Life Fast Set, Life Regular Set

{0}------------------------------------------------ Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, suggesting a sense of community and care. The logo is presented in black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 19, 2015 Sybron Dental Specialties Ms. Kerri Casino Regulatory Affairs Manager 1717 W. Collins Avenue Orange, California, 92867 Re: K150559 Trade/Device Name: Life Regular Set and Life Fast Set Regulation Number: 21 CFR 872.3250 Regulation Name: Calcium hydroxide cavity liner Regulatory Class: II Product Code: EJK Dated: March 4, 2015 Received: March 6, 2015 Dear Ms. Kerri Casino: 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. 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 {1}------------------------------------------------ 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 Industry and Consumer Education 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. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely vours. # Erin I. Keith -S Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K150559 Device Name Life Fast Set/ Life Regular Set Indications for Use (Describe) Life Fast Set/ Life Regular Set is a hard-setting Calcium Hydroxide cavity liner and pulp capping agent to be used in conjunction with all permanent restorative techniques. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # SECTION 6. 510(k) SUMMARY FOR LIFE REGULAR SET/LIFE FAST SET Image /page/3/Picture/1 description: The image contains the logo for Sybron Dental Specialties. The logo features the letters "sds" in a stylized, bold, blue font. Below the letters, the words "Sybron Dental Specialties" are written in a smaller, sans-serif font, also in blue. A curved line appears above the letters, adding a design element to the logo. # Life Regular Set/Life Fast Set - 1. Submitter Information: Sybron Dental Specialties 1717 W. Collins Ave. Orange CA, 92687 | Contact Person: | Kerri Casino | |-------------------|--------------| | Telephone Number: | 714-516-7634 | | Fax Number: | 714-516-7472 | Date Prepared: March 4, 2015 #### 2. Device Name: ● - Proprietary Name: Life Regular Set and Life Fast Set . II - Classification Name: Liner, Cavity, Calcium Hydroxide - 872.3250 . CFR Number: - Device Class: ● - Product Code: EJK . #### 3. Predicate Device: Proposed Life Regular Set/Life Fast Set is substantially equivalent to the legally marketed device Life 2 (K012717) cleared on October 25, 2001, product code EJK. #### 4. Description of Device: Life Regular Set/Life Fast Set are hard setting Calcium Hydroxide cavity liners and pulp capping agents to be used in conjunction with all permanent restorative techniques. Life is a two-part, base/catalyst- paste/paste system. The two-part system is packaged in tubes. The product is available in two viscosities, Fast Set and Regular Set. - న. Statement of Intended Use: Life Regular Set/Life Fast Set is a hard-setting Calcium Hydroxide cavity liners and pulp capping agents to be used in conjunction with all permanent restorative techniques. {4}------------------------------------------------ - 6. Summary of Technological Characteristics: The base formulation of Proposed Life Regular Set and Life Fast Set and the predicate device, Life 2 (K012717), remains unchanged. The catalyst formulation of Proposed Life Regular Set and Life Fast Set and the predicate device, Life 2 (K012717), is very similar, the only difference being the Fumed Silica. The predicate Life 2 (K012717) contains 2-5% Fumed Silica Aerosil R972, CAS# 68611-44-9. The Proposed Life Regular Set and Life Fast Set contain 2-5% Fumed Silica Cab-o-sil TS720, CAS#67762-90-7. The mixing of the base and catalyst causes the mixture to harden. This is due to a chelation reaction between the calcium hydroxide and the salicylate moieties. The hardening of the thin layer occurs quickly so that the remaining steps of the procedure can proceed. The intention of a cavity base or pulp liner is to protect the pulp from thermal shock. The fumed silica is added to serve as a filler and rheological modifier. It does not participate in the reaction. The surface treatment of the fumed silica is conducted to make the filler more hydrophobic and to improve the compatibility with the formulation. The difference between a dimethyldichlorosilane treated fumed silica and a polydimethylsiloxane treated fumed silica is insignificant in this formulation. The formulation utilizing the alternative fumed silica has been on the market for a number of years internationally. Based on post market data, the performance characteristics of this material result in equivalent feedback as that of the predicate. The slight variation in fumed silica does not change the performance characteristics of the device. The primary tube packaging will be changed from a laminate plastic tube to a polyfoil tube, the same tube in which the international version of the product is currently sold and has been on the market for a number of years. The tube filling operation was validated per an internal process validation. Based on the number of years of successful clinical use of polyfoil tubing internationally and successful validation data, the Proposed Life Regular Set/ Life Fast Set tubing change is deemed substantially equivalent to the predicate Life 2 (K012717). - 7. Summary of Non-Clinical Performance Data: Verification and validation activities were performed in accordance with design control requirements as specified in 21 CFR 820.30 and ISO 13485:2012 Medical Devices-Quality Management Systems, and the results demonstrated substantial equivalence to the predicate. Risk analysis for the changes in manufacturing, packaging and formulation was performed utilizing ISO 14971:2012, Application of risk management to medical devices. No new hazards were identified based on post market data from the internationally sold product that has been on the market for a number of years utilizing the proposed manufacturing process, packaging and formulation. The filling process was validated per an internal process validation. #### 8. Substantial Equivalence: Life 2 (K012717) is an existing device which was granted market clearance by FDA in 2001. Sybron Dental Specialties seeks only to slightly modify the existing device cleared under K012717. Additionally, the device would be produced at a facility in Scafati, Italy. {5}------------------------------------------------ The table below depicts the modification associated with Life Regular Set and Life Fast Set. | Element | Predicate Device- Life 2<br>(K012717) | Proposed Life Regular Set/Life<br>Fast Set | |----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | Life 2 | Life Regular Set and Life Fast Set | | Target Users | Licensed dental professionals | Licensed dental professionals | | Device<br>Description | Life 2 is a hard setting Calcium<br>Hydroxide cavity liners and<br>pulp capping agents to be used<br>in conjunction with all<br>permanent restorative<br>techniques. Life 2 is a two-part,<br>base/catalyst- paste/paste<br>system. The two-part system is<br>packaged in tubes. The product<br>is available in two viscosities,<br>Fast Set and Regular Set. | Life Regular Set/Life Fast Set<br>are hard setting Calcium<br>Hydroxide cavity liners and pulp<br>capping agents to be used in<br>conjunction with all permanent<br>restorative techniques. Life is a<br>two-part, base/catalyst-<br>paste/paste system. The two-<br>part system is packaged in tubes.<br>The product is available in two<br>viscosities, Fast Set and Regular<br>Set. | | Common<br>Name | Dental Cavity Liner and Pulp<br>Capping Agent | Dental Cavity Liner and Pulp<br>Capping Agent | | Classification<br>Name | Liner, Cavity, Calcium<br>Hydroxide per CFR §<br>872.3250 | Liner, Cavity, Calcium<br>Hydroxide per CFR § 872.3250 | | Class | II | II | | Product Code | EJK | EJK | | Base Formula | Formula per K012717 | No Change from K012717 | | Catalyst<br>Formula for<br>Life Fast Set<br>(PN 16530)<br>Only | Contains 2-5% Fumed Silica<br>Aerosil R972,<br>CAS# 68611-44-9 | Contains 2-5% Fumed Silica<br>Cab-o-sil TS720,<br>CAS#67762-90-7 | | Manufacturing<br>Location | Romulus, MI | Scafati, Italy | | Packaging | Laminate Tubes | Polyfoil Tubes | # Table 8.1: Predicate Life 2 (K012717) and Proposed Life Fast Set and Regular Set ## Conclusion The modification of Life Fast Set (PN 16530) to replace the Fumed Silica, the move of manufacturing locations to Scafati, Italy, and the change to the packaging does not affect the intended use of the device nor does it alter the fundamental scientific technology of the device. The nonclinical testing demonstrates that the Proposed Life Regular Set/ Life Fast Set performs as well as the predicate device. Proposed Life Regular Set/Life Fast Set is substantially equivalent to the predicate Life 2 (K012717).