CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO

{0}------------------------------------------------ K113282 # 510(k) Summary Section 05 Erst Arzneimittel AG # Special 510 (k) Summary: CERASORB® CLASSIC CERASORB® M CERASORB® Perio SEP 2 0 2012 Date prepared: September 17, 2012 ### l. SUBMISSION INFORMATION | Name and Address<br>of the Sponsor: | Riemser Arzneimittel AG<br>An der Wick 7<br>Greifswald-Insel Riems<br>Mecklenburg-Vorpommern 17493, Germany | |-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact person: | Dr. Andreas Püttner<br>Head of Regulatory Affairs<br>Tel.: +49-3835-1760<br>Fax: +49-3835-176778<br>E - Mail: dr.puettner@riemser.de | | Registered U. S. Agent: | James M. Clinton<br>Quality & Regulatory Consulting, LLC<br>5105 Fairoaks Rd<br>Durham, NC 27712, USA<br>Phone: +1919-247-0479, fax: +1919-287-2551<br>E - Mail: clintonjm@earthlink.net | | 2. DEVICE IDENTIFICATION | | | Proprietary Name: | CERASORB® CLASSIC<br>CERASORB® M<br>CERASORB® Perio | | Common Name: | Bone Void Filler, Synthetic | | Classification Name: | Bone Grafting Material, Synthetic | Classification: Class II, Special Controls Classification regulation Number: 21CFR 872.3930 - . Product Code: LYC {1}------------------------------------------------ # 510(k) Summary ### Section 05 #### 3. PREDICATE DEVICES CERASORB® DENTAL: k051443 CERASORB® M DENTAL: k051443 CERASORB® Perio: k051443 #### 4. INTENDED USE CERASORB® CLASSIC and CERASORB® M are recommended for: -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) -Filling of perio-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR) ### CERASORB® Perio is recommended for: -Filling and/or reconstruction of non-infected periodontal bone defects in conjunction with other products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) -Filling of infrabony periodontal defects - -Filling of single-or multi-wall bone pockets -Filling of bifurcations and trifurcations #### DESCRIPTION OF THE DEVICE 5. CERASORB® CLASSIC, CERASORB® M and CERASORB® Perio are a sterile, synthetic, porous and biocompatible ceramic matrix in either granular form (CERASORB® CLASSIC), polygonal shaped morsels (CERASORB® M) or polygonal broken granulate (CERASORB® Perio). All designs consist of pure-phase Beta-Tricalcium Phosphate with a phase purity of ≥ 99% and comply with the ASTM F 1088-04. The devices, when applied to a bony defect, create a network of large, smoothly interconnected pores providing different porosities (CERASORB® CLASSIC approx, 35%, CERASORB® M approx. 65 vol% [total porosity] and CERASORB® Perio approx. 25vol%). The different designs are manufactured by a validated manufacturing process which guarantees batch to batch conformity and reproducibility. In contact with vital bone the CERASORB® granules, morsels or granulate is resorbed and gradually replaced by new bone. {2}------------------------------------------------ | <b>CERASORB ^® </b> | Section 05 | |---------------------------------|-------------------------------------------------------| | 510(k) Summary | <div> RIEMSER </div> <div> Arzneimittel AG </div> | CERASORB® CLASSIC, CERASORB® M and CERASORB® Perio are provided in double sterile packages (sterilization via gamma irradiation) and are for single-use only. #### BASIS FOR SUBSTANTIAL EQUIVALENCE 6. CERASORB® CLASSIC, CERASORB® M and CERASORB® Perio differ from the products of the same name cleared by k051443 only in the information on the labeling designating the manufacturer. Riemser AG is now both the manufacturer and distributor of the CERASORB® products described in the present 510(k) document. ### STATEMENT OF TECHNOLOGICAL COMPARISON 7. The CERASORB® CLASSIC, CERASORB® M, and CERASORB® Perio devices are substantially equivalent to the respective devices cleared by k051443: CERASORB® DENTAL, CERASORB® M Dental, and CERASORB® Perio. 5 - 3 {3}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name encircling a stylized eagle emblem. The eagle is depicted with three overlapping, curved lines forming its body and wings, conveying a sense of motion and progress. The overall design is simple, yet recognizable, representing the department's role in public health and human services. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 SEP 2 0 2012 Riemser Arzneimittel AG C/O Mr. James M. Clinton Quality & Regulatory Consulting, Limited Liability Company 5105 Fairoaks Road Durham, North Carolina 27712 Re: K113282 Trade/Device Name: Cerasorb® Classic Cerasorb® M Cerasorb® Perio Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: August 17, 2012 Received: August 21, 2012 Dear Mr. Clinton: 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. {4}------------------------------------------------ ### Page 2- Mr. Clinton 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/ResourcesforYou/Industry/default.htm. Sincerely yours. Nh 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 {5}------------------------------------------------ # Indications for Use Page 1 of l Page 1 of *_*_ Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Kummer (Division Sign-Off) (Division Sign-Off) Division of Anesthesiology, General Hospital Division of Anesthesion Devices Division of Anest. Dental Devices 510(k) Number: K113252 4 - 1 # Indications for Use KI13282 510(k) Number (if known): Cerasorb® CLASSIC Device Name: Indications for Use: Cerasorb® CLASSIC is recommended for: - Augmentation or reconstructive treatment of the alveolar ridge. - - ー 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). - Filling of perio-implant defects in conjunction with products intended for Guided -Bone Regeneration (GBR). Prescription Use (Part 21 CFR 801 Subpart D) IF NEEDED) AND/OR (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE Over-The-Counter Use (21 CFR 807 Subpart C) Section 04 (k) Number (if known): K 1 328 Cerasorb® CLASSIC {6}------------------------------------------------ | CERASORB® | |-----------| |-----------| ### Indications for Use Indications for Use 510(k) Number (if known): Cerasorb® M Device Name: Indications for Use: Cerasorb® M is recommended for: - 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). - Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR). Prescription Use (Part 21 CFR 801 Subpart D) :: '' ' AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) Section 04 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | | Page 1 of | |----------------------------------------------|-----------| | (Division Sign-Off) | | | Division of Anesthesiology, General Hospital | | | Infection Control, Dental Devices | | | 510(k) Number: | K113282 | 4 - 2 {7}------------------------------------------------ # Indications for Use Image /page/7/Picture/2 description: The image shows the text "K113282" at the top, followed by "Section 04" in bold. The text "Section 04" is centered and has a line above it. Below that is a logo that is difficult to make out. A. 2022年12月16日 ### Indications for Use 510(k) Number (if known): Cerasorb® Perio Device Name: Indications for Use: Cerasorb® Perio is recommended for: - Filling and/or reconstruction of non-infected periodontal bone defects in conjunction with other products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR). - Filling of infrabony periodontal defects - Filling of single-or multi-wall bone pockets. - Filling of bifurcations and trifurcations Prescription Use > (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 of CDRH, Office of Device Evaluation (ODE) Division Sian-Off) Division of Anesthesiology, General Hosanal Infection Control, Dental Devices Page 1 of 510(k) Number: K152858 4 - 3