augmentation around implants placed in immediate extraction sockets;
augmentation around implants placed in delayed extraction sockets;
localized ridge augmentation for later implantation;
alveolar ridge reconstruction for prosthetic treatment;
filling of bone defects after root resection, cystectomy, removal of retained teeth;
guided bone regeneration in dehiscence defects; and
guided tissue regeneration procedures in periodontal defects.

Geistlich Bio-Gide® Shape is indicated for:

augmentation around implants placed in immediate extraction sockets;
augmentation around implants placed in delayed extraction sockets;
localized ridge augmentation for later implantation;
alveolar ridge reconstruction for prosthetic treatment;
filling of bone defects after root resection, cystectomy, removal of retained teeth; and
guided bone regeneration in dehiscence defects.

Geistlich Bio-Gide® Compressed is indicated for:

augmentation around implants placed in immediate extraction sockets;
augmentation around implants placed in delayed extraction sockets;
localized ridge augmentation for later implantation;
alveolar ridge reconstruction for prosthetic treatment;
filling of bone defects after root resection, cystectomy, removal of retained teeth;
guided bone regeneration in dehiscence defects, and
guided tissue regeneration procedures in periodontal defects.

Geistlich Bio-Gide® Forte is indicated for:

augmentation around implants placed in immediate extraction sockets;
augmentation around implants placed in delayed extraction sockets;
localized ridge augmentation for later implantation;
alveolar ridge reconstruction for prosthetic treatment;
filling of bone defects after root resection, cystectomy, removal of retained teeth;
guided bone regeneration in dehiscence defects, and
guided tissue regeneration procedures in periodontal defects.

Geistlich Bio-Gide® Perio is intended for the following uses:

augmentation around implants placed in immediate extraction sockets;
augmentation around implants placed in delayed extraction sockets;
localized ridge augmentation for later implantation;
alveolar ridge reconstruction for prosthetic treatment;
filling of bone defects after root resection, cystectomy, removal of retained teeth;
guided bone regeneration in dehiscence defects, and
guided tissue regeneration procedures in periodontal defects.

Geistlich Bio-Oss Collagen® is intended for the following uses:

augmentation or reconstructive treatment of the alveolar ridge;
filling of 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-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation.
Geistlich Bio-Gide® is provided in the following sizes: 13 x 25 mm, 25 x 25 mm, 30 x 40 mm, 40 x 50 mm.

Geistlich Bio-Gide® Shape is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Shape membrane has a pre-shaped form with a maximum width and height of 14 mm x 24 mm, respectively.

Geistlich Bio-Gide® Compressed is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Compressed membrane is available in two different sizes, 13 x 25 mm and 20 x 30 mm.

Geistlich Bio-Gide® Forte is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Forte membrane is available in five different sizes, 13 x 25 mm, 25 x 25 mm, 20 x 30 mm, 30 x 40 mm, and 40 x 50 mm.

Geistlich Bio-Gide® Perio is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. Pre-formed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.

Geistlich Combi-Kit Collagen is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide®. The two devices are packaged in double blisters in one package and then sterilized by gamma irradiation. Geistlich Bio-Oss Collagen® is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation. Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® bilayer membrane to be provided in the Geistlich Combi-Kit Collagen convenience kit is 16 mm x 22 mm.

Geistlich Perio-System Combi-Pack is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide® Perio. Geistlich Bio-Oss Collagen® (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation. Geistlich Bio-Gide® Perio (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® Perio bilayer membrane to be provided in the Geistlich Perio-System Combi-Pack convenience kit and as individual units is 16 mm x 22 mm. Preformed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect, and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.

AI/ML Overview

The provided FDA 510(k) clearance letter and associated S510(k) summary documents describe a class II medical device, Geistlich Bio-Gide and its variants, which are resorbable bilayer membranes and bone grafting materials. This submission is for a determination of substantially equivalent to a predicate device.

Crucially, this document is focused on demonstrating substantial equivalence based on material characteristics, manufacturing processes, and performance data for the device itself (a physical membrane and bone grafting material), not on the performance of an AI/ML powered device.

Therefore, most of the requested information regarding acceptance criteria, training/test sets, expert adjudication, MRMC studies, standalone performance, and effect sizes for AI assistance are not applicable to this type of medical device submission. The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical performance testing conducted to confirm the physical and biochemical properties of the new device are equivalent to the predicate device, especially after changes to supplier and manufacturing processes.

Here's an attempt to extract relevant information and note the inapplicable sections based on your request:

Acceptance Criteria and Device Performance (for a physical medical device)

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

Since this is not an AI/ML device, the acceptance criteria are not typically expressed in terms of accuracy, sensitivity, or specificity. Instead, they are based on physical, chemical, and biological properties demonstrating equivalence to a predicate device. The performance data provided is primarily comparative to the predicate.

Acceptance Criterion (Implied)	Reported Device Performance (Summary from Document)
Material Composition (Porcine Collagen)	Identical to predicate device.
Bilayer Structure (Porous and Dense Surfaces)	Identical to predicate device.
Sterilization Method (Gamma Irradiation)	Identical to predicate device.
Sizes Offered	Identical or similar to predicate device (differences justified as non-significant, e.g., Bio-Gide Forte).
Single-Use Status	Identical to predicate device.
Surface Morphology (SEM)	Evaluations performed; results used to support substantial equivalence.
Pore Characteristics (Porosity testing per ASTM F2450-18)	Evaluations performed; results used to support substantial equivalence.
Tensile Strength (Elongation measurements per ASTM F2150-19)	Evaluations performed; results used to support substantial equivalence.
Onset Temperature (DSC per ASTM F2212-20)	Evaluations performed; results used to support substantial equivalence.
Suture Pull-Out Force	Evaluations performed; results used to support substantial equivalence.
Device Solubility (Quantification of extractable proportion)	Evaluations performed; results used to support substantial equivalence.
Collagen Degradation (Enzymatic degradation per ASTM F2212-20)	Evaluations performed; results used to support substantial equivalence.
Molecular Weight Distribution of Proteins (SDS-PAGE per ASTM F2212-20)	Evaluations performed; results used to support substantial equivalence.
Hydration Capacity (Quantification of swelling factor)	Evaluations performed; results used to support substantial equivalence.
Biocompatibility (In vitro and in vivo per ISO 10993-1:2018)	Leveraged from predicate device (K212463).
Sterilization Validation (Per ISO 11137-1,-2,-3)	Leveraged from predicate device (K212463 / K171643).
Shelf-Life	Leveraged from predicate device (K171643).
Bench Performance	Leveraged from predicate device (K171643).
Clinical Performance	Leveraged from predicate device (K212463).
Viral Safety (Per ISO 22442-3:2007)	Evaluations performed; results used to support substantial equivalence.
Handling Properties (Only mentioned for Bio-Gide Forte & Bio-Gide Compressed)	Slight modifications for Bio-Gide Compressed to improve handling, but final product specifications are equivalent. Evaluations performed for Bio-Gide Forte.

The "analysis" column in the provided tables consistently states "The material of construction is identical," "The sizes offered are identical/similar," etc., implying the acceptance criterion is indeed identity or substantial similarity to the predicate.

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

Sample Size for Test Set: Not explicitly stated as a single "test set" in the context of an AI/ML model. The performance data consists of various physical, biochemical, and experimental tests. The number of samples for each specific test (e.g., number of membranes for tensile strength testing) is not provided.
Data Provenance: Not specified regarding country of origin. The studies are described as "in vitro and in vivo biocompatibility," "sterilization," "shelf-life," "bench," and "clinical performance studies" leveraged from previous predicate device submissions (e.g., K212463, K171643). These are likely a mix of lab-based and potentially historical clinical data. It is not specified if these are prospective or retrospective studies; however, given they are leveraged from previous clearances, they would be historical for this specific submission.

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 is not an AI/ML diagnostic device requiring expert interpretation or ground truth establishment in that manner. The "ground truth" for a resorbable membrane involves objective physical, chemical, and biological measurements, and comparison to established standards and predicate device characteristics, not expert consensus on image interpretation.

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

Not Applicable. No human adjudication method is described or relevant for the physical and chemical performance tests conducted on this medical device.

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 not an AI-assisted 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. This is not an AI algorithm. Its "standalone" performance refers to its intrinsic physical and chemical properties.

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

Not Applicable / Different Context. The "ground truth" for this device's performance is established by:
- Objective Measurements: Results of standardized physical and biochemical tests (e.g., SEM, porosity, tensile strength, DSC, solubility, degradation, molecular weight, hydration capacity, suture pull-out force).
- Regulatory Standards: Compliance with ISO and ASTM standards (e.g., ISO 10993-1, ISO 11137 series, ISO 22442-3, ASTM F2450-18, ASTM F2150-19, ASTM F2212-20).
- Predicate Device Data: Comparison and leveraging of performance data (biocompatibility, sterilization, shelf-life, bench, clinical) from previously cleared predicate devices. The claim is substantial equivalence, meaning it performs as safely and effectively as the legally marketed predicate.

8. The sample size for the training set

Not Applicable. This is a physical medical device, not an AI/ML model, so there is no "training set."

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

Not Applicable. As there is no training set for an AI/ML model, this question does not apply.

Summary of the Study Proving Device Meets Acceptance Criteria (in this context):

The "study" conducted for the Geistlich Bio-Gide product family in this 510(k) submission primarily consists of a comprehensive battery of non-clinical performance tests combined with the leveraging of existing performance data from previously cleared predicate devices. The purpose of these tests was to demonstrate that modifications (e.g., new slaughterhouse, non-significant manufacturing changes) did not alter the fundamental safety and effectiveness of the device, making it substantially equivalent to its predicates.

The non-clinical tests included:

Physical and Biochemical Testing: SEM (surface morphology), porosity, tensile strength, DSC (onset temperature), suture pull-out force, solubility, enzymatic degradation, SDS-PAGE (molecular weight distribution), and hydration capacity. For Geistlich Bio-Gide Forte and Compressed, handling properties were also evaluated.
Other Experimental Testing: Viral safety according to ISO 22442-3:2007.

These tests, performed on the modified devices, aimed to show that their properties were consistent with a product that would continue to perform as intended and as safely and effectively as the predicate devices. The acceptance criteria were implicitly that the new devices exhibit equivalent performance characteristics to the cleared predicate devices, as supported by these various in vitro and experimental studies and referencing past clinical data from the predicates.

Summary

FDA 510(k) Clearance Letter - Geistlich Bio-Gide Product Family

Page 1

Geistlich Pharma AG
℅ Roshana Ahmed
Sr. Regulatory Specialist
Telos Partners LLC
2458 Frontier Drive
Warsaw, Indiana 46582

Re: K251062
Trade/Device Name: 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
Regulation Number: 21 CFR 872.3930
Regulation Name: Bone Grafting Material
Regulatory Class: Class II
Product Code: NPL
Dated: July 15, 2025
Received: July 15, 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.

August 14, 2025

Page 2

Geistlich Pharma AG
℅ Roshana Ahmed
Sr. Regulatory Specialist
Telos Partners LLC
2458 Frontier Drive
Warsaw, Indiana 46582

August 14, 2025

Dear Roshana Ahmed:

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 3

2K251062 - Roshana Ahmed Page

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: 06/30/2023

Indications for Use

See PRA Statement below.

510(k) Number (if known)
K251062

Device Name
Geistlich Bio-Gide®

Indications for Use (Describe)

Geistlich Bio-Gide® is intended for the following uses:

augmentation around implants placed in immediate extraction sockets;
augmentation around implants placed in delayed extraction sockets;
localized ridge augmentation for later implantation;
alveolar ridge reconstruction for prosthetic treatment;
filling of bone defects after root resection, cystectomy, removal of retained teeth;
guided bone regeneration in dehiscence defects; and
guided tissue regeneration procedures in periodontal defects.

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 5

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023

Indications for Use

See PRA Statement below.

510(k) Number (if known)
K251062

Device Name
Geistlich Bio-Gide® Shape

Indications for Use (Describe)

Geistlich Bio-Gide® Shape is indicated for:

augmentation around implants placed in immediate extraction sockets;
augmentation around implants placed in delayed extraction sockets;
localized ridge augmentation for later implantation;
alveolar ridge reconstruction for prosthetic treatment;
filling of bone defects after root resection, cystectomy, removal of retained teeth; and
guided bone regeneration in dehiscence defects.

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.

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023

Indications for Use

See PRA Statement below.

510(k) Number (if known)
K251062

Device Name
Geistlich Bio-Gide® Compressed

Indications for Use (Describe)

Geistlich Bio-Gide® Compressed is indicated for:

augmentation around implants placed in immediate extraction sockets;
augmentation around implants placed in delayed extraction sockets;
localized ridge augmentation for later implantation;
alveolar ridge reconstruction for prosthetic treatment;
filling of bone defects after root resection, cystectomy, removal of retained teeth;
guided bone regeneration in dehiscence defects, and
guided tissue regeneration procedures in periodontal defects.

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.

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 7

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023

Indications for Use

See PRA Statement below.

510(k) Number (if known)
K251062

Device Name
Geistlich Bio-Gide® Forte

Indications for Use (Describe)

Geistlich Bio-Gide® Forte is indicated for:

augmentation around implants placed in immediate extraction sockets;
augmentation around implants placed in delayed extraction sockets;
localized ridge augmentation for later implantation;
alveolar ridge reconstruction for prosthetic treatment;
filling of bone defects after root resection, cystectomy, removal of retained teeth;
guided bone regeneration in dehiscence defects, and
guided tissue regeneration procedures in periodontal defects.

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.

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 8

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023

Indications for Use

See PRA Statement below.

510(k) Number (if known)
K251062

Device Name
Geistlich Bio-Gide® Perio

Indications for Use (Describe)

Geistlich Bio-Gide® Perio is intended for the following uses:

augmentation around implants placed in immediate extraction sockets;
augmentation around implants placed in delayed extraction sockets;
localized ridge augmentation for later implantation;
alveolar ridge reconstruction for prosthetic treatment;
filling of bone defects after root resection, cystectomy, removal of retained teeth;
guided bone regeneration in dehiscence defects, and
guided tissue regeneration procedures in periodontal defects.

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.

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 9

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023

Indications for Use

See PRA Statement below.

510(k) Number (if known)
K251062

Device Name
Geistlich Combi-Kit Collagen

Indications for Use (Describe)

Geistlich Bio-Gide® is intended for the following uses:

augmentation around implants placed in immediate extraction sockets;
augmentation around implants placed in delayed extraction sockets;
localized ridge augmentation for later implantation;
alveolar ridge reconstruction for prosthetic treatment;
filling of bone defects after root resection, cystectomy, removal of retained teeth;
guided bone regeneration in dehiscence defects; and
guided tissue regeneration procedures in periodontal defects.

Geistlich Bio-Oss Collagen® is intended for the following uses:

augmentation or reconstructive treatment of the alveolar ridge;
filling of 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.

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 10

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023

Indications for Use

See PRA Statement below.

510(k) Number (if known)
K251062

Device Name
Geistlich Perio-System Combi-Pack

Indications for Use (Describe)

Geistlich Bio-Gide® Perio is intended for the following uses:

augmentation around implants placed in immediate extraction sockets;
augmentation around implants placed in delayed extraction sockets;
localized ridge augmentation for later implantation;
alveolar ridge reconstruction for prosthetic treatment;
filling of bone defects after root resection, cystectomy, removal of retained teeth;
guided bone regeneration in dehiscence defects; and
guided tissue regeneration procedures in periodontal defects.

Geistlich Bio-Oss Collagen® is intended for the following uses:

augmentation or reconstructive treatment of the alveolar ridge;
filling of 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.

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 11

510(k) Summary

Geistlich Bio-Gide®

I. Submitter

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

Contact Person: Marco Steiner, Head Regulatory Affairs Management
Date Prepared: August 14, 2025

II. Device

Device Proprietary Name:	Geistlich Bio-Gide®
Common or Usual Name:	Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration
Classification Name:	Bone Grafting Material
Regulation Number:	872.3930
Product Code:	NPL
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following device:

Geistlich Bio-Gide®, K212463, Geistlich Pharma AG

The following device was referenced within the submission:

Geistlich Bio-Gide Shape, Geistlich Bio-Gide® Compressed, K171643, Geistlich Pharma AG

IV. Device Description

Page 12

Geistlich Bio-Gide® is provided in the following sizes:

13 x 25 mm
25 x 25 mm
30 x 40 mm
40 x 50 mm

V. Indications for Use

Geistlich Bio-Gide® is intended for the following uses:

augmentation around implants placed in immediate extraction sockets;
augmentation around implants placed in delayed extraction sockets;
localized ridge augmentation for later implantation;
alveolar ridge reconstruction for prosthetic treatment;
filling of bone defects after root resection, cystectomy, removal of retained teeth;
guided bone regeneration in dehiscence defects; and
guided tissue regeneration procedures in periodontal defects.

VI. Comparison of Technological Characteristics

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

The subject device is equivalent to the predicate device with respect to material characteristics, manufacturing and sterilization methods, packaging, and size. Both the subject device and predicate device have equivalent final product specifications. A comparison of the devices is provided in the table below.

Technological comparison

	Subject Device	Geistlich Bio-Gide® (K212463)	Analysis
Material	Porcine collagen	Porcine collagen	The material of construction is identical.
Sizes	13 x 25 mm25 x 25 mm30 x 40 mm40 x 50 mm	13 x 25 mm25 x 25 mm30 x 40 mm40 x 50 mm	The sizes offered are identical.
Single-Use	Yes	Yes	Both products are single use only.
Sterilization	Gamma	Gamma	Both products use gamma irradiation.

Page 13

The purpose of this submission is to notify the Agency of a new slaughterhouse for an existing supplier of animal sourced materials (K960724, K042197, K050446, K112572) as well as several non-significant changes to manufacturing facilities and equipment, as well as release testing methods.

The differences between the subject and predicate device are addressed by the information provided within this submission.

VII. Performance Data

The following data were provided in support of the substantial equivalence determination:

Physical and Biochemical Testing

Evaluation of surface morphology via Scanning Electron Microscopy (SEM)
Evaluation of pore characteristics via porosity testing based on ASTM F2450-18
Evaluation of tensile strength by elongation measurements based on ASTM F2150-19
Evaluation of onset temperature via Differential Scanning Calorimetry (DSC) based on ASTM F2212-20
Evaluation of suture pull-out force by suture pull-out testing
Evaluation of device solubility by quantification of the extractable proportion
Evaluation of collagen degradation by enzymatic degradation based on ASTM F2212-20
Evaluation of molecular weight distribution of proteins via SDS-PAGE based on ASTM F2212-20
Evaluation of the hydration capacity by quantification of the swelling factor

Other Experimental Testing

Viral safety per ISO 22442-3:2007

Results from in vitro and in vivo biocompatibility (K212463), sterilization (K212463 / K171643), shelf-life, (K171643) and bench (K171643) and clinical performance studies (K212463) from the applicant's own predicate devices were leveraged in support of substantial equivalence. The following standards were utilized: ISO 10993-1:2018, ISO 11137-1:2006, ISO 11137-2:2013, ISO 11137-3:2017, and ISO 11607-1/-2.

VIII. Conclusion

The subject device is equivalent to the predicate device with respect to intended use and technological characteristics. In addition, the results of non-clinical testing demonstrate that the subject and predicate devices have equivalent performance. Therefore, it is concluded that Geistlich Bio-Gide® is substantially equivalent to the identified predicate device.

Page 14

Geistlich Bio-Gide® Shape

I. Submitter

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

Contact Person: Marco Steiner, Head Regulatory Affairs Management
Date Prepared: August 14, 2025

II. Device

Device Proprietary Name:	Geistlich Bio-Gide® Shape
Common or Usual Name:	Collagen Resorbable Bilayer MembraneCollagen Matrix
Classification Name:	Bone Grafting Material
Regulation Number:	872.3930
Product Code:	NPL
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following device:

Geistlich Bio-Gide® Shape, K212463, Geistlich Pharma AG

The following device was referenced within the submission:

Geistlich Bio-Gide Shape, Geistlich Bio-Gide® Compressed, K171643, Geistlich Pharma AG

IV. Device Description

Page 15

The Geistlich Bio-Gide® Shape membrane has a pre-shaped form with a maximum width and height of 14 mm x 24 mm, respectively.

V. Indications for Use

Geistlich Bio-Gide® Shape is indicated for:

augmentation around implants placed in immediate extraction sockets;
augmentation around implants placed in delayed extraction sockets;
localized ridge augmentation for later implantation;
alveolar ridge reconstruction for prosthetic treatment;
filling of bone defects after root resection, cystectomy, removal of retained teeth; and
guided bone regeneration in dehiscence defects.

VI. Comparison of Technological Characteristics

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

The subject device is equivalent to the predicate device with respect to material characteristics, manufacturing and sterilization methods, packaging, and size. Both the subject and predicate device have equivalent final product specifications. A comparison of the devices is provided in the table below.

Technological comparison

	Subject Device	Geistlich Bio-Gide® Shape (K212463)	Analysis
Material	Porcine collagen	Porcine collagen	The material of construction is identical.
Sizes	14 x 24 mm (pre-shaped)	14 x 24 mm (pre-shaped)	The sizes offered are identical.
Single-Use	Yes	Yes	Both products are single-use only.
Sterilization	Gamma	Gamma	Both products use gamma irradiation.

Page 16

VII. Performance Data

The following data were provided in support of the substantial equivalence determination:

Physical and Biochemical Testing

Evaluation of surface morphology via Scanning Electron Microscopy (SEM)
Evaluation of pore characteristics via porosity testing based on ASTM F2450-18
Evaluation of tensile strength by elongation measurements based on ASTM F2150-19
Evaluation of onset temperature via Differential Scanning Calorimetry (DSC) based on ASTM F2212-20
Evaluation of suture pull-out force by suture pull-out testing
Evaluation of device solubility by quantification of the extractable proportion
Evaluation of collagen degradation by enzymatic degradation based on ASTM F2212-20
Evaluation of molecular weight distribution of proteins via SDS-PAGE based on ASTM F2212-20
Evaluation of the hydration capacity by quantification of the swelling factor

Other Experimental Testing

Viral safety per ISO 22442-3:2007

VIII. Conclusion

The subject device is equivalent to the predicate device with respect to intended use and technological characteristics. In addition, the results of non-clinical testing demonstrate that the subject and predicate devices have equivalent performance. Therefore, it is concluded that Geistlich Bio-Gide® Shape is substantially equivalent to the identified predicate device.

Page 17

Geistlich Bio-Gide® Compressed

I. Submitter

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

Contact Person: Head Regulatory Affairs Management
Date Prepared: August 14, 2025

II. Device

Device Proprietary Name:	Geistlich Bio-Gide® Compressed
Common or Usual Name:	Collagen Resorbable Bilayer MembraneCollagen Matrix
Classification Name:	Bone Grafting Material
Regulation Number:	872.3930
Product Code:	NPL
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following device:

Geistlich Bio-Gide® Compressed, K212463, Geistlich Pharma AG

The following devices were referenced within the submission:

Geistlich Bio-Gide Shape, Geistlich Bio-Gide® Compressed, K171643, Geistlich Pharma AG

IV. Device Description

Page 18

The Geistlich Bio-Gide® Compressed membrane is available in two different sizes, 13 x 25 mm and 20 x 30 mm.

V. Indications for Use

Geistlich Bio-Gide® Compressed is indicated for:

augmentation around implants placed in immediate extraction sockets;
augmentation around implants placed in delayed extraction sockets;
localized ridge augmentation for later implantation;
alveolar ridge reconstruction for prosthetic treatment;
filling of bone defects after root resection, cystectomy, removal of retained teeth;
guided bone regeneration in dehiscence defects, and
guided tissue regeneration procedures in periodontal defects.

VI. Comparison of Technological Characteristics

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

The subject device is equivalent to the predicate device with respect to material characteristics and sterilization methods, packaging, and size. Slight modifications to the manufacturing process of the predicate device were implemented to improve the handling properties of the subject device to facilitate use. No new manufacturing processes were introduced or removed when compared to the predicate device. Both the subject and predicate device have equivalent final product specifications. A comparison of the devices is provided in the table below.

Technological comparison

	Subject Device	Geistlich Bio-Gide® Compressed (K212463)	Analysis
Material	Porcine collagen	Porcine collagen	The material of construction is identical.
Sizes	13 x 25 mm20 x 30 mm	13 x 25 mm20 x 30 mm	The sizes offered are identical.
Single-Use	Yes	Yes	Both products are single-use only.
Sterilization	Gamma	Gamma	Both products use gamma irradiation.

Page 19

testing methods. The differences between the subject and predicate device are addressed by the information provided within this submission.

VII. Performance Data

The following data were provided in support of the substantial equivalence determination:

Physical and Biochemical Testing

Evaluation of surface morphology via Scanning Electron Microscopy (SEM)
Evaluation of pore characteristics via porosity testing based on ASTM F2450-18
Evaluation of tensile strength by elongation measurements based on ASTM F2150-19
Evaluation of onset temperature via Differential Scanning Calorimetry (DSC) based on ASTM F2212-20
Evaluation of suture pull-out force by suture pull-out testing
Evaluation of device solubility by quantification of the extractable proportion
Evaluation of collagen degradation by enzymatic degradation based on ASTM F2212-20
Evaluation of molecular weight distribution of proteins via SDS-PAGE based on ASTM F2212-20
Evaluation of the hydration capacity by quantification of the swelling factor

Other Experimental Testing

Viral safety per ISO 22442-3:2007

VIII. Conclusion

The subject device is equivalent to the predicate device with respect to intended use and technological characteristics. In addition, the results of non-clinical testing demonstrate that the subject and predicate devices have equivalent performance. Therefore, it is concluded that Geistlich Bio-Gide® Compressed is substantially equivalent to the identified predicate device.

Page 20

Geistlich Bio-Gide® Forte

I. Submitter

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

Contact Person: Head Regulatory Affairs Management
Date Prepared: August 14, 2025

II. Device

Device Proprietary Name:	Geistlich Bio-Gide® Forte
Common or Usual Name:	Collagen Resorbable Bilayer MembraneCollagen Matrix
Classification Name:	Bone Grafting Material
Regulation Number:	872.3930
Product Code:	NPL
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following device:

Geistlich Bio-Gide® Compressed, K212463, Geistlich Pharma AG

The following device was referenced within the submission:

Geistlich Bio-Gide Shape, Geistlich Bio-Gide® Compressed, K171643, Geistlich Pharma AG

IV. Device Description

Page 21

The Geistlich Bio-Gide® Forte membrane is available in five different sizes, 13 x 25 mm, 25 x 25 mm, 20 x 30 mm, 30 x 40 mm, and 40 x 50 mm.

V. Indications for Use

Geistlich Bio-Gide® Forte is indicated for:

augmentation around implants placed in immediate extraction sockets;
augmentation around implants placed in delayed extraction sockets;
localized ridge augmentation for later implantation;
alveolar ridge reconstruction for prosthetic treatment;
filling of bone defects after root resection, cystectomy, removal of retained teeth;
guided bone regeneration in dehiscence defects, and
guided tissue regeneration procedures in periodontal defects.

VI. Comparison of Technological Characteristics

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

The subject device is equivalent to the predicate device with respect to material characteristics, manufacturing and sterilization methods, packaging, and size. Both the subject and predicate device have equivalent final product specifications. A comparison of the devices is provided in the table below.

Technological comparison

	Subject Device	Geistlich Bio-Gide® Compressed (K212463)	Analysis
Material	Porcine collagen	Porcine collagen	The material of construction is identical.
Sizes	13 x 25 mm25 x 25 mm20 x 30 mm30 x 40 mm40 x 50 mm	13 x 25 mm20 x 30 mm	The sizes offered are similar.
Single-Use	Yes	Yes	Both products are single-use only.
Sterilization	Gamma	Gamma	Both products use gamma irradiation.

The purpose of this submission is to notify the Agency of an extension to the Geistlich Bio-Gide® product family to include Geistlich Bio-Gide® Forte as well as a new slaughterhouse for an existing supplier of animal sourced materials (K960724, K042197, K050446, K112572). The

Page 22

differences between the subject and predicate device are addressed by the information provided within this submission.

VII. Performance Data

The following data were provided in support of the substantial equivalence determination:

Physical and Biochemical Testing including comparative testing against the predicate device

Evaluation of surface morphology via Scanning Electron Microscopy (SEM)
Evaluation of pore characteristics via porosity testing based on ASTM F2450-18
Evaluation of tensile strength by elongation measurements based on ASTM F2150-19
Evaluation of onset temperature via Differential Scanning Calorimetry (DSC) based on ASTM F2212-20
Evaluation of suture pull-out force by suture pull-out testing
Evaluation of device solubility by quantification of the extractable proportion
Evaluation of collagen degradation by enzymatic degradation based on ASTM F2212-20
Evaluation of molecular weight distribution of proteins via SDS-PAGE based on ASTM F2212-20
Evaluation of the hydration capacity by quantification of the swelling factor
Evaluation of device handling properties

Other Experimental Testing

Viral safety per ISO 22442-3:2007

VIII. Conclusion

The subject device is equivalent to the predicate device with respect to intended use and technological characteristics. In addition, the results of non-clinical testing demonstrate that the subject and predicate devices have equivalent performance. Therefore, it is concluded that Geistlich Bio-Gide® Forte is substantially equivalent to the identified predicate device.

Page 23

Geistlich Bio-Gide® Perio

I. Submitter

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

Contact Person: Marco Steiner, Head Regulatory Affairs Management
Date Prepared: August 14, 2025

II. Device

Device Proprietary Name:	Geistlich Bio-Gide® Perio
Common or Usual Name:	Collagen Resorbable Bilayer Membrane
Classification Name:	Bone Grafting Material
Regulation Number:	872.3930
Product Code:	NPL
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following device:

Geistlich Bio-Gide® Perio, K212463, Geistlich Pharma AG

The following device was referenced within the submission:

Geistlich Bio-Gide Shape, Geistlich Bio-Gide® Compressed, K171643, Geistlich Pharma AG

IV. Device Description

Page 24

Pre-formed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.

V. Indications for Use

Geistlich Bio-Gide® Perio is intended for the following uses:

augmentation around implants placed in immediate extraction sockets;
augmentation around implants placed in delayed extraction sockets;
localized ridge augmentation for later implantation;
alveolar ridge reconstruction for prosthetic treatment;
filling of bone defects after root resection, cystectomy, removal of retained teeth;
guided bone regeneration in dehiscence defects, and
guided tissue regeneration procedures in periodontal defects.

VI. Comparison of Technological Characteristics

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

The subject device is equivalent to the predicate device with respect to material characteristics, manufacturing and sterilization methods, packaging, and size. Both the subject and predicate device have equivalent final product specifications. A comparison of the devices is provided in the table below.

Technological comparison

	Subject Device	Geistlich Bio-Gide® Perio (K212463)	Analysis
Material	Porcine collagen	Porcine collagen	The material of construction is identical.
Sizes	16 x 22 mm	16 x 22 mm	The sizes offered are identical.
Single-Use	Yes	Yes	Both products are single-use only.
Sterilization	Gamma	Gamma	Both products use gamma irradiation.

The purpose of this submission is to notify the Agency of a new slaughterhouse for an existing supplier of animal sourced materials (K960724, K042197, K050446, K112572) as well as

Page 25

several non-significant changes to manufacturing facilities and equipment, as well as release testing methods. The differences between the subject and predicate device are addressed by the information provided within this submission.

VII. Performance Data

The following data were provided in support of the substantial equivalence determination:

Physical and Biochemical Testing

Evaluation of surface morphology via Scanning Electron Microscopy (SEM)
Evaluation of pore characteristics via porosity testing based on ASTM F2450-18
Evaluation of tensile strength by elongation measurements based on ASTM F2150-19
Evaluation of onset temperature via Differential Scanning Calorimetry (DSC) based on ASTM F2212-20
Evaluation of suture pull-out force by suture pull-out testing
Evaluation of device solubility by quantification of the extractable proportion
Evaluation of collagen degradation by enzymatic degradation based on ASTM F2212-20
Evaluation of molecular weight distribution of proteins via SDS-PAGE based on ASTM F2212-20
Evaluation of the hydration capacity by quantification of the swelling factor

Other Experimental Testing

Viral safety per ISO 22442-3:2007

VIII. Conclusion

The subject device is equivalent to the predicate device with respect to intended use and technological characteristics. In addition, the results of non-clinical testing demonstrate that the subject and predicate devices have equivalent performance. Therefore, it is concluded that Geistlich Bio-Gide® Perio is substantially equivalent to the identified predicate device.

Page 26

Geistlich Combi-Kit Collagen

I. Submitter

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

Contact Person: Marco Steiner, Head Regulatory Affairs Management
Date Prepared: August 14, 2025

II. Device

Device Proprietary Name:	Geistlich Combi-Kit Collagen
Common or Usual Name:	Collagen Resorbable Bilayer MembraneCollagen Matrix
Classification Name:	Bone Grafting Material
Regulation Number:	872.3930
Product Code:	NPM/NPL
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following device:

Geistlich Combi-Kit Collagen, K212463, Geistlich Pharma AG

The following device was referenced within the submission:

Geistlich Bio-Gide Shape, Geistlich Bio-Gide® Compressed, K171643, Geistlich Pharma AG

IV. Device Description

Page 27

Geistlich Bio-Oss Collagen® is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation.

The size of the Geistlich Bio-Gide® bilayer membrane to be provided in the Geistlich Combi-Kit Collagen convenience kit is 16 mm x 22 mm.

V. Indications for Use

Geistlich Bio-Gide® is intended for the following uses:

augmentation around implants placed in immediate extraction sockets;
augmentation around implants placed in delayed extraction sockets;
localized ridge augmentation for later implantation;
alveolar ridge reconstruction for prosthetic treatment;
filling of bone defects after root resection, cystectomy, removal of retained teeth;
guided bone regeneration in dehiscence defects; and
guided tissue regeneration procedures in periodontal defects.

Geistlich Bio-Oss Collagen® is intended for the following uses:

augmentation or reconstructive treatment of the alveolar ridge;
filling of 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).

VI. Comparison of Technological Characteristics

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

The subject device is equivalent to the predicate device with respect to materials characteristics, manufacturing and sterilization methods, packaging, and size. Both the subject and predicate

Page 28

device have equivalent final product specifications. A comparison of the devices is provided in the table below.

	Subject Device	Predicate Device (K212463)	Analysis
Format	Convenience Kit	Convenience Kit	Both products are convenience kits.
Kit Contents	Geistlich Bio-Oss Collagen®Geistlich Bio-Gide®	Geistlich Bio-Oss Collagen®Geistlich Bio-Gide®	The contents of the kits are identical.
Sizes	Geistlich Bio-Gide®: 16 x 22 mm, Geistlich Bio-Oss Collagen® 100mg	Geistlich Bio-Gide®: 16 x 22 mm, Geistlich Bio-Oss Collagen® 100mg	The product sizes are identical.
Single-Use	Yes	Yes	Both products are single-use only.
Sterilization	Gamma	Gamma	Both products are gamma sterilized.

VII. Performance Data

The following data were provided in support of the substantial equivalence determination:

Physical and Biochemical Testing

Evaluation of surface morphology via Scanning Electron Microscopy (SEM)
Evaluation of pore characteristics via porosity testing based on ASTM F2450-18
Evaluation of tensile strength by elongation measurements based on ASTM F2150-19
Evaluation of onset temperature via Differential Scanning Calorimetry (DSC) based on ASTM F2212-20
Evaluation of suture pull-out force by suture pull-out testing
Evaluation of device solubility by quantification of the extractable proportion
Evaluation of collagen degradation by enzymatic degradation based on ASTM F2212-20
Evaluation of molecular weight distribution of proteins via SDS-PAGE based on ASTM F2212-20
Evaluation of the hydration capacity by quantification of the swelling factor

Page 29

Other Experimental Testing

Viral safety per ISO 22442-3:2007

VIII. Conclusion

The subject device is equivalent to the predicate device with respect to intended use and technological characteristics. In addition, the results of non-clinical testing demonstrate that the subject and predicate devices have equivalent performance. Therefore, it is concluded that Geistlich Combi-Kit Collagen is substantially equivalent to the identified predicate device.

Page 30

Geistlich Perio-System Combi-Pack

I. Submitter

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

Contact Person: Marco Steiner, Head Regulatory Affairs Management
Date Prepared: August 14, 2025

II. Device

Device Proprietary Name:	Geistlich Perio-System Combi Pack
Common or Usual Name:	Collagen Resorbable Bilayer MembraneCollagen Matrix
Classification Name:	Bone Grafting Material
Regulation Number:	872.3930
Product Code:	NPM/NPL
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following devices:

Geistlich Perio-System Combi Pack, K212463, Geistlich Pharma AG

The following device was referenced within the submission:

Geistlich Bio-Gide Shape, Geistlich Bio-Gide® Compressed, K171643, Geistlich Pharma AG

IV. Device Description

Page 31

Geistlich Bio-Gide® Perio (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® Perio bilayer membrane to be provided in the Geistlich Perio-System Combi-Pack convenience kit and as individual units is 16 mm x 22 mm.

Preformed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect, and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.

V. Indications for Use

Geistlich Bio-Gide® Perio is intended for the following uses:

augmentation around implants placed in immediate extraction sockets;
augmentation around implants placed in delayed extraction sockets;
localized ridge augmentation for later implantation;
alveolar ridge reconstruction for prosthetic treatment;
filling of bone defects after root resection, cystectomy, removal of retained teeth;
guided bone regeneration in dehiscence defects; and
guided tissue regeneration procedures in periodontal defects.

Geistlich Bio-Oss Collagen® is intended for the following uses:

augmentation or reconstructive treatment of the alveolar ridge;
filling of 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).

Page 32

VI. Comparison of Technological Characteristics

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

The subject device is equivalent to the predicate device with respect to materials characteristics, manufacturing and sterilization methods, packaging, and size. Both the subject and predicate device have equivalent final product specifications. A comparison of the subject and predicate device is provided in the table below.

	Subject Device	Predicate Device (K212463)	Analysis
Format	Convenience Kit	Convenience Kit	Both products are convenience kits.
Kit Contents	Geistlich Bio-Oss Collagen®Geistlich Bio-Gide® Perio	Geistlich Bio-Oss Collagen®Geistlich Bio-Gide® Perio	The contents of the kits are identical.
Sizes	Geistlich Bio-Gide® Perio: 16 x 22 mm, Geistlich Bio-Oss Collagen® 100mg	Geistlich Bio-Gide® Perio: 16 x 22 mm, Geistlich Bio-Oss Collagen® 100mg	The product sizes are identical.
Single-Use	Yes	Yes	Both products are single-use only.
Sterilization	Gamma	Gamma	Both products are gamma sterilized.

VII. Performance Data

The following data were provided in support of the substantial equivalence determination:

Physical and Biochemical Testing

Evaluation of surface morphology via Scanning Electron Microscopy (SEM)
Evaluation of pore characteristics via porosity testing based on ASTM F2450-18
Evaluation of tensile strength by elongation measurements based on ASTM F2150-19
Evaluation of onset temperature via Differential Scanning Calorimetry (DSC) based on ASTM F2212-20
Evaluation of suture pull-out force by suture pull-out testing
Evaluation of device solubility by quantification of the extractable proportion
Evaluation of collagen degradation by enzymatic degradation based on ASTM F2212-20

Page 33

Evaluation of molecular weight distribution of proteins via SDS-PAGE based on ASTM F2212-20
Evaluation of the hydration capacity by quantification of the swelling factor

Other Experimental Testing

Viral safety per ISO 22442-3:2007

VIII. Conclusion

The subject device is equivalent to the predicate device with respect to intended use and technological characteristics. In addition, the results of non-clinical testing demonstrate that the subject and predicate devices have equivalent performance. Therefore, it is concluded that Geistlich Perio-System Combi-Pack 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.