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).

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-Oss® spongiosa (cancellous) granules and Geistlich Bio-Oss® spongiosa (cancellous) Block (referred as Geistlich Bio-Oss®) are intended for filling and augmentation of bony voids and gaps in maxillofacial surgery, implantology, and periodontology according to the intended use of the product.

Geistlich Bio-Oss® is serving 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 a biocompatible bone mineral matrix and is manufactured from bovine bone in a validated multistage purification process to remove the organic components.

Due to the interconnected macro and microporous system the device is hydrophilic and easv to moisten.

Geistlich Bio-Oss® is packed in a double sterile barrier system consisting of a glass vial and an outer blister. Geistlich Bio-Oss is sterilized according to validated processes by y-irradiation.

Geistlich Bio-Oss Collagen® is a combination of purified spongiosa (cancellous) bone mineral granules (Geistlich Bio-Oss®) and 10% collagen fibers in a block form.

The collagen facilitates handling and application of Geistlich Bio-Oss Collagen® and acts to hold the Bio-Oss particles at the desired place. The consistency of this material readily allows to take the shape of the defect. The collagen component is resorbed after application.

Geistlich Bio-Oss Collagen® is intended for filling and augmentation of bony voids and gaps in maxillofacial surgery, implantology, and periodontology according to the intended use of the product.

Geistlich Bio-Oss Collagen® is serving as a matrix consisting of interconnected macroand micropores. The material is highly porous and has a large inner surface area.

Geistlich Bio-Oss Collagen®is a biocompatible bone mineral matrix and is manufactured from boyine bone and collagen from connective tissue of pigs certified for human consumption according to a controlled and validated multistage purification process. From the bovine bone all organic components are removed.

Due to the interconnected macro and microporous system the device is hydrophilic and easy to moisten.

Geistlich Bio-Oss Collagen® is packed in a double sterile barrier system consisting of an inner and an outer blister. Geistlich Bio-Oss® is sterilized according to validated processes by y-irradiation.

AI/ML Overview

The provided text describes devices (Geistlich Bio-Oss® and Geistlich Bio-Oss Collagen®) that are bone grafting materials. Instead of software, these are physical medical devices, and their acceptance criteria and evaluation method differ significantly from what would be expected for a software-based AI medical device.

Therefore, many of the typical questions for AI/ML device evaluations (such as sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for training) are not applicable to this type of device submission.

The "studies" described are bench tests comparing the new materials to previously cleared predicate devices using analytical methods.

Here's an interpretation of the relevant information provided:

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

The acceptance criteria for these bone grafting materials are based on demonstrating substantial equivalence to predicate devices through physicochemical characterization. The goal is to show that the new devices, particularly with raw material from an alternative geographic source, are identical in composition and structure to the existing, cleared versions of Geistlich Bio-Oss®.

Acceptance Criteria (Technological Characteristics)	Reported Device Performance (Geistlich Bio-Oss®)	Reported Device Performance (Geistlich Bio-Oss Collagen®)
Appearance	white granulate or white, porous block	white sponge-like, hard pieces of customized size
Moisture	less than 5% (w./w.)	less than 8% (w./w.)
Calcium	35%-40% (w./w.)	38%-42% (w./w.)
Phosphorous	13.5% - 18.5% (w./w.)	12.5% - 17.5% (w./w.)
X-ray Diffraction Analysis	Did not reveal any differences, confirmed crystalline hydroxyapatite.	Did not reveal any differences, confirmed crystalline hydroxyapatite.
Fourier Transform Infrared Spectroscopy (FTIR)	Data from new source equal to regular manufacturing lots.	Data from new source equal to regular manufacturing lots.
Mercury Intrusion Porosimetry	Porosity, specific pore surface area, bulk density, and bimodal pore size distribution identical to regular manufacturing lots.	Porosity, specific pore surface area, bulk density, and bimodal pore size of Geistlich Bio-Oss® component identical to regular manufacturing lots.

Study Information (Applicable to Physical Device Substantial Equivalence)

Sample size used for the test set and data provenance:
- The "test set" here refers to samples of the Geistlich Bio-Oss® and Geistlich Bio-Oss Collagen® products manufactured with raw material from an "alternative geographic source."
- These samples were compared against "standard manufacturing lots" of the devices.
- The exact number of samples or batches tested for each analytical method (X-ray diffraction, FTIR, Mercury Intrusion Porosimetry) is not specified in the provided text.
- Data provenance is manufacturing samples, not patient data.
Number of experts used to establish the ground truth for the test set and their qualifications:
- N/A. This is a physical device characterization, not an expert-driven diagnostic evaluation. Ground truth is established by validated analytical chemistry and materials science techniques.
Adjudication method for the test set:
- N/A. Not applicable for analytical comparisons. The methods produce quantitative or spectral data that are directly compared.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size:
- No. This is a comparison of physicochemical properties of a material, not a diagnostic or prognostic aid requiring human interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a material, not a software algorithm.
The type of ground truth used:
- The "ground truth" is based on the previously cleared predicate Geistlich Bio-Oss® and Geistlich Bio-Oss Collagen® products. The objective is to demonstrate that the devices produced with raw material from an alternative geographic source are identical in their critical physicochemical characteristics to the predicate versions already accepted by the FDA. This is established through:
  - Validated analytical chemistry techniques (X-ray diffraction, FTIR).
  - Materials science techniques (Mercury Intrusion Porosimetry).
  - Gravimetric analysis (moisture, calcium, phosphorous content).
The sample size for the training set:
- N/A. Not applicable for this type of device and evaluation. There is no machine learning model being "trained."
How the ground truth for the training set was established:
- N/A. Not applicable.

Summary

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510(k) Summary

FEB 1 5 2013

GEISTLICH BIO-OSS®

SPONSOR

Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland

Contact Person:

E-mail: Phone: Fax: Date Prepared: Daniel Kracov, Arnold & Porter, LLP Counsel to Geistlich Pharma AG Daniel.Kracov@aporter.com 202-942-5120 202-942-5999 February 13, 2013

DEVICE NAME

Proprietary Name:	Geistlich Bio-Oss®
Common/Usual Names:	Bone Grafting Material
Classification Name:	Bone grafting material, animal source (NPM)

PREDICATE DEVICES

Geistlich Bio-Oss® and Geistlich Bio-Oss® Blocks (K112572, K033815, K970321, K952618)

DEVICE DESCRIPTION

Geistlich Bio-Oss® is serving 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 a biocompatible bone mineral matrix and is manufactured from bovine bone in a validated multistage purification process to remove the organic components.

Due to the interconnected macro and microporous system the device is hydrophilic and easv to moisten.

{1}------------------------------------------------

Geistlich Bio-Oss® is packed in a double sterile barrier system consisting of a glass vial and an outer blister. Geistlich Bio-Oss is sterilized according to validated processes by y-irradiation. It is available in the following sizes and amounts:

Product	Weight	Particle Size
Geistlich Bio-Oss® spongiosa (cancellous) granules	0.25 g	0.25 - 1.0 mm
Geistlich Bio-Oss® spongiosa (cancellous) granules	0.5 g	0.25 - 1.0 mm
Geistlich Bio-Oss® spongiosa (cancellous) granules	2.0 g	0.25 - 1.0 mm
Geistlich Bio-Oss® spongiosa (cancellous) granules	5.0 g	0.25 - 1.0 mm
Geistlich Bio-Oss® spongiosa (cancellous) granules	0.5 g	1.0 - 2.0 mm
Geistlich Bio-Oss® spongiosa (cancellous) granules	2.0 g	1.0 - 2.0 mm

Geistlich Bio-Oss® spongiosa (cancellous) block

1 x 1 x 2 cm (approx.)

INTENDED 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

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

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

Appearance: white granulate or white, porous block

Moisture: less than 5% (w./w.)

Calcium: 35%-40% (w.lw.)

Phosphorous: 13.5% - 18.5% (w./w.)

SUMMARY OF DATA TO SUPPORT SUBSTANTIAL EQUIVALENCE

Geistlich Bio-Oss® from standard manufacturing lots was compared with Geistlich Bio-Oss® manufactured with the raw material from the alternative geographic source by means of X-ray diffraction analysis, Fourier Transform Infrared Spectroscopy and Mercury Intrusion Porosimetry.

The X-ray spectra of Geistlich Bio-Oss® manufactured with bovine bone from the alternative geographic source did not reveal any differences and confirmed that Geistlich Bio-Oss® is crystalline hydroxyapatite with no detectable impurities.

{2}------------------------------------------------

Fourier Transform Infrared Spectroscopy data was generated to determine the molecule structure characteristics of Geistlich Bio-Oss®. The data from regular manufacturing lots were equal to Geistlich Bio-Oss® manufactured from bovine bone of the alternative geographic source.

Mercury Intrusion Porosimetry revealed that porosity, specific pore surface area, bulk density and bimodal pore size distribution demonstrates that the micro and macro pores of Geistlich Bio-Oss® from regular manufacturing lots are identical to Geistlich Bio-Oss® manufactured from bovine bone of the alternative geographic source.

CONCLUSION

Results of the bench tests support that Geistlich Bio-Oss® is Substantially Equivalent to the identified predicate devices.

{3}------------------------------------------------

510(k) Summary

GEISTLICH BIO-OSS COLLAGEN®

SPONSOR

Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland

Contact Person:	Daniel Kracov, Arnold & Porter, LLPCounsel to Geistlich Pharma AG
E-mail:	Daniel.Kracov@aporter.com
Phone:	202-942-5120
Fax:	202-942-5999
Date Prepared:	February 13, 2013

DEVICE NAME

Proprietary Name:	Geistlich Bio-Oss Collagen®
Common/Usual Names:	Bone Grafting Material Plus Collagen
Classification Name:	Bone grafting material, animal source (NPM)

PREDICATE DEVICES

Geistlich Bio-Oss Collagen® (K112572, K092428, K033815, K974399)

DEVICE DESCRIPTION GBOC

Geistlich Bio-Oss Collagen® is a combination of purified spongiosa (cancellous) bone mineral granules (Geistlich Bio-Oss®) and 10% collagen fibers in a block form.

Geistlich Bio-Oss Collagen® is intended for filling and augmentation of bony voids and gaps in maxillofacial surgery, implantology, and periodontology according to the intended use of the product.

Geistlich Bio-Oss Collagen® is serving as a matrix consisting of interconnected macroand micropores. The material is highly porous and has a large inner surface area.

60123676v1

{4}------------------------------------------------

Due to the interconnected macro and microporous system the device is hydrophilic and easy to moisten.

Single Products:

1 block 100 mg Geistlich Bio-Oss® spongiosa (cancellous) granules and 10% collagen .
1 block 250 mg Geistlich Bio-Oss® spongiosa (cancellous) granules and 10% collagen .
1block 500 mg Geistlich Bio-Oss® spongiosa (cancellous) granules and 10% collagen .

Convenience Kits:

Geistlich Combi-Kit Collagen® .
- 1 block 100 mg Geistlich Bio-Oss® spongiosa (cancellous) granules and 10% collagen, and 1 Geistlich Bio-Gide® membrane, 16 x 22 mm
Geistlich Perio System Combi-Pack . 1 block 100 mg Geistlich Bio-Oss® spongiosa (cancellous) granules and 10% collagen, and 1 Geistlich Bio-Gide® Perio membrane, 16 x 22 mm

INTENDED USE

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).

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

Appearance: white sponge-like, hard pieces of customized size

60123676v1

{5}------------------------------------------------

Water: less than 8% (w./w.) Calcium: 38%-42% (w./w.) Phosphorous: 12.5% - 17.5% (w./w.)

SUMMARY OF DATA TO SUPPORT SUBSTANTIAL EQUIVALENCE

Geistlich Bio-Oss® from standard manufacturing lots was compared with Geistlich Bio-Oss manufactured with the raw material from the alternative geographic source by means of X-ray diffraction analysis, Fourier Transform Infrared Spectroscopy and Mercury Intrusion Porosimetry.

The X-ray spectra of Geistlich Bio-Oss® manufactured from bovine bone of the alternative geographic source did not reveal any differences and confirmed that Geistlich Bio-Oss® is crystalline hydroxyapatite with no detectable impurities.

Fourier Transform Infrared Spectroscopy data was generated to determine the crystal structure, crystal size and molecule structure characteristics of Geistlich Bio-Oss® The data from reqular manufacturing lots were equal to Geistlich Bio-Oss® manufactured from bovine bone of the alternative geographic source.

Mercury Intrusion Porosimetry revealed that porosity, specific pore surface area, bulk density and bimodal pore size of Geistlich Bio-Oss® from regular manufacturing lots are identical to Geistlich Bio-Oss® manufactured from bovine bone of the alternative geographic source.

CONCLUSION

Geistlich Bio-Oss Collagen® is Substantially Equivalent to the identified predicate devices.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure with three curved lines representing wings or streams.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 15, 2013

Geistlich Pharma AG C/O Mr. Daniel A. Kracov Arnold & Porter, Limited Liability Partnership 555 Twelfth Street, North West WASHINGTON DC 20004-1206

Re: K122894

Trade/Device Name: Geistlich Bio-Oss® and Geistlich Bio-Oss Collagen® Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPM Dated: January 31, 2013 Received: February 1, 2013

Dear Mr. Kracov:

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 (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. 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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Page 2 - Mr. Kracov

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mary S. Runner

Susan Runner, DDS, MA 2013.02.21

13:27:34 -05'00'

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and

Dental Devices

Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

{8}------------------------------------------------

Indications for Use

K122894 510(k) Number (if known): (not yet known)

Device Name: Geistlich Bio-Oss®

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

AND/OR Prescription Use × CFR 801 Subpart D) (21 CFR 801 Subpart C) Over-The-Counter Use_ (Part 21

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Division Control, Dental Devices

510(k) Number;

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.