Augmentation or reconstructive treatment of the alveolar ridge
Filling of infrabony periodontal defects .
Filling of defects after root resection, apicoectomy, and cystectomy
Filing 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)
Filling of perio-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)

Device Description

Ceracell® DENTAL is a synthetic absorbable radiopaque bio-ceramic for dental and maxillofacial bone regeneration, using pure phase beta-tricalcium phosphate with an open-cell sintered structure of biocompatible, bioactive organic and osteoconductive material.

Ceracell® DENTAL polygonal 'morsels' have a porosimately 80% and are available in a grain sizes from 150 - 2,000 µm, with the intended use of filling dental and maxillofacial bone defects. This level of porosity allows rapid ingrowth of the bone, and blood components are able to permeate the material, leading to osseous integration and vascularisation.

The material is doped with 4% sodium-magnesium-silicate to provide mechanical stability.

Ceracell® DENTAL morsels are available in a range of morsel sizes and quantities.

The final product is packed in glass vials, fitted with brombuty rubber stoppers, then subjected to a gamma radiation sterilization process before being packed in outer cartons.

Resorption time varies with technique from 4 to 12 months.

AI/ML Overview

The provided FDA 510(k) clearance letters and summary are for a bone grafting material, Ceracell® DENTAL. These documents primarily focus on demonstrating substantial equivalence to a legally marketed predicate device (Cerasorb® Dental) rather than establishing new performance criteria through a detailed clinical study with acceptance criteria.

Therefore, the information required to populate all sections of your request (e.g., acceptance criteria, test set sample size, number of experts for ground truth, MRMC study results, training set details) is largely absent from these specific 510(k) documents. This is typical for a 510(k) submission for this type of device, where performance is often demonstrated through material characterization, biocompatibility testing, and comparison of technological characteristics to a predicate device, rather than extensive clinical efficacy trials with specific performance metrics defined by acceptance criteria in the way one might see for an AI/software device.

However, I can extract the available relevant information and explain what is not provided based on the nature of the submission.

Here is a breakdown of the requested information:

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

Acceptance Criteria (Explicitly Stated in Document)	Reported Device Performance (as per 510(k) Summary)
Substantial Equivalence: Device safety and effectiveness are substantially equivalent to the predicate device, Cerasorb® Dental (K051443).	The majority of device characteristics for Ceracell® DENTAL are identical to Cerasorb® Dental. Where not identical (device composition, volumetric porosity, phase purity), they are very similar, and these differences have no significant effect on device safety or effectiveness.
Biocompatibility: Device must be biocompatible.	Ceracell® DENTAL is described as having an "open-cell sintered structure of biocompatible, bioactive organic and osteoconductive material." (Implied to meet general biocompatibility standards).
Sterilization: Device must be terminally sterilized effectively.	"The final product is packed... then subjected to a gamma radiation sterilization process." (Implied to meet sterilization standards).
Porosity: Suitable for bone ingrowth.	"polygonal 'morsels' have a porosity of approximately 80%... This level of porosity allows rapid ingrowth of the bone, and blood components are able to permeate the material, leading to osseous integration and vascularisation."
Resorption Time: Appropriate for a bone grafting material.	"Resorption time varies with technique from 4 to 12 months."
Material Composition: Consistent with known safe and effective bone grafting materials.	"pure phase beta-tricalcium phosphate with an open-cell sintered structure... doped with 4% sodium-magnesium-silicate." (Compared to predicate, which also uses tricalcium phosphate).
Mechanical Stability: Sufficient for intended use.	"doped with 4% sodium-magnesium-silicate to provide mechanical stability."

Critically, for this type of device, explicit quantitative "acceptance criteria" for clinical performance metrics (like sensitivity, specificity, accuracy, etc., which are common for AI/diagnostic devices) are not provided in these documents. The primary "acceptance criterion" for a 510(k) is often demonstrating substantial equivalence to a predicate, which usually involves comparing technological characteristics and showing that any differences do not raise new questions of safety or effectiveness.

2. Sample sized used for the test set and the data provenance

Sample Size: The documents do not detail a specific "test set" in the context of a clinical performance study with human subjects, as would be common for AI/diagnostic devices. The evaluation focuses on material properties, biocompatibility, and comparison to a predicate device. If animal studies or limited human clinical data were part of the submission, their details are not included in this summary.
Data Provenance: Not applicable in the context of a "test set" for clinical performance as described. The manufacturing location is listed as Frankfurt, Germany.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no described "test set" requiring expert-established ground truth for performance evaluation in the way a diagnostic AI device would. The evaluation is based on material science, literature, and predicate device comparison.

4. Adjudication method for the test set

Not applicable. There is no described "test set" for clinical performance requiring adjudication.

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

No. This is a bone grafting material, not a diagnostic AI device. An MRMC study is not relevant to its clearance.

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

Not applicable. This is a physical medical device (bone grafting material), not an algorithm or AI.

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

The "ground truth" for this device's clearance is primarily based on:
- Scientific and engineering principles: Demonstrating that the material properties (composition, porosity, mechanical stability, resorption) are suitable for the intended use.
- Biocompatibility testing: Ensuring the material is safe to be implanted in the human body (though specific test results are not in this summary).
- Literature review and established clinical use: Reliance on the known safety and effectiveness of similar tricalcium phosphate-based bone grafting materials, particularly the predicate device.
- Regulatory precedent: A successful 510(k) clearance often relies heavily on demonstrating scientific and technological similarity to a device already cleared by the FDA.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning model that would have a "training set."

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

Not applicable. There is no "training set."

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, featuring a stylized caduceus symbol. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 6, 2024

Curasan AG C/O Roger Gray VP Quality And Regulatory Donawa Lifescience Consulting Srl Piazza Albania, 10 Rome, 00153 ITALY

Re: K103709

Trade/Device Name: Ceracell Dental® DENTAL Regulation Number: 21 CFR 872.3930 Regulation Name: Bone grafting material Regulatory Class: Class II Product Code: LYC

Dear Roger Gray:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 10, 2011. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under the product code LYC.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Andrew Steen, OHT : Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, 301-796-6284, or andrew.steen(a)fda.hhs.gov.

Sincerely,

Andrew I. Steen -S

Andrew I. 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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Curasan AG C/O Mr. Roger Gray VP Quality and Regulatory Donawa Lifescience Consulting Srl Piazza Albania, 10 00153 Rome ITALY

MAR 1 0 2011

Re: K103709

Trade/Device Name: Curasan Ceracell® DENTAL Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Codes: LPK and LYC Dated: December 17, 2010 Received: December 20, 2010

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 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,

Anthony D.m

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

Enclosure

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Appendix A

Indications for Use Statement

510(k) Number (if known): Not known (K103709

Device Name: Curasan Ceracell® DENTAL

Indications for Use: Ceracell® DENTAL is indicated for:

Augmentation or reconstructive treatment of the alveolar 0 ridge
Filling of infrabony periodontal defects .
Filling of defects after root resection, apicoectomy, and 0 cystectomv
Filing 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)
Filling of perio-implant defects in conjunction with � products intended for Guided Bone Regeneration (GBR)

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

ਕ

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

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

Concurrence of CDRH, Office of Device Eyaluation (ODE)

Susan Cuomo

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

510(k) Number: K033709

Page 1 of 1 Rev.2 Apr 4. 2008

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Appendix B

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

Device Name:	Ceracell® DENTAL
Type of 510(k) submission:	Abbreviated
Manufacturer:	Curasan AG,Frankfurt FacilityIn Der Schildwacht 1365933FrankfurtGermany
FDA Registration Number:	3004847139
510(k) Owner:	Curasan AGLindigstrasse 463801 KleinostheimGermany
	Phone: +49 (0)60 27 40 900 0Fax: +49 (0)60 27 40 900 29
FDA Registration Number:	3003771570
510(k) Submitter and Contact:	Mr Roger GrayVP Quality and RegulatoryDonawa Lifescience ConsultingPiazza Albania 1000153 RomeItalyPhone: +39 06 578 2665Fax: +30 06 574 3786Email: rgray@donawa.com
FDA Product Code:	LYC
FDA Regulation Number: FDA	872.3930
Classification Name:	Dental Bone Grafting Material
Common Name:	Tricalcium phosphate bone grafting material
FDA Panel:	Dental
FDA Classification:	Class II
FDA Identification:	Bone grafting material is a material such as hydroxyapatite,tricalcium phosphate, polylactic and polyglycolic acids, orcollagen, that is intended to fill, augment, or reconstructperiodontal or bony defects of the oral and maxillofacial region.
FDA Guidance Applied:	Class II Special Controls Guidance Document: Dental BoneGrafting Material Devices

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Indications for Use:

Ceracell® DENTAL is indicated for:

Augmentation or reconstructive treatment of the alveolar . ridge
. Filling of infrabony periodontal defects
. Filling of defects after root resection, apicoectomy, and cystectomy
. Filing 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)
Filling of perio-implant defects in conjunction with products . intended for Guided Bone Regeneration (GBR)

Technological and Performance Characteristics:

The material is doped with 4% sodium-magnesium-silicate to provide mechanical stability.

Ceracell® DENTAL morsels are available in a range of morsel sizes and quantities.

The final product is packed in glass vials, fitted with brombuty rubber stoppers, then subjected to a gamma radiation sterilization process before being packed in outer cartons.

Resorption time varies with technique from 4 to 12 months.

Comparison with predicate device:

The predicate device selected for companson with Ceracell® DENTAL is identified as follows:

Device:	Cerasorb® Dental
510(k) Sponsor:	Curasan AG
510(k) Number:	K051443
Clearance Date:	3 August 2005
FDA Product Code:	LPK
Classification Name:	Tricalcium phosphate granule for dental bone repair
Regulation No:	872.3930

The majority of the device characteristics for Ceracell® DENTAL are identical to those of the predicate device. Where they are not identical (device composition, volumetric porosity and phase purity), they are very similar, and these differences have no significant effect on device safety or effectiveness.

Conclusion:

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

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.