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).

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.

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for a bone grafting material called "SwissGraft X." It does not describe an AI medical device or present a study comparing the device's performance against acceptance criteria in the manner typically expected for AI/software-as-a-medical-device (SaMD) clearances.

Instead, this document describes a traditional medical device (bone grafting material) seeking clearance based on substantial equivalence to a predicate device. The performance data section refers to standard biocompatibility, sterilization, shelf-life, and packaging validation, along with characterization of structural, mechanical properties, and granule size distribution – all common for a physical medical product.

Therefore, many of the requested elements (e.g., acceptance criteria for diagnostic performance, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for training/test sets) are not applicable to the information contained in this specific FDA clearance letter for SwissGraft X.

Here's an analysis based on the available information, with notes where information is not present or not applicable to an AI device:

1. Table of Acceptance Criteria and Reported Device Performance

As "SwissGraft X" is a bone grafting material and not an AI or diagnostic device, the acceptance criteria relate to its physical and biological properties rather than diagnostic performance metrics (like sensitivity, specificity, AUC). The document refers to "testing against final product specifications" and "characterization of structural and mechanical properties" for the new product line's smaller granule sizes and different filling weights compared to the predicate device. Specific numerical acceptance criteria or performance values are not detailed in this summary, but the conclusion states that these evaluations support substantial equivalence.

Acceptance Criteria Category (Implied from Performance Data)	Reported Device Performance
Material Biocompatibility	Results from applicant's own predicate device (K240661) were leveraged. Implied to meet established standards. Specific results not provided in this summary.
Sterilization Efficacy	Results from applicant's own predicate device (K240661) were leveraged. Implied to meet established standards for X-ray sterilization. Specific results not provided in this summary.
Shelf-Life Stability	Results from applicant's own predicate device (K240661) were leveraged. Implied to demonstrate stability over its intended shelf life. Specific results not provided in this summary.
Packaging Validation	Results from applicant's own predicate device (K240661) were leveraged. Implied to ensure package integrity and sterility. Specific results not provided in this summary.
Final Product Specifications	"Testing against final product specifications" undertaken. Implied to meet all defined specifications for the device. Specific numerical specifications or results not provided in this summary.
Pore, Surface, and Internal Structure Characteristics	"Characterization of structural and mechanical properties" undertaken. Implied to be comparable to the predicate device within acceptable ranges. Specific results not provided in this summary.
Liquid Uptake	"Characterization of structural and mechanical properties" undertaken. Implied to be comparable to the predicate device within acceptable ranges. Specific results not provided in this summary.
Granule Size Distribution	"Characterization of structural and mechanical properties" undertaken (including Granule size distribution). The device has a reduced granule size range (0.25-0.6 mm) compared to the predicate (0.25-1.0 mm, 1.0-2.0 mm), but this was the specific change being evaluated and found to be sufficiently similar for substantial equivalence. Specific results not provided in this summary, but the conclusion of substantial equivalence implies acceptable performance.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the 510(k) summary as it typically would be for a clinical validation or AI performance study. The "Performance Data" section states that results from the applicant's own predicate device (K240661) were "leveraged" for biocompatibility, sterilization, shelf-life, and packaging validation. For the specific differences (granule size and filling weights), "testing against final product specifications" and "characterization of structural and mechanical properties" were undertaken. The exact sample sizes for these bench tests are not disclosed.

Data Provenance: The manufacturer is "Geistlich Pharma AG" based in Wolhusen, Switzerland. The predicate device's data was used, but details on the provenance of those original studies are not given here. The studies mentioned are primarily bench/laboratory based for material characterization, not typically clinical or retrospective/prospective data sets in the AI sense.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This concept is not applicable here. The device is a physical bone grafting material, not a diagnostic AI that requires expert-established ground truth for performance evaluation. Its performance is assessed through laboratory tests (e.g., material characterization, sterilization validation) against technical specifications, not against expert clinical diagnoses.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of expert adjudication for diagnostic accuracy.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a clearance for a bone grafting material, not an AI device, so MRMC studies are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. "SwissGraft X" is not an algorithm or software. It is a physical bone grafting material.

7. The Type of Ground Truth Used

For a physical device like SwissGraft X, "ground truth" refers to established scientific/engineering principles, material standards, and validated test methods (e.g., for biocompatibility, sterility, material properties) rather than clinical ground truth (like pathology or expert consensus). The product is evaluated against its own "final product specifications" and characterization results are compared against those of the predicate device.

8. The Sample Size for the Training Set

Not applicable. The device is a physical product, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. The device is a physical product, not an AI model that requires a ground truth for a training set.

Summary

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

Dear Roshana Ahmed:

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

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 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 mm1.0 – 2.0 mm	Similar
Configurations	0.15 g0.25 g0.3 g0.5 g0.75 g1.0 g1.5 g	0.125 g0.25 g0.5 g1.0 g2.0 g5.0 g	Similar
Single-Use	Yes	Yes	Identical
Sterilization	X-ray	X-rayGamma	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.

Regulation Number and Section

§ 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.