PEAK Z

{0}------------------------------------------------ # Section 5 # Traditional 510(k) Summary This summary of the Traditional 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807 .92. #### Applicant's Name and Address Ultradent Products, Inc. 505 West 10200 South South Jordan, UT 84095 SEP 06 2013 Contact Person: Title: Telephone: FAX: Date Summary Prepared: Diane Rogers Manager of Regulatory and Global Affairs (800) 552-5512 x4491, (801) 553-4491 (801) 553-4609 May 10, 2013 #### Name of the Device | Trade Name: | Peak® Z | |------------------------------|---------------------------| | Common Name: | Resin tooth bonding agent | | Device Classification: | Class II | | Classification Product Code: | KLE | #### Legally Marketed Predicate Devices to Which Equivalence is Claimed The predicate device is: K091705 Prime Plus (Z Prime Plus) by Bisco Inc. located at 1100 W. Irving Park Road, Schaumburg IL 60193. Peak® Z is very similar to our predicate device in that both devices are intended to be used as resin tooth bonding agents. Indications for Use: Peak® Z is intended for use as a surface treatment for restorations made of the following materials: - Zirconia . - Aluminum oxide � - Metal/Alloy . - Titanium � {1}------------------------------------------------ Product Description: Peak® Z is a single component surface treatment that enhances bond values when applied to zirconia, alumina, and metal/alloys. It contains 12methacryloyIdoeceylphosphate (MDP), which produces a chemical bond that significantly increases adhesion between a resin-based material and the bonding surface of the restoration. Peak® Zr Primer can be applied through a syringe delivery or brush and bottle. ## Technological characteristics | Product | 510(k) Number | Indications for Use | |------------------------|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Peak® Z | | Peak® Z is intended for use as a surface treatment for restorations made of the following materials:<br>Zirconia Aluminum oxide Metal/Alloy Titanium | | Primer plus ( Z-Prime) | K091705 | The principal uses of the Primer Plus are:<br>1. Indirect restorations (such as composite, endodontic posts, metal/metal alloys, porcelain, zirconia, alumina, ceramics, and hybrid ceramics)<br>2. Intraoral repairs of fractured crowns and bridges (such as metals/metal alloys, porcelain, zirconia, alumina, ceramics, or composite resin). | | Characteristics | Surface treatment to enhance<br>restorations and repairs | Surface treatment to enhance<br>restorations and repairs | | Human Factors | Syringe delivery or brush and<br>bottle | Brush and bottle | {2}------------------------------------------------ | Biocompatibility | ISO 10993 | ISO 10993 | |------------------|---------------|---------------| | | Cytotoxicity | Cytotoxicity | | | Sensitization | Sensitization | | | Irritation | Irritation | | | Genotoxicity | Genotoxicity | Peak® Z is supplied in a pre-mixed syringe for easy delivery and no waste, and also in bottles with brushes that can be directly applied to surfaces. Primer plus is supplied in single bottles that can be directly applied to surfaces. The patient population is intended for all ages that need a restoration or repair as prescribed by a dentist. The device is a primer that is intended to prepare surface treatments of restorations and repairs. ### Brief Description of Testing Performed The following bench tests were conducted during the R & D phase on Peak ® Z and compared to K091705 Primer Plus) by Bisco Inc. Final test results are in Section 18 "Bench Testing". Shear bond: This in-vitro test determines how well the material enhances the bonding to various surfaces compared to both the Bisco's system and the Ultradent system without a primer. This shows whether or not a primer is needed and if the R&D formulation, Peak® Z, (PAZR41) is comparable to a product that is currently on the market and is well-received. Shear bond with artificial aging and conditions: This in-vitro test artificially replicates a possible extreme condition that may occur in the clinical setting. This will indicate whether or not the material is robust enough compared to a product currently on the market. Stability: The material was tested at various data points to verify that the function of the product did not degrade under normal and accelerated conditions. ### Clinical Summary A complete Clinical Summary of Peak® Z is included in Section 20: We conducted a literature study to show safety and effectiveness of this product can be used on any age patient when treatment is prescribed by a dentist. The device has the same technological characteristics compared to K091705 Primer Plus (Z Prime Plus) by Bisco inc. Primer Plus has been widely used by numerous dentists in the dental industry. {3}------------------------------------------------ The efficacy or suitability to the intended purpose of Peak® Z has been demonstrated by a combination of in-house testing and side-by-side comparisons to a predicate device currently on the market. Results of our bench testing indicates that Peak® Z performs as well or better than the predicate device currently on the market. ### Summary Risk/Benefit Review Considering the safe history of our predicate, K091705 Primer Plus (Z Prime Plus) by Bisco Inc., Peak® Z is substantially equivalent and considered to be a safe medical device. Our research indicates that our predicate has been used by many dentists and large group practices in the United States and purchased by a large number of international distributors. To date, there have been no reported complaints of local or systemic adverse effects associated with the use of the predicate product. Peak® Z was tested for biocompatibility in Cytotoxicity, Sensitization and Genotoxicity tests according to ISO 10993-1. An abstract of the testing along with signed test reports are included in Section 15 "Biocompatibility" of this submission. In conclusion, Peak® Z has been designed and manufactured with the intended use and claims for the product in mind. Scientific literature, etc. has been collected and evaluated to determine safety and efficacy of similar products used for the same indication. Following the clinical review as documented above, Ultradent Products, Inc. deems that when this device is used under the conditions and for the purposes intended, it will not compromise the clinical condition or the safety of the patient and the association with its use constitutes acceptable risks when weighed against to the patient. Therefore, the product is compatible with a high level of protection of health and safety and may be released to the market. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002 #### September 6, 2013 Ultradent Products, Incorporated Ms. Diane Rogers Manager of Regulatory and Globel Affairs 505 West 10200 South SOUTH JORDAN UT 84095 Re: K131357 Trade/Device Name: PEAK® Z Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: June 6, 2013 Received: June 10, 2013 Dear Ms. Rogers: 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. {5}------------------------------------------------ #### Page 2 - Ms. Rogers 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm. Sincerely yours. Image /page/5/Picture/7 description: The image shows the name "Mary S. Runner - S" in a bold, sans-serif font. The text is horizontally oriented and appears to be a signature or label. The letters are clearly legible, with consistent spacing between the words and initials. Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## Statement of Indications for Use K131357 510(k) Number (if known): __ Device Name: Peak® Z Indications for Use: Peak® Z is intended for use as a surface treatment for restorations made of the following materials: - Zirconia . - Aluminum oxide . - Metal/Alloy � - . Titanium Prescription Use _ X (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 OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page _1_ of _1_ # Andrew I. Steen -S 2013.09.06 09:32:53 -04'00' . ' (Posted November 13, 2003) (Division Sign-Off) Tivision of Anesthesiology, General Hospital ifection Control, Dental Devices 10(k) Number: K13357