TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS

{0}------------------------------------------------ 034024 510 (k) submission for TESCERA Fiber Bundles, Fiber Mesh, and Fiber Cylinders BISCO INC., 1100 West Irving Park Road Schaumburg, IL 60193 MAR 1 9 2004 ## Section 5 Page 5-1 ## 510 (k) SUMMARY | 1. Applicant: | Bisco, Inc<br>1100 West Irving Park Road<br>Schaumburg, IL 60193 | |-----------------------|-----------------------------------------------------------------------------| | Contact Person: | Benjamin Lichtenwalner<br>Ph. 847-534-6146<br>Fax 847-534-6111 | | Prepared Date: | December 23, 2003 | | 2. Device Trade Name: | TESCERA Fiber Bundles, Fiber Mesh, and Fiber Cylinders | | Common/Usual Name: | Fiber Reinforcement material | | Classification/Name: | Class II per 21 CFR 872.3760 Denture Relining, Repairing, or Rebasing Resin | - 3. Predicate Device: Ribbond-Triaxial from Ribbond, Inc, cleared under K013881 dated 01/25/2002 ### 4. Description of Application Device: TESCERA Fiber Bundles, Fiber Mesh, and Fiber Cylinders are glass fiber reinforcement materials for composite and acrylic dental restorative materials. The TESCERA Fiber Bundles are loose fiber bundles. The TESCERA Fiber Mesh is a plain woven mesh. The TESCERA Fiber Cylinders are woven cylinders (sleeves) that come in several diameters. They are designed to be used with the TESCERA indirect composite system but should be effective with other indirect and direct systems #### 5. Intended Uses of Applicant Device: TESCERA Fiber Bundles, Fiber Mesh, and Fiber Cylinders are designed to be incorporated into devices as reinforcement in clinical situations where added strength is suggested or required. These situations include removable prosthetic devices such as dentures, splints, and orthodontic appliances as well as fixed prosthetic devices such as inlays, crowns, bridges, and splints. The intended uses of the applicant device are the same as the predicate device. | Technological<br>Characteristics | TESCERA Fiber Bundles, Fiber<br>Mesh, and Fiber Cylinders | Ribbond-Triaxial | |----------------------------------|--------------------------------------------------------------|------------------------------------| | Intended use | Reinforcing Material | Reinforcing Material | | Form | Fiber bundles, woven fiber mesh<br>and woven fiber cylinders | Woven fiber ribbon | | Physical/Mechanical | Increases the Flexural Strength of | Increases the Flexural Strength of | | Properties | dental materials | dental materials | #### 6. Technological Characteristics: Side by side comparisons of TESCERA Fiber Bundles, Fiber Mesh, and Fiber Cylinders to the predicate device Ribbond-Triaxial from Ribbond, Inc clearly demonstrates that the applicant devices are substantially equivalent to the legally marked devices. TESCERA Fiber Bundles, Fiber Mesh, and Fiber Cylinders were tested for biocompatibility and they were found to be non-toxic. It is concluded that the information supplied in this submission has proven the safety and efficacy of TESCERA Fiber Bundles, Fiber Mesh, and Fiber Cylinders. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or feathers. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 1 9 2004 Mr. Benjamin Lichtenwalner Regulatory Affairs Coordinator Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193 Re: K034024 Trade/Device Name: TESCERA Fiber Bundles, Mash, and Fiber Cylinder Regulation Number: 872.3760 Regulation Name: Denture Relining, Repairing or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: December 24, 2003 Received: January 7, 2004 Dear Lichtenwalner: 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. {2}------------------------------------------------ Page 2 - Ms. Rivkowich 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 (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), please contact the Office of Compliance at (301) 594-5618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Clus Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known): Ko 340 24 Device Name: TESCERA Fiber Bundles, Fiber Mesh, and Fiber Cylinders Indications For Use: As reinforcement for: - 1. Removable dentures - 2. Crown and bridge (Composite) - a. single units - b. multiple unit bridges - inlay bridges C. - Maryland Bridges ರ. - 3. Provisional Crown and Bridge - a. single units - b. inlay bridges - c. multiple unit bridges - d. Maryland Bridges - 4. Splint device reinforcement (Bruxism Appliance) - 5. Splinting of teeth - 6. Orthodontic Appliances Prescription Use ✓ (Part 21 CFR 801 Subpart D) 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) Susan Russo (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices AND/OR Page 1 of 1 510(k) Number:***_***_