Osseolive® DENTAL is indicated for applications in oral and maxillofacial surgery and dentistry, including filling and/or reconstruction of multi-walled (artificial or degenerative) bone defects, e.g.:

Defects after the extirpation of bone cysts .
Augmentation of an atrophied alveolar ridge ●
Sinus lift or sinus floor elevation (subantral augmentation) ●
Filing of alveolar defects after tooth extraction for preservation of the alveolar ridge
Filling of extraction defects to create an implant bed .
Filling of two- or multi-walled bone pockets as well as the bi- and trifurcation defects .
. Defects after operative removal of retained teeth or corrective osteotomies

Device Description

Osseolive® DENTAL is a synthetic absorbable radiopaque silicated calcium-alkali-phosphate ceramic for filling, bridging and reconstructing bone defects and for bone fusion in dental and maxillofacial applications. Osseolive® DENTAL has an open-cellular porosity of about 80% and is available as polygonal granyles of various grain sizes. It is resorbed by the body over a period of months and simultaneously substituted by local autologous bone. As a synthetic, bioactive ceramic material Osseolive® DENTAL has excellent intra- and extra-osseous tissue compatibility and is neither locally nor systemically toxic. Osseolive® DENTAL is a calcium-sodium phosphate with an open sintered structure. Osseolive® DENTAL morsels are highly porous, available in different grain size fractions between 150 and 2000 um. The high porosity allows blood components and body fluids to penetrate the material rapidly and unhindered. The chemical composition is a modification of tricalcium phosphate, where one calcium atom is replaced by one potassium atom and one sodium atom, resulting in increased solubility. Doping this glass ceramic with 4% sodium-magnesium-silicate on interstitial positions ensures the maximum mechanical stability. Osseolive® DENTAL has a resorption time of 3 to 12 months. Osseolive® DENTAL morsels are packaged for sale in glass vials.

AI/ML Overview

The provided text includes a 510(k) summary for Osseolive® DENTAL, which is a dental bone grafting material. The document primarily focuses on establishing substantial equivalence to predicate devices through bench testing of material characteristics.

Here's an analysis of the requested information based only on the provided text:

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

The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics in the way a clinical study would for efficacy. Instead, it describes a "comparison summary" indicating that the majority of device characteristics are "similar to one or more of the predicate devices." Where differences exist, they "have no significant effect on device safety or effectiveness."

The "reported device performance" is presented as a list of material characteristics that were assessed, rather than specific numerical results against predefined criteria.

Acceptance Criterion (Implicit)	Reported Device Performance (as stated)
Device characteristics similar to predicate devices.	"The majority of the device characteristics for Osseolive® DENTAL are similar to one or more of the predicate devices."
Differences from predicate devices have no significant effect on safety or effectiveness.	"Where they are not similar, the differences have no significant effect on device safety or effectiveness."
Inorganic elements analysis	Assessed
Bulk density and porosity (according to USP 34 <616>)	Assessed
X-ray characterization	Assessed
FTIR characterization	Assessed
Crystallinity characterization	Assessed
Phase analyses	Assessed
Specific surfaces (B.E.T. method, ASTM C 1251 & D 4780)	Assessed
Micro structure characterization (ISO 6474 & ASTM E 112)	Assessed
Ca/P ratio per mass test material	Assessed
Identification/qualification of degradation products (DIN EN ISO 10993-14)	Assessed
pH value (USP 34 <791>)	Assessed

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

The document describes a "Bench test summary" performed by a "GLP compliant third party test laboratory." It assesses material characteristics. However, no specific sample sizes for the test set are mentioned. The provenance of the data is that it was conducted by a third-party lab, and the manufacturer is based in Germany. It's a bench test (laboratory testing), not a clinical study on patients, so concepts like retrospective/prospective or country of origin for patient data are not applicable here.

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)

This is not applicable to the data provided. The study is a series of bench tests on material characteristics, not an assessment requiring expert interpretation of clinical data or images to establish ground truth.

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

This is not applicable to the data provided. As explained above, this was a bench test on material properties, not a clinical assessment requiring adjudication of observer findings.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The submission is for a material (bone graft), not an AI-powered diagnostic device, so this type of study is not relevant to the provided text.

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

This is not applicable as the device is a bone grafting material, not an algorithm.

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

For the bench tests, the "ground truth" would be the established scientific and engineering standards and methods used to measure the material properties (e.g., USP 34 <616> for bulk density, ASTM C 1251 for specific surfaces). These are physical measurements, not clinical diagnoses or expert consensus.

8. The sample size for the training set

This is not applicable. The submission describes a device that is a material product, not an algorithm that requires a training set.

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

This is not applicable for the same reason as point 8.

Summary

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Osseolive® DENTAL 510(k)

Appendix B

510(k) Summary in accordance with 21 CFR 807.92(c)

Device Name:

Osseolive® DENTAL

Abbreviated

15 April 2011

Curasan AG. Frankfurt Facility Ernst-Wiss-Strasse 18 65933 Frankfurt Germany

3004847139

Curasan AG Lindigstrasse 4 63801 Kleinostheim

3003771570

Mr Roger Gray

Piazza Albania 10 00153 Rome

Phone: +49 (0)60 27 40 900 0

VP Quality and Regulatory Donawa Lifescience Consulting

+49 (0)60 27 40 900 29

+39 06 578 2665

+30 06 574 3786

Dental Bone Grafting Material

Glass ceramic bone grafting material

Bone grafting material is a material such as hydroxyapatite,

Class II Special Controls Guidance Document: Dental Bone

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.

rgray@donawa.com

Germany

Fax:

Italy

Fax:

LYC

872.3930

Dental

Class II

Email:

Phone:

Type of 510{k} submission:

Date of Submission:

Manufacturer:

FDA Registration Number:

510(k) Owner:

FDA Registration Number:

510(k) Submitter and Contact:

FDA Classification Name: Common Name: FDA Panel: FDA Classification:

FDA Regulation Number:

FDA Product Code:

FDA Identification:

FDA Guidance Applied:

FDA Guidance Applied:

510(k) for Osseolive® DENTAL

Appendix B

Grafting Material Devices

DEC 2 0 2012

U CLT.

1111105

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Image /page/1/Picture/1 description: The image shows the word "curasan" in bold, black letters. The font is sans-serif and the letters are closely spaced together. The word appears to be a logo or brand name.

Indications for Use:

Osseolive® DENTAL is indications in oral and maxillofacial surgery and dentistry, including filling and/or reconstruction of multi-walled (artificial or degenerative) bone defects, e.g .:

Defects after the extirpation of bone cysts .
Augmentation of an atrophied alveolar ridge ●
Sinus lift or sinus floor elevation (subantral augmentation) ●
Filing of alveolar defects after tooth extraction for preservation of the alveolar ridge �
Filling of extraction defects to create an implant bed .
Filling of two- or multi-walled bone pockets as well as the bi- and trifurcation defects .
. Defects after operative removal of retained teeth or corrective osteotomies

Technological and Performance Characteristics:

Description

Osseolive® DENTAL has an open-cellular porosity of about 80% and is available as polygonal granyles of various grain sizes. It is resorbed by the body over a period of months and simultaneously substituted by local autologous bone. As a synthetic, bioactive ceramic material Osseolive® DENTAL has excellent intra- and extra-osseous tissue compatibility and is neither locally nor systemically toxic.

Osseolive® DENTAL is a calcium-sodium phosphate with an open sintered structure. Osseolive® DENTAL morsels are highly porous, available in different grain size fractions between 150 and 2000 um. The high porosity allows blood components and body fluids to penetrate the material rapidly and unhindered.

The chemical composition is a modification of tricalcium phosphate, where one calcium atom is replaced by one potassium atom and one sodium atom, resulting in increased solubility.

Doping this glass ceramic with 4% sodium-magnesium-silicate on interstitial positions ensures the maximum mechanical stability.

Osseolive® DENTAL has a resorption time of 3 to 12 months.

Osseolive® DENTAL morsels are packaged for sale in glass vials.

Predicate Device Comparison:

The predicate devices selected for comparison with Osseolive® DENTAL are identified as follows:

Device:	PerioGlas
510(k) Sponsor:	NovaBone Products, LLC
510(k) Number:	K053387
Clearance Date:	14 February 2006
FDA Product Code:	LYC
Classification Name:	Bone grafting material, synthetic
Regulation No:	872.3930

Device:	Ceracell® DENTAL
510(k) Sponsor:	Curasan AG
510(k) Number:	K103709
Clearance Date:	10 March 2011
FDA Product Code:	LYC
Classification Name:	Bone grafting material, syntheti

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Image /page/2/Picture/1 description: The image shows the word "curasan" in a bold, sans-serif font. The letters are all lowercase and are closely spaced together. The word appears to be printed in black ink on a white background, creating a high contrast image.

Regulation No: ...............................................................................................................................................................

Device:	Cerasorb® M DENTAL
510(k) Sponsor:	Curasan AG
510(k) Number:	K051443
Clearance Date:	22 July 2005
FDA Product Code:	LYC
Classification Name:	Bone grafting material, synthetic
Regulation No:	872.3930

Bench test summary:

Comparative testing of the subject device and predicate devices was undertaken by a GLP compliant third party test laboratory. The following material characteristics were assessed for each device for comparison purposes:

Analyses of inorganic elements .
Determination of bulk density according to USP 34 <616> and porosity .
X-rav characterization .
FTIR characterization ●
Characterization of crystallinity ●
Phase analyses ●
Determination of the specific surfaces (B.E.T. method) according to ASTM C 1251 and ● ASTM D 4780
Micro structure characterization according to ISO 6474 and ASTM E 112 .
Determination of Ca/P ratio per mass test material .
Identification and qualification of degradation products according to DIN EN ISO 10993-14 .
Determination of the pH value according to USP 34 <791> �

Comparison summary:

The majority of the device characteristics for Osseolive® DENTAL are similar to one or more of the predicate devices. Where they are not similar, the differences have no significant effect on device safety or effectiveness.

Conclusion:

Based on the information contained within this submission, it is concluded that the Osseolive® DENTAL is substantially equivalent to the identified predicate devices already in interstate commerce within the USA.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines below it, representing the American people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

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

December 20, 2012

Curasan AG C/O Mr. Roger Gray Vice President Quality and Regulatory Donawa Lifescience Consulting SRL Piazze Albania 10 Rome, Italy 00153

Re: K111105

Trade/Device Name: Curasan Osseolive® DENTAL Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: December 14, 2012 Received: December 17, 2012

Dear Mr. Gray:

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. Gray

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/ReportalProblem/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,

Anthong Lo minta

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

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Appendix A

Indications for Use Statement

510(k) Number (if known): K111105

Device Name: Curasan Osseolive® DENTAL

Indications for Use: Osseolive® DENTAL is indicated for applications in oral and maxillofacial surgery and dentistry, including filling and/or reconstruction of multiwalled thereful ourgery and dentisury, including filling a
walled (artificial or degenerative) bone defects, e.g.:

Defects after the extirpation of bone cysts .
Augmentation of an atrophied alveolar ridge ●
Sinus lift or sinus floor elevation (subantral augmentation) .
Filling of also are of ordtion (Subantral augmentation)
Filling of alveolar defects after tooth extraction for preservation of the alveolar
ridge .
Filling of extraction defects to create an implant bed ● ●
Filing of two- now don'to create an implant bed
Filing of two- or multi-walled bone pockets as well as the bi- and trifurcation
defects
Defects after operative removal of retained teeth or corrective osteotomies

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner DDS, MA
2012.12.20
06:52:57 -05'00'

(Division Sign-Off) (Division of Anestheslology, General Hospital Infection Control, Dental Devices

Kili 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.