CERACELL DENTAL

{0}------------------------------------------------ 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 {1}------------------------------------------------ ## 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. {2}------------------------------------------------ ## 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 {3}------------------------------------------------ # 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 {4}------------------------------------------------ ; K103 769 # 16571 v ្ម 11. 讯 ્ત્રી .............................................................................................................................................................................. ﻨﺪ ﺒﻴﻨ # 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,<br>Frankfurt Facility<br>In Der Schildwacht 13<br>65933Frankfurt<br>Germany | | FDA Registration Number: | 3004847139 | | 510(k) Owner: | Curasan AG<br>Lindigstrasse 4<br>63801 Kleinostheim<br>Germany | | | Phone: +49 (0)60 27 40 900 0<br>Fax: +49 (0)60 27 40 900 29 | | FDA Registration Number: | 3003771570 | | 510(k) Submitter and Contact: | Mr Roger Gray<br>VP Quality and Regulatory<br>Donawa Lifescience Consulting<br>Piazza Albania 10<br>00153 Rome<br>Italy<br>Phone: +39 06 578 2665<br>Fax: +30 06 574 3786<br>Email: 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,<br>tricalcium phosphate, polylactic and polyglycolic acids, or<br>collagen, that is intended to fill, augment, or reconstruct<br>periodontal or bony defects of the oral and maxillofacial region. | | FDA Guidance Applied: | Class II Special Controls Guidance Document: Dental Bone<br>Grafting Material Devices | {5}------------------------------------------------ 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: 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. 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.