← Product Code [EMA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA) · K081405 # XERACEM (K081405) _Doxa Dental AB · EMA · Aug 21, 2008 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K081405 ## Device Facts - **Applicant:** Doxa Dental AB - **Product Code:** [EMA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA.md) - **Decision Date:** Aug 21, 2008 - **Decision:** SESE - **Submission Type:** Abbreviated - **Regulation:** 21 CFR 872.3275 - **Device Class:** Class 2 - **Review Panel:** Dental ## Indications for Use XeraCem is a hybrid between glass ionomer cement and ceramic cement based on calcium aluminate. It combines the advantages of glass ionomer cements with those of calcium aluminum based cements. XeraCem is a hand mixed cement and consists of a powder (XeraCem powder) and a liquid (XeraCem liquid). XeraCem is intended for the permanent cementiation of - Porcelain Fused to Metal Crowns and Bridges . - Metal (gold etc.) crowns and bridges . - Gold inlays and onlays . - . Prefabricated metal and cast posts - . Prefabricated metal provisional crowns - . All-zirconia or all-alumina ceramic crowns and bridges ## Device Story XeraCem is a hybrid glass ionomer-ceramic dental cement based on calcium aluminate; supplied as powder and liquid components. Clinician performs manual mixing of components prior to application. Used by dentists for permanent cementation of various dental restorations including crowns, bridges, inlays, onlays, and posts. Provides mechanical fixation of dental prosthetics to tooth structure. Benefits include combining properties of glass ionomer and calcium aluminate cements for dental restoration stability. ## Clinical Evidence Bench testing only. Physical and mechanical studies compared XeraCem to predicate devices. Biocompatibility testing included cytotoxicity, genotoxicity, irritation, and sensitization. All performance observed was as expected. ## Technological Characteristics Hybrid glass ionomer-ceramic dental cement; calcium aluminate-based; hand-mixed powder and liquid components. No specific ASTM standards cited. No software or electronic components. ## Regulatory Identification Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. ## Predicate Devices - KetacTM Cem Maxicap ([K897188](/device/K897188.md)) - DoxaDentTM ([K011839](/device/K011839.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## 5. 510(k) Summary, XeraCem™ ## 5.1. Submitter Jonathan S. Kahan, Esg. Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, D.C., 20004 Phone: (202) 637 5794 Facsimile: (202)637 5910 AUG 2 1 2008 Date Prepared: May 19, 2008 #### 5.2. Device Name and Name/Address: of Sponsor XeraCem™ Doxa Dental AB Axel Johanssons gata 4-6, SE 754 51 Uppsala, Sweden #### Common or Usual Name Dental Cement #### Classification name Dental cement other than zinc oxide-eurgenol (21 CRF 872.3275) #### Product Code EMA #### 5.3. Predicate Devices | Trade name | 510(k) holder | 510(k) No. | |---------------------|----------------|------------| | KetacTM Cem Maxicap | ESPE GMBH | K897188 | | DoxaDentTM | Doxa Certex AB | K011839 | ## 5.4. Intended Use/Indications for Use XeraCem is a hybrid between glass ionomer cement and ceramic cement based on calcium aluminate. It combines the advantages of glass ionomer cements with those of calcium aluminum based cements. XeraCem is a hand mixed cement and consists of a powder (XeraCem powder) and a liquid (XeraCem liquid). XeraCem is intended for the permanent cementiation of - Porcelain Fused to Metal Crowns and Bridges . - Metal (gold etc.) crowns and bridges . - Gold inlays and onlays . - . Prefabricated metal and cast posts {1}------------------------------------------------ - . Prefabricated metal provisional crowns - . All-zirconia or all-alumina ceramic crowns and bridges ## 5.5. Technological characteristics XeraCem is a hybrid glass ionomer-ceramic dental cement, reconstituted prior to use by hand mixing the XeraCem powder with the XeraCern liguid. ### 5.5. Performance Data XeraCem is technologically identical to the previously cleared Ketac Cem Maxicap. Various physical and mechanical studies were conducted to compare XeraCem the predical realidas XeraCem has been evaluated and passed biocompatibility testing of cytotoxicity, genotoxicity, irritation, and sensitization. In all instances, XeraCem functioned as intended and the performance observed was as expected. ## 5.6. Substantial Equivalence XeraCem is as safe and effective as the predicate devices. XeraCem has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. Thus, XeraCem is substantially equivalent. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with three curved lines representing its wings or feathers. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Doxa Dental AB C/o Mr. Jonathan Kahan Regulatory Counsel Hogan & Hartson LLP 555 Thirteenth Street, NW Columbia Square Washington, DC 20004 AUG 2 1 2008 Re: K081405 Trade/Device Name: XeraCem™ Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: August 18, 2008 Received: August 18, 2008 Dear Mr. Kahan: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. {3}------------------------------------------------ #### Page 2 - Mr. Kahan 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours. Chiu S. Lin, Ph.D. Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # 4. Indications for Use, XeraCem™ 510(k) Number (if known): 5081405 Device Name: XeraCem™ Indications for Use: XeraCem is intended for the permanent cementation α= - Porcelain Fused to Metal Crowns and Bridges . - Metal (gold etc.) crowns and bridges ● - Gold inlays and onlays . - Prefabricated metal and cast posts - Prefabricated metal provisional crowns - All-zirconia or all-alumina ceramic crowns and bridges Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Ower-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) Susan Graves (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K081005 Fage 1 of 1 4. Indications for Use, XeraCem Page 4-1 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K081405](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K081405) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com