PROCERA ALLCERAM BRIDGE MATERIAL

{0}------------------------------------------------ K020269 MAR 2 7 2002 #### VII. 510(k) SUMMARY ## Manufacturer Information: | Submitters Name: | Procera Sandvik AB | |------------------|-----------------------------------------------------------------------------------| | Address: | Lerkrogsvägen 19<br>126 80 Stockholm<br>Sweden | | Contacts name: | Agneta Odén, MSc, Ph.D., DDS<br>Director Quality Assurance and Regulatory Affairs | | Telephone Number | +46 8 726 66 19 | | Data Prepared: | January 2001 | Device Names: | Comman Name: | Glass reinforced with Aluminium Oxide Particles | |--------------|-------------------------------------------------| | Trade Name: | Procera® AllCeram Bridge Material | ## Predicate Device: Substantial equivalence is claimed to Nobel Biocare AB' Procera® AllCeram Fusing Material (K983453). ## Device Description: Procera® All Ceram Bridge Material is composed of Procera® AllCeram Connection Material (a premixed suspension of aluminium oxide particles, dispersant of the particles, binder for the particles and de-ionized water) and Procera® AllCeram Fusing Material (a suspension of glass material and water). Procera 8All Ceram Bridge Material is used to fuse together sections of core material in densely sintered aluminium oxide of a dental all ceramic bridge. #### Intended Use: Procera Sandvik's Procera 9 All Ceram Bridge Material is intended to be used to fuse together the sections of an aluminium oxide framework for a dental bridge. ## Comparison to Predicate: The following table (Table 7.1 and Table 7.2) provides a comparison of the technological characteristic of the candiate Procera Sandvik's Procera "All Ceram Bridge Material to the predicate Nobel Biocare's Procera "All Ceram Fusing Material {1}------------------------------------------------ # 510(k) Summary (continued) 1 . ## Table 7.1. Similarities to the predicate | Table 7.1. Similarities to the predicate | | | |------------------------------------------|-------------------------------------------------------------|-------------------| | Procera®All Ceram Bridge<br>Material | Aspect/Characteristic | Comment | | | Intended use | Same as predicate | | | Fusing temperature | Same as predicate | | | Chemical composition of<br>sintered joint glass<br>material | Same as predicate | ## Table 7.2. Differences from the predicate | Procera ®All Ceram Bridge | Aspect/Characteristic | Comment | |---------------------------|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | Material | | | | | Sintered structure of joint<br>material | Candidate is reinforced<br>with aluminium oxide<br>particles. | | | | Predicate is not | | | Fracture resistance | Candidate has between 24<br>to 47% increased strength<br>compared to predicate | | | Chemical composition of<br>sintered joint material | The glass phase has the<br>same chemical<br>composition as predicate.<br>The candidate contains<br>aluminium oxide particles<br>the predicate does not. | · {2}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized wings. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # MAR 2 7 2002 Dr. Agneta Oden Director, Quality Assurance and Regulatory Affairs Procera Sandvik AB Lerkrogsvagen 19, Vastberga 12680 Stockholm, SWEDEN Re: K020269 Trade/Device Name: Procera® AllCeram Bridge Material Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: January 24, 2002 Received: January 28, 2002 Dear Dr. Oden: 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 - Dr. Oden Please be advised that FDA's issuance of a substantial equivalence determination does not mean r loase be advisouration 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); an the Act I FFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Patricio Cincotti/for Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use Statement K020269 not yet assigned 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Procera® AllCeram Bridge Material _______________________________________________________________________________________________________________________________ Indications For Use: Procera® AllCeram Bridge Material is composed of Procera® AllCeram Connection Material (a premixed suspension of aluminium oxide I rooff - Tiroerant of the particles, binder of the particles and deionised water) and Procera® AllCeram Fusing Material (a suspension of glass material and water) Procera® AllCeram Bridge Material is used to fuse together the sections of the core material in densely sintered aluminium oxide of a dental bridge. # (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) # Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use 1 OR Over-the-Counter Use (Optional Format 1-2-96) (Per 21 CFR 801.109) Surar Vunny "Twisian Sign-Off) Division of Dental, Infection Control, and General Hospital Devices Kasasta E10(k) Number ________________________________________________________________________________________________________________________________________________________________ Page 2.1