27, 2025
Received: May 27, 2025
Dear Roshana Ahmed:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Page 3
K251613 - Roshana Ahmed Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
Page 4
K251613 - Roshana Ahmed Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sherrill Lathrop Blitzer
for Andrew Steen
Assistant Director
DHT1B: Division of Dental and ENT Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 5
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known): K251613
Device Name: SwissGraft X
Indications for Use (Describe)
SwissGraft X is intended for the following uses:
- augmentation or reconstructive treatment of the alveolar ridge
- filling of infrabony periodontal defects
- filling of defects after root resection, apicoectomy, and cystectomy
- filling of extraction sockets to enhance preservation of the alveolar ridge
- elevation of the maxillary sinus floor
- filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 6
510(k) Summary
SwissGraft X
Special 510(k): K251613
Geistlich Pharma AG
Page 1 of 3
I. Submitter
Geistlich Pharma AG
Bahnhofstrasse 40
CH-6110 Wolhusen
Switzerland
Phone: +41 41 492 53 39
Contact Person: Erik Wirth, Team Lead Regulatory Services
Date Prepared: June 26, 2025
II. Device
| Device Proprietary Name: | SwissGraft X |
| Common or Usual Name: | Bone Grafting Material |
| Classification Name: | Bone Grafting Material, animal source |
| Regulation Number: | 872.3930 |
| Product Code: | NPM |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following device:
| Product Name | 510(k) | Applicant |
|---|---|---|
| Geistlich Bio-Oss® | K240661 | Geistlich Pharma AG |
IV. Device Description
SwissGraft X is a biocompatible bone mineral matrix and is manufactured from purified spongiosa (cancellous) bovine bone mineral granules. SwissGraft X serves as a matrix consisting of interconnected macro- and micropores. The material is highly porous, hydrophilic, and has a large inner surface area. SwissGraft X is sterilized by x-ray irradiation.
SwissGraft X is provided in granule form in the following fill sizes:
- 0.15 g, particle size 0.25 – 0.6 mm
- 0.25 g, particle size 0.25 – 0.6 mm
- 0.3 g, particle size 0.25 – 0.6 mm
Page 7
SwissGraft X
Special 510(k): K251613
Geistlich Pharma AG
Page 2 of 3
- 0.5 g, particle size 0.25 – 0.6 mm
- 0.75 g, particle size 0.25 – 0.6 mm
- 1.0 g, particle size 0.25 – 0.6 mm
- 1.5 g, particle size 0.25 – 0.6 mm
V. Indications for Use
SwissGraft X is intended for the following uses:
- augmentation or reconstructive treatment of the alveolar ridge
- filling of infrabony periodontal defects
- filling of defects after root resection, apicoectomy, and cystectomy
- filling of extraction sockets to enhance preservation of the alveolar ridge
- elevation of the maxillary sinus floor
- filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
VI. Comparison of Technological Characteristics
The indications for use statements for the subject and predicate devices are identical.
The subject device is equivalent to the predicate device with respect to material characteristics, manufacturing and sterilization methods, packaging, and size. A comparison of the devices is provided in the table below.
| SwissGraft X | Geistlich Bio-Oss® (K240661) | Analysis | |
|---|---|---|---|
| Manufacturer | Geistlich Pharma AG | Geistlich Pharma AG | Identical |
| Animal Material | Mineral of bovine origin | Mineral of bovine origin | Identical |
| Shape | Granules | Granules | Identical |
| Granule Sizes | 0.25 – 0.6 mm | 0.25 – 1.0 mm | |
| 1.0 – 2.0 mm | Similar | ||
| Configurations | 0.15 g | ||
| 0.25 g | |||
| 0.3 g | |||
| 0.5 g | |||
| 0.75 g | |||
| 1.0 g | |||
| 1.5 g | 0.125 g | ||
| 0.25 g | |||
| 0.5 g | |||
| 1.0 g | |||
| 2.0 g | |||
| 5.0 g | Similar | ||
| Single-Use | Yes | Yes | Identical |
| Sterilization | X-ray | X-ray | |
| Gamma | Identical |
Page 8
SwissGraft X
Special 510(k): K251613
Geistlich Pharma AG
Page 3 of 3
The purpose of this submission is to obtain clearance for SwissGraft X which is part of a new product line to the existing legally marketed Geistlich Bio-Oss® products. This new product line includes a reduced granule size range and different filling weights, all within the size range and filling configurations cleared for the predicate device. The minor technological differences between the subject and predicate device are the granule sizes and configurations. The testing of these differences is discussed in the Performance Data section below.
VII. Performance Data
Results from biocompatibility, sterilization, shelf-life, packaging validation, bench and clinical performance studies from the applicant's own predicate device (K240661) were leveraged in support of substantial equivalence.
Based on the results of assessment, the following evaluations were undertaken:
- testing against final product specifications
- characterization of structural and mechanical properties
- Pore, surface and internal structure characteristics
- Liquid Uptake
- Granule size distribution
VIII. Conclusion
The information provided above supports that SwissGraft X has the same intended use and similar technological characteristics as the predicate device. Therefore, it is concluded that SwissGraft X is substantially equivalent to the identified predicate device.