BIOSPLINT SPLINTING RIBBON

{0}------------------------------------------------ Ko 53328 # Section III - SMDA Summary of Safety and effectiveness – "510(K) Summary" ## 1. Submitter Information: Produits Dentaires Pierre Rolland ZI du Phare, 17 avenue Gustave Eiffel Mérignac Cedex 33708 France Telephone: 011 33 556 34 0607 Fax: 011 33 556 34 9292 Contact person: Steven SALESKY SATELEC c/o Acteon, Inc. 130 Gaither Drive, Suite 100 Mt. Laurel, NJ 08054 Telephone: 856 222-9988 Fax: 856 222-4726 Date summary prepared: November 25th , 2005 ### 2. Device name | Trade Name: | BIOSPLINT Splinting ribbon | |----------------------|------------------------------------------------------------------------------| | Common/Usual Name: | Dental Splinting ribbon | | Classification Name: | Dental / Resin, denture, Relining, Repairing, Rebasing, per 21 CFR §872.3760 | # 3. Devices for which Substantial Equivalence is claimed: - RIBBOND (RIBBOND Inc) K913040 dated 10/07/1991 .. - CONNECT (SYBRON DENTAL SPECIALITIES Inc) K954689 dated 10/30/1995 - 1 {1}------------------------------------------------ ## 4. Device description: ### PRESENTATION Box containing: - 8 ribbons (Braided polyethylene terephtalate fibers) individually wrapped in aluminium bags (width: approximately 2.5 mm - length: approximately 50 mm - thickness: ~ 0,15 mm). - Accessories: BIOSPLINT™ Thermal cutter, BIOSPLINT™ Accessories: brushes and probes - ### PROPERTIES BIOSPLINT™ Splinting ribbons are fixed to the teeth using a light curing flowable hybrid composite and a one-bottle light-curing adhesive system. BIOSPLINT™ Splinting ribbons are treated using the so-called "super-critical fluid" process. This treatment is a process for "cleaning" the fibers, allowing to improve the impregnation of the fiber by the composite and thus to improve the cohesion of the overall tooth retention system BIOSPLINT™ Splinting ribbons can be pliable in order to the curves of the teeth. Their low thickness makes it possible to avoid any oral embarrassment after setting in place. BIOSPLINT™ Splinting ribbons can remain in place for several years if necessary; in this case a regular monitoring of the patient is necessary. #### Intended use of the Device 5. BIOSPLINT™ Splinting ribbons are used for Stabilization of mobile teeth, Temporary replacement of missing teeth, Maintain of inter-dental spaces, Reinforcement or repairing of temporary or permanent bridges. ### 6. Substantial Equivalence: The BIOSPLINT™ Splinting ribbon is substantially equivalent to other legally marketed devices in the United States: CONNECT and RIBBOND are intended for a similar use. {2}------------------------------------------------ #### Efficacy of the Device 7. The efficacy of the use of this kind of device is well established in the professional literature since 1992 (GOLDBERG AJ, BURSTONE CJ, "The use of continuous fiber reinforcement in dentistry" dent.mater 1992; 8:197-202). The BIOSPLINT™ Splinting ribbon has been successfully used in Europe since 1997. The following articles concerning their efficacy in clinical practice have been published in French professional literature: - «Provisional mandibular contention, : interest of BIOSPLINT - About a clinical case» N.KOUBI and G. ABOUDHARAM - G.KOUBI Chairman of university Marseilles France Information dentaire n° 1 du 5 janvier 2000 p 11-19 - «Uses of fibers reinforced composite in dentistry » BIJAOUI J. - SIMON A.L. - TIRLET G. René DESCARTES University PARIS 5 -France Les cahiers de l'ADF N° 10 - 4ème trimestre 2000 - « A new material for an esthetic contention : polyethylenephtalate fibers » OUHAYOUN J.P. and BENALIKHOUJA M. University of Garancière PARIS 7 -France Information dentaire n° 9 du 28 février 2001 p 569-578 · «Temporary replacement of unit tooth in implantology: polymere ribbon and flowable composite» OUHAYOUN J.P. University of Garancière PARIS 7 -France Alternatives n° 26 de mai 2005 p 45-49 The mechanical and esthetic properties of these kinds of fibers enhance the use of these products in the recommended clinical situations. Copies of listed articles are available upon request. {3}------------------------------------------------ #### Safety of the Device 8. The BIOSPLINT™ Splinting ribbon is controlled according to the specifications presented in Appendix D. BIOSPLINT™ Splinting ribbon comply to the following tests: ### AMES test, Method: according to guidelines O.C.D.E.n°471 (1981) - EEC 84/449 - annex V - method B14 (1984) ref: studv n° 104E201E Results and conclusion: According to the experimental conditions described, the flat fibers ref FTEKRU1950 has no mutagenic effect against TA-98, TA-1535, TA-1537 and TA-1538 strains without metabolic activation. #### Pyrogenes test, Method: according to the French Pharmacopoeia - ref: study n ° 104E201A Results and conclusion: comply #### Sensitization test on guinea pigs । Method: according the method described in the Annual book of ASTM standards F 619-79- ref: study nº 104E201D Results and conclusion: According to the experimental conditions described (extract prepared at 37 °C during 120 hours with 0.9 % sodium chloride solutions), the fibers are not sensitizing. #### Intramuscular implantation on the rabbit, । Method: according to USP XXII - ref: study n° 104E102 Results and conclusion: comply #### Toxicity by systemic injection on the mouse - Method: according to USP XXII on extracts prepared at 50°C during 72 hours with 0.9 % sodium chloride solutions, 5 % alcohol solutions, gingili oil and polyethylene glycol 400 solutions. - ref: study n° 104E102 Results and conclusion: comply ### Intradermal injection on the rabbit Method: according to USP XXII on extracts prepared at 50°C during 72 hours with 0.9 % sodium chloride solutions, 5 % alcohol solutions, gingili oil and polyethylene glycol 400 solutions. - ref: study n° 104E102 Results and conclusion: comply ### Biocompatibility evaluation Method: implantation test on the rabbit (adaptation of ASTM F 763-87, F 981-87 and ISO 10993-6) was performed with a semi-quantitative histological study of the tissue response after 1, 4, 12, 26 and 52 weeks - ref: study n° 104E203 Results and conclusion: the macroscopical and histopathological observations did not show any local adverse effect which can be due to the fiber. #### in-vitro Cvtotoxicity । Method: according to USP XXIII - elution test (incubation 48 hours, 37 °C, 5% CO2) Results and conclusion: not cytotoxic Test results available upon request. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 2 5 2006 SATELEC C/O Mr. Steven Salesky Regulatory Affairs Acteon, Incorporated 130 Gaither Drive, Suite 100 Mount Laurel, New Jersey 08054 Re: K053328 Trade/Device Name: BIOSPLINT Splinting Ribbons Regulation Number: 872.3760 Regulation Name: Denture Relining Repairing or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: November 29, 2005 Received: December 1, 2005 Dear Mr. Salesky: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because of the device is substantially equivalent (for the relerenced above and have atternslosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mensiale commerce proces that have been reclassified in accordance with the provisions of Amendinents, or to de result Act (Act) that do not require approval of a premarket the Federal F ood, Drag, and Sobu may, therefore, market the device, subject to the general approvin approvisions of the Act. The general controls provisions of the Act include controls proviblems of an 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 (1 Mr.), it may be subject is the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device to rearly routher announcements concerning your device in the Ecderal Register. {5}------------------------------------------------ # Page 2 - Mr. Salesky Please be advised that FDA's issuance of a substantial equivalence determination does not r rease be advisod that I Dri-5 tooming on that your device complies with other requirements moan that I Dri nas made statutes and regulations administered by other Federal agencies. of the Act of any I edetal back's requirements, including, but not limited to: registration 1 ou must comply with art 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 OF R Part 877), abality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quadion 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) I mis feter whilance . Jourse of substantial equivalence of your device to a premarket notified.com. - The PDF 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), n you deather the Office of Compliance at (240) 276-0115. 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 may obtain other generational 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/industry/support/index.html. Sincerely yours, Clare 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 {6}------------------------------------------------ # Indication for Use 510(k) Number (if known): K053328 Device Name: BIOSPLINT Splinting ribbons Indications For Use: Stabilization of mobile teeth Temporary replacement of missing teeth Maintain of inter-dental spaces Maintain of microachar of temporary or permanent bridges Please refer to the attached file for a complete description. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR 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 Evaluation (ODE) Susan Russey Division (Area 09) Division of Respiratory, General Hospital, Infection Control, Dental Devices 1000 | Number Page 1 of 2