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); and
Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

Device Description

Geistlich Bio-Oss® is a biocompatible bone mineral matrix and is manufactured from purified spongiosa (cancellous) bovine bone mineral granules. The product is provided in granules or block form. Geistlich Bio-Oss® serves as a matrix consisting of interconnected macro- and micropores. The material is highly porous and has a large inner surface area.

Geistlich Bio-Oss® is provided sterile in the following configurations:

Geistlich Bio-Oss® spongiosa (cancellous) granules (0.125 g, particle size 0.25 – 1.0 mm)
Geistlich Bio-Oss® spongiosa (cancellous) granules (0.25 g, particle size 0.25 – 1.0 mm)
Geistlich Bio-Oss® spongiosa (cancellous) granules (0.5 g, particle size 0.25 – 1.0 mm)
Geistlich Bio-Oss® spongiosa (cancellous) granules (1.0 g, particle size 0.25 – 1.0 mm)
Geistlich Bio-Oss® spongiosa (cancellous) granules (2.0 g, particle size 0.25 – 1.0 mm)
Geistlich Bio-Oss® spongiosa (cancellous) granules (5.0 g, particle size 0.25 – 1.0 mm)
Geistlich Bio-Oss® spongiosa (cancellous) granules (0.5 g, particle size 1.0 – 2.0 mm)
Geistlich Bio-Oss® spongiosa (cancellous) granules (1.0 g, particle size 1.0 – 2.0 mm)
Geistlich Bio-Oss® spongiosa (cancellous) granules (2.0 g, particle size 1.0 – 2.0 mm)
Geistlich Bio-Oss® spongiosa (cancellous) block (approx. 1 x 1 x 2 cm)

Geistlich Bio-Oss Pen® is a pre-filled syringe-like applicator containing Geistlich Bio-Oss® granules. The pen allows for targeted delivery of Geistlich Bio-Oss® granules to the intended treatment site without the need for other sterile instruments.

Geistlich Bio-Oss Pen® is provided sterile in the following configurations:

Geistlich Bio-Oss Pen® (filled with 0.25 g, particle size 0.25 – 1.0 mm)
Geistlich Bio-Oss Pen® (filled with 0.5 g, particle size 0.25 – 1.0 mm)
Geistlich Bio-Oss Pen® (filled with 0.5 g, particle size 1.0 – 2.0 mm)

AI/ML Overview

This document is a 510(k) clearance letter for a bone grafting material, Geistlich Bio-Oss® and Geistlich Bio-Oss Pen®. The core claim of the submission (K251786) is that the new devices are "substantially equivalent" to previously cleared predicate devices.

The request asks for information typically found in an FDA submission for AI/ML-enabled devices, particularly those involving diagnostic aids. This 510(k) submission, however, is for a physical medical device (bone grafting material) and does not involve AI or algorithms for diagnostics or image analysis. Therefore, many of the requested elements are not applicable to this type of traditional medical device clearance.

Here's a breakdown of the requested information based on the provided document, highlighting what is not applicable:

Acceptance Criteria and Device Performance for Geistlich Bio-Oss® and Geistlich Bio-Oss Pen® (K251786)

It is crucial to understand that this 510(k) is for a physical bone grafting material, not an AI/ML-enabled diagnostic device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating substantial equivalence to predicate devices through material properties, manufacturing consistency, biocompatibility, sterilization, and basic handling characteristics, rather than diagnostic performance metrics (e.g., sensitivity, specificity, AUC) and reader studies typically associated with AI.

The primary "acceptance criterion" for this 510(k) is demonstrating substantial equivalence to the predicate devices, particularly concerning the addition of an alternate raw material supplier and minor manufacturing/release testing changes, without raising new questions of safety or effectiveness.

1. A table of acceptance criteria and the reported device performance

For a physical bone grafting material, the "acceptance criteria" relate to material composition, physical properties, biocompatibility, sterility, and manufacturing consistency. The provided document details the comparison of characteristics to the predicate and references studies demonstrating these aspects.

Acceptance Criteria Category (Implied by Submission)	Reported Device Performance (as described in 510(k))
Material Composition	Identical to predicate: purified spongiosa (cancellous) bovine bone mineral granules. (New: alternate raw material supplier for bovine material, deemed not to raise new safety/effectiveness questions.)
Form	Identical to predicate: Granules or block form. Geistlich Bio-Oss Pen® is granules pre-filled in a syringe-like applicator.
Particle Size	Identical to predicate: 0.25 – 1.0 mm, 1.0 – 2.0 mm.
Block Size	Identical to predicate: ~1 x 1 x 2 cm.
Single-Use	Identical to predicate: Yes.
Sterilization Method	Identical to predicate: Gamma, X-ray (Geistlich Bio-Oss® only).
Manufacturing Methods	Non-significant changes to manufacturing facilities and equipment. Deemed not to raise different questions of safety/effectiveness.
Release Testing Methods	Non-significant changes to release testing methods. Deemed not to raise different questions of safety/effectiveness.
Biocompatibility	Leverage results from predicate/reference devices (K120601, K240661). Conforms to ISO 10993-1:2018.
Sterilization & Shelf-Life	Leverage results from predicate/reference devices (K120601, K240661). Conforms to ISO 11137-1/2/3 and ISO 11607-1/2.
Viral Inactivation	Leverage results from reference devices (K242510, K240661). Conforms to ISO 22442-1/2/3.
Handling and Performance (Bio-Oss Pen)	Qualitative and quantitative handling and performance studies (and usability study) undertaken to support design modifications to the syringe. (Details are not in the provided text, but mentioned as having been done.)
Clinical Performance (General)	Leverage results from predicate/reference devices (K120601, K240661, K122894, K970321) for bench and non-clinical/clinical performance. No new clinical trials were explicitly required or presented in this summary for the "substantial equivalence" claim.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable in the typical AI/ML context. For a physical device like a bone graft, "test set" would typically refer to batches subjected to quality control, biocompatibility testing, or perhaps animal studies for efficacy. The document references leveraging prior studies for performance data.
Data Provenance: The document does not specify the country of origin for the leveraged study data or whether it was retrospective or prospective, as this level of detail is not required for a 510(k) summary focused on substantial equivalence of a material.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This pertains to establishing ground truth for diagnostic image interpretation, which is not relevant for a bone grafting material. Ground truth for a bone graft is established through material characterization, biocompatibility testing (e.g., cytotoxicity, sensitization, implantation tests analyzed by pathologists), and gross/histological evaluation in animal models. These "experts" would be materials scientists, toxicologists, and veterinary pathologists, but their number and specific qualifications are not detailed in this 510(k) summary because new studies of this nature were not performed for this submission; prior data was leveraged.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. This refers to consensus methods for establishing ground truth in diagnostic studies (e.g., by radiologists). This is irrelevant for a bone grafting material.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is specific to AI-enabled diagnostic devices assessing human reader performance. This device is a physical bone graft.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is specific to the performance of an AI algorithm in isolation. This device does not have an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this type of device, "ground truth" for performance relates to:
- Material Characterization: Physical and chemical properties confirmed through lab assays (e.g., composition, particle size, porosity).
- Biocompatibility: Established through standardized in vitro and in vivo tests (e.g., cytotoxicity, irritation, sensitization, genotoxicity, implantation tests), with histological and pathological evaluations of tissues for reaction.
- Sterility: Confirmed through microbiological testing.
- Viral Safety: Demonstrated through validated viral inactivation processes.
- Bench and Non-clinical/Clinical Performance: Based on previous studies (potentially animal models or human clinical data from the predicate) demonstrating the material's ability to integrate with bone, support bone formation, etc. The document generally mentions "bench and non-clinical/clinical performance" data leveraged from predicates.

8. The sample size for the training set

Not Applicable. This refers to AI model training data. This device does not use an AI model.

9. How the ground truth for the training set was established

Not Applicable. This refers to how data used to train an AI model was labeled or validated. This device does not use an AI model.

In summary, the provided FDA 510(k) letter is for a traditional physical medical device. The concepts of "acceptance criteria" and "study proving device meets acceptance criteria" for such devices revolve around demonstrating that the new device (or changes to an existing one) meets established safety and performance benchmarks relevant to its physical and biological function, primarily by showing substantial equivalence to existing, cleared devices. This is a fundamentally different assessment from that of an AI/ML diagnostic tool, which would necessitate the detailed information requested in the prompt.

Summary

FDA 510(k) Clearance Letter - Geistlich Bio-Oss® and Geistlich Bio-Oss Pen®

Page 1

Geistlich Pharma AG
℅ Roshana Ahmed
Sr. Regulatory Specialist
TELOS Partners LLC
2850 Frontier Drive
Warsaw, Indiana 46582

Re: K251786
Trade/Device Name: Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®
Regulation Number: 21 CFR 872.3930
Regulation Name: Bone Grafting Material
Regulatory Class: Class II
Product Code: NPM
Dated: June 11, 2025
Received: June 11, 2025

July 11, 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.

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K251786 - 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-

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K251786 - Roshana Ahmed
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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 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026

Indications for Use

See PRA Statement below.

510(k) Number (if known)
K251786

Device Name
Geistlich Bio-Oss® and Geistlich Bio-Oss Pen®

Indications for Use (Describe)

Geistlich Bio-Oss® 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); and
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
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FORM FDA 3881 (8/23)
Page 1 of 1

Page 5

510(k) Summary

Geistlich Bio-Oss® and Geistlich Bio-Oss® Pen
Geistlich Pharma AG
Traditional 510(k) K251786
Page 1 of 4

I. Submitter

Geistlich Pharma AG
Bahnhofstrasse 40
CH-6110 Wolhusen
Switzerland
Phone: +41 41 492 55 55

Contact Person: Erik Wirth, Team Lead Regulatory Services
Date Prepared: July 10, 2025

II. Device

Device Proprietary Name:	Geistlich Bio-Oss®
	Geistlich Bio-Oss Pen®
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:

Geistlich Bio-Oss®, K240661, Geistlich Pharma AG
Geistlich Bio-Oss® Pen, K120601, Geistlich Pharma AG

The following device is referenced within the submission:

Geistlich Bio-Flow®, K242510, Geistlich Pharma AG
Geistlich Bio-Oss(R), K122894, Geistlich Pharma AG
Bio-Oss Anorganic Bovine Bone, K970321, Geistlich-Pharma

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Geistlich Bio-Oss® and Geistlich Bio-Oss® Pen
Geistlich Pharma AG
Traditional 510(k) K251786
Page 2 of 4

IV. Device Description

Geistlich Bio-Oss® is provided sterile in the following configurations:

Geistlich Bio-Oss® spongiosa (cancellous) granules (0.125 g, particle size 0.25 – 1.0 mm)
Geistlich Bio-Oss® spongiosa (cancellous) granules (0.25 g, particle size 0.25 – 1.0 mm)
Geistlich Bio-Oss® spongiosa (cancellous) granules (0.5 g, particle size 0.25 – 1.0 mm)
Geistlich Bio-Oss® spongiosa (cancellous) granules (1.0 g, particle size 0.25 – 1.0 mm)
Geistlich Bio-Oss® spongiosa (cancellous) granules (2.0 g, particle size 0.25 – 1.0 mm)
Geistlich Bio-Oss® spongiosa (cancellous) granules (5.0 g, particle size 0.25 – 1.0 mm)
Geistlich Bio-Oss® spongiosa (cancellous) granules (0.5 g, particle size 1.0 – 2.0 mm)
Geistlich Bio-Oss® spongiosa (cancellous) granules (1.0 g, particle size 1.0 – 2.0 mm)
Geistlich Bio-Oss® spongiosa (cancellous) granules (2.0 g, particle size 1.0 – 2.0 mm)
Geistlich Bio-Oss® spongiosa (cancellous) block (approx. 1 x 1 x 2 cm)

Geistlich Bio-Oss Pen® is provided sterile in the following configurations:

Geistlich Bio-Oss Pen® (filled with 0.25 g, particle size 0.25 – 1.0 mm)
Geistlich Bio-Oss Pen® (filled with 0.5 g, particle size 0.25 – 1.0 mm)
Geistlich Bio-Oss Pen® (filled with 0.5 g, particle size 1.0 – 2.0 mm)

V. Indications for Use

Geistlich Bio-Oss® 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); and

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Geistlich Bio-Oss® and Geistlich Bio-Oss® Pen
Geistlich Pharma AG
Traditional 510(k) K251786
Page 3 of 4

Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

VI. Comparison of Technological Characteristics

The Indications for Use Statement is identical to the predicate device.

The subject device is identical to the predicate device with respect to materials characteristics, manufacturing and sterilization methods, packaging, and size. Both the subject and predicate devices have identical final product specifications.

Subject Devices	Geistlich Bio-Oss® (K240661) Geistlich Bio-Oss Pen® (K120601)
Material	Geistlich Bio-Oss®
Form	Block or Granules (Bio-Oss® Pen – granules prefilled in syringe like applicator)
Particle Size	0.25 – 1.0 mm, 1.0 – 2.0 mm
Block Size	1 x 1 x 2 cm
Single-Use	Yes
Sterilization	Gamma, X-ray (Geistlich Bio-Oss® only)

The purpose of this submission is to obtain clearance for use of an alternate supplier of bovine raw material and to notify the Agency of non-significant changes to manufacturing facilities and equipment, and release testing methods. These changes do not raise different questions of safety and effectiveness when compared to the predicate device and the testing to support the minor technological differences are discussed in the Performance Data section below.

VII. Performance Data

Results from viral inactivation studies (K242510 and K240661), biocompatibility (K120601 and K240661), sterilization and shelf-life (K120601 and K240661), and bench and non-clinical/clinical performance (K120601, K240661, K122894 and K970321) studies from the applicant's own predicate and reference devices were leveraged in support of substantial equivalence.

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Geistlich Bio-Oss® and Geistlich Bio-Oss® Pen
Geistlich Pharma AG
Traditional 510(k) K251786
Page 4 of 4

The following standards were utilized:

ISO 22442-1:2020
ISO 22442-2:2020
ISO 22442-3:2007
ISO 10993-1:2018
ISO 11137-1:2006
ISO 11137-2:2013
ISO 11137-3:2017
ISO 11607-1/-2

Qualitative and quantitative handling and performance studies as well as a usability study were undertaken to support design modifications to the Geistlich Bio-Oss® Pen syringe.

VIII. Conclusion

The subject devices are identical to the predicate devices. The addition of a new raw material supplier does not raise different questions of safety and effectiveness. Therefore, it is concluded that Geistlich Bio-Oss® and Geistlich Bio-Oss Pen® are substantially equivalent to the identified predicate devices.

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.