· Defects after removal of bone cysts
· Augmentation of the atrophied alveolar ridge
· Sinus lift and sinus floor elevation (subantral augmentation)
· Filling of alveolar defects following tooth extraction for alveolar ridge preservation
· Filling of extraction defects to create an implant bed
· Filling of two- or multi-walled infrabony pockets, and bi- and trifurcation defects
· Support function for a membrane in controlled tissue regeneration (CTR)
· Defects after surgical removal of retained teeth or corrective osteotomies
· Other multi-walled bone defects of the alveolar processes.

Device Description

Osbone® DENTAL is an open-cellular, synthetic bioceramic for bone regeneration. It is comprised of a pure phase hydroxyapatite with an open sintering structure resulting in a biocompatible, bioactive and osteoconductive biomaterial. Osbone® DENTAL morsels are open-cellular highly porous morsels, ranging from 150-8000 um for filling bone defects in dental procedures. While Osbone® DENTAL can be manufactured with a granule size of up to 8000 um, curasan will only market granule sizes of 0.25-2.0 mm, which is within the size range of the predicate devices. The high porosity helps to accelerate ingrowth of bone.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for Osbone® DENTAL:

1. Table of Acceptance Criteria and Reported Device Performance

The submission for Osbone® DENTAL is a 510(k) premarket notification, which establishes substantial equivalence to predicate devices rather than proving a device meets specific, pre-defined quantitative acceptance criteria in a clinical study. Therefore, the "acceptance criteria" here are based on demonstrating that Osbone® DENTAL is as safe and effective as its predicates.

Feature	Osbone® DENTAL Performance (as claimed)	Comparison to Predicate Devices (Implied Acceptance)
Intended Use	Multi-walled bone defects, alveolar ridge augmentation, sinus lift, extraction socket filling, infrabony pockets, CTR support, defects after retained teeth removal/osteotomies.	"Identical to the predicate devices" (Summary Section 6), and the comparison table shows highly overlapping indications for use across all predicates. Acceptance implies the indications are substantially equivalent.
Principles of Operation	Morsel size selection, mixing with autologous bone, application to graft bed, porous structure for bone ingrowth.	"Identical to the predicate devices" (Summary Section 6). Acceptance implies the fundamental mechanism of action is consistent with existing devices.
Technological Characteristics (Form)	Granules	Similar to Bio-Oss, Endobon (granular form available), and OsteoGraf/D. Acceptance implies the form factor is not a significant difference.
Technological Characteristics (Material)	Pure phase hydroxyapatite, synthetic, open-cellular bioceramic	Similar to OsteoGraf/D (synthetic HA) and Bio-Oss/Endobon (bovine bone-derived HA). The submission argues the differences (synthetic vs. bovine) do not impact safety/efficacy. Acceptance hinges on this argument being sufficient.
Technological Characteristics (Granule Size)	0.25-2.0 mm (marketed range); open-cellular, highly porous. Specific marketed sizes: 0.25-1.0 mm, 1.0-2.0mm.	Sizes fall within the range of predicate devices (Bio-Oss: 0.25-2.0 mm; Endobon: 0.5-2.0 mm; OsteoGraf/D: 0.25-0.42 mm). "Differences... are limited to minor differences in granule size... that do not impact safety and efficacy." Acceptance requires that these minor differences are deemed non-critical.
Technological Characteristics (Porosity)	$80 \pm 5%$ (material); $75 \pm 5%$ (granular form). Open cellular, highly porous.	Comparable to Bio-Oss (75-80%) and Endobon (45-85%). "The size and porosity of the Osbone® DENTAL granules (morsels) that curasan intends to market are within the range of the size and porosity of the predicate devices." Acceptance based on being within predicate range.
Resorption	Partially resorbable. Extremely slow resorption kinetics due to high-temperature sintered HA.	Compared to Bio-Oss (Partially resorbable) and OsteoGraf/D ("Essentially non-resorbable"). The submission argues the "resorption characteristics of the proposed and predicate devices are essentially identical" despite terminology differences. Acceptance implies this justification is satisfactory.
Biocompatibility	Established (non-clinical testing, in compliance with ASTM F1185-03, ISO 13779-1, FDA guidance).	Expected to be equivalent to established predicates. Acceptance is based on meeting recognized standards for synthetic HA and the general understanding that HA is biocompatible.
Sterility	Sterile, non-pyrogenic, single patient use.	Similar to all predicate devices. Acceptance requires demonstration of standard sterilization and freedom from pyrogens.
Mechanical Characteristics	Does not impart mechanical strength to surgical site.	Similar to Bio-Oss. Consistent with the typical understanding of bone void fillers not being load-bearing. Acceptance assumes this functional characteristic is understood and similar to relevant predicates.
Safety and Effectiveness	Supported by materials characterization data, biocompatibility information, and history of safe clinical use for HA products.	The overall "acceptance criterion" for a 510(k) is substantial equivalence in terms of safety and effectiveness. The report concludes that Osbone® DENTAL is substantially equivalent to the predicates.

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

Sample Size for Test Set: Not applicable. This submission is for a 510(k) premarket notification and relies on demonstrating substantial equivalence to existing devices, primarily through non-clinical testing and comparison of technological characteristics. No clinical testing was submitted in support of this 510(K) premarket notification (Section 9).
Data Provenance: Not applicable for a clinical test set. Non-clinical data (materials characterization, biocompatibility) are derived from in-vitro testing and product specification analyses of Osbone® DENTAL, conducted by curasan AG (Germany).

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

Not applicable, as no clinical test set requiring expert-established ground truth was used for this submission. The "ground truth" for substantial equivalence is derived from the established safety and effectiveness of the legally marketed predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set or human reader evaluation was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This device is a synthetic bone void filler and not an AI-powered diagnostic or assistive technology.

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

Not applicable. This device is a physical medical implant, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the established safety and effectiveness of the identified predicate devices (BIO-OSS, Endobon, OsteoGraf/D). The submission makes its case by demonstrating that Osbone® DENTAL shares the same indications for use, principles of operation, and technological characteristics, and that any minor differences do not impact safety or efficacy. The "truth" is therefore based on regulatory precedent and a detailed comparison against accepted standards and devices.

8. The Sample Size for the Training Set

Not applicable, as no algorithm or machine learning model was developed or trained for this device.

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

Not applicable, as no algorithm or machine learning model was developed or trained for this device.

Summary

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510(k) Summary Osbone® DENTAL

1. SUBMITTER/510(K) HOLDER

curasan AG Lindigstrasse 4 63 801 Kleinostheim Germany

Contact Person:	Dr. Wolf-Dietrich Hübner
Telephone:	+49-6027-40900-0

Date Prepared: January 6, 2011

2. DEVICE NAME

Trade Name:	Osbone® DENTAL
Common Name:	Synthetic bone void filler
Classification Name:	Bone grafting material, synthetic

3. PREDICATE DEVICES

· BIO-OSS ~ Ceramic Pure Natural Hydroxyapatite (Geistlich-Pharma, K873763)
· Endobon (BIOMET, Inc., K980679)
· OsteoGraf/D (DentSply, K072056)

4. DEVICE DESCRIPTION

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5. INDICATIONS FOR USE

Osbone® DENTAL is intended for the filling and reconstruction of multi-walled bone defects, e.g .:

Defects after removal of bone cysts .
Augmentation of the atrophied alveolar ridge .
Sinus lift and sinus floor elevation (subantral augmentation)
. Filling of alveolar defects following tooth extraction for alveolar ridge preservation
. Filling of extraction defects to create an implant bed
Filling of two- or multi-walled infrabony pockets, and trifurcation defects .
. Support function for a membrane in controlled tissue regeneration (CTR)
. Defects after surgical removal of retained teeth or corrective osteotomies
. Other multi-walled bone defects of the alveolar processes.

6. PRINCIPLES OF OPERATION

The principles of operation for the proposed Osbone® DENTAL are identical to the predicate devices. The morsel size is selected based on the size of the defect to be filled. If desired, the morsels may be mixed with premorselized autologous bone. The bone void filler is then applied to the prepared graft bed. The porous structure of the material makes it possible for the bone cells to grow into the matrix.

7. TECHNOLOGICAL CHARACTERISTICS

Both the proposed Osbone® DENTAL and the predicate devices are supplied in granular form. The size and porosity of the Osbone® DENTAL granules (morsels) that curasan intends to market are within the range of the size and porosity of the predicate devices.

Osbone® DENTAL is similar in material composition to the predicate devices Bio-Oss, Endobon and OsteoGraf/D. Both the proposed and predicate devices are composed of hydroxyapatite. The proposed Osbone® DENTAL and the predicate DentSply devices are chemically synthesized. The Bio-Oss and Endobon predicates are prepared from bovine bone.

The proposed Osbone® DENTAL and the predicate devices all undergo a minor amount of resorption, like any material implanted in the body. Degradation and resorption in the context of bone void fillers means that the released ions are

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phagocytosed or metabolized while the nascent space becomes filled by bone. As compared to bone void fillers composed of ß-TCP, the degree of resorption is negligible for bone void fillers made from hydroxyapatite due to the extremely slow resorption kinetics of high-temperature sintered hydroxyapatite. Therefore, while the term used to describe the extent of resorption for the proposed and predicate devices may be different, curasan considers that the resorption characteristics of the proposed and predicate devices are essentially identical.

8. NON-CLINICAL TESTING

Osbone® DENTAL is chemically synthesized to form a hydroxyapatite open-cellular bioceramic. Osbone® DENTAL complies with the following standards:

. ASTM F1185-03, "Specification for Composition of Hydroxyapatite for Surgical Implants"
. 13779-1, "Implants for surgery: Hydroxyapatite Part 1: Ceramic ISO hydroxyapatite."

The material was analyzed to obtain the information specified in FDA's "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices" (April 28, 2005).

9. CLINICAL TESTING

No clinical testing was submitted in support of this 510(k) premarket notification.

10. CONCLUSIONS

Osbone® DENTAL shares the same indications for use, principles of operation and technological characteristics as the predicate devices BIO-OSS - Ceramic Hydroxyapatite (subject of K873763), Endobon (subject of K980679) and OsteoGraf/D (subject of K072056). Differences between the proposed and predicate devices are limited to minor difference in granule size and porosity that do not impact the safety and efficacy of the device.

curasan believes that the materials characterization data compiled for Osbone® DENTAL, along with the biocompatibility information and the history of safe clinical use for hydroxyapatite products supports the safety and effectiveness of the proposed Osbone® DENTAL for its intended use as a dental bone void filler. Therefore, curasan AG believes that the proposed Osbone® DENTAL dental bone void filler is substantially equivalent to the Bio-Oss, Endobon, and OsteoGraf/D devices.

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Regulatory Status	Osbone® DENTAL	Geistlich-PharmaBio-Oss	BIOMET, Inc.Endobon	DentSplyOsteoGraf/D
Intended Use	ProposedOsbone® DENTAL is intended for the filling and reconstruction ofmulti-walled bone defects, e.g.:• Defects after removal of bone cysts• Augmentation of the atrophied alveolar ridge• Sinus lift and sinus floor elevation (subantral augmentation)• Filling of alveolar defects following tooth extraction for alveolarridge preservation• Filling of extraction defects to create an implant bed• Filling of two- or multi-walled infrabony pockets, and bi- andtrifurcation defects• Support function for a membrane in controlled tissue regeneration(CTR)• Defects after surgical removal of retained teeth or correctiveosteotomies• Other multi-walled bone defects of the alveolar processes	Filling of bone defects and boneaugmentation, e.g.:• Augmentation/reconstruction ofalveolar ridges• Filling of extraction sockets• Implantology: preparation ofimplant sites, filling of bonedehiscences, and sinus flooraugmentations• Periodontology: filling of bonedefects, support of the membraneduring guided tissue regeneration(GTR)	Used in the following dentaland/or oral surgical procedures:• Alveolar ridgeaugmentation/reconstruction• Filling of resection defects inbenign bone tumor, bonecysts, or other defects in thealvcolar ridge or wall• Filling of periodontal bonepockets in the jaw (granules I)• Filling bone defects afterapicetomy• Filling alveoli after toothextraction	Treatment of intrabonyperiodontal defects,augmentation of bony defectsin the alveolar ridge, andfilling of extraction sites.
Performance	Osteoconductive	Osteoconductive	Osteoconductive	Information not available
Source	Synthetic	Bovine bone	"Bovinous bone"	Synthetic
Composition	100% HA	Cancellous bone	99% HA, 1-2% CaO andNaCaPO4	100% HA
Form	Granules	Granules	Granules and Blocks/Cylinders	Granules
Granule size	0.25-1.0 mm, 1.0-2.0mm	0.25-1.0 mm, 1.0-2.0 mm	0.5-1.0 mm, 1.0-2.0 mm	0.25-0.42 mm
Porosity	$80\pm5%$ *	75-80%	45-85%	None
Resorption	Partially resorbable	Partially resorbable	None	"Essentially non-resorbable"
Sterility	Sterile. Non-pyrogenicSingle patient use	Sterile, Non-pyrogenicSingle patient use	Sterile, Single patient use	Sterile, single patient use
Biocompatibility	Established	Established	Established	Established
Mechanicalcharacteristics	Does not impart mechanical strength to surgical site	Does not impart mechanical strengthto surgical site	Information not available	Information not available
HA = Hydroxyapatite* In granular form (after crushing) 75±5%

DMPARISON TABLE FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCI

curasan AG
Additional Information – K102872

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular arrangement of text surrounding a stylized emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular fashion. The emblem features a stylized representation of an eagle or bird-like figure with three distinct, curved lines forming its body and wings.

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

Curasan AG C/O Cynthia J. M. Nolte. PhD Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

JAN 1 2 2011

Re: K102872

Trade/Device Name: Osbone® Dental Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: January 6, 2011 Received: January 10, 2011

Dear Dr. Nolte:

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. Register

the country of the county of the

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Page 2 – Dr. Nolte

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 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.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

JAN 1 2 2011

K102872 510(k) Number:

Osbone® DENTAL Device Name:

Indications for Use:

Osbone® DENTAL is intended for the filling and reconstruction of multi-walled bone defects, e.g .:

· Defects after removal of bone cysts
· Augmentation of the atrophied alveolar ridge
· Sinus lift and sinus floor elevation (subantral augmentation)
· Filling of alveolar defects following tooth extraction for alveolar ridge preservation
· Filling of extraction defects to create an implant bed
· Filling of two- or multi-walled infrabony pockets, and bi- and trifurcation defects
· Support function for a membrane in controlled tissue regeneration (CTR)
· Defects after surgical removal of retained teeth or corrective osteotomies
· Other multi-walled bone defects of the alveolar processes.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence or SDRH, Office of Device Evaluation (ODE)

Susan Vanoye

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

510(k) Number: K102822

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.