Elements

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus with three intertwined snakes and three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 28, 2015 Pac-Dent International, Inc. Ms. Wenying Zhu Materials Engineer 21038 Commerce Point Drive Walnut, CA 91789 Re: K151150 Trade/Device Name: ElementsTM Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Codes: ELW Dated: April 24, 2015 Received: April 30, 2015 #### Dear Ms. Zhu: 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. Isting 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. {1}------------------------------------------------ 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/ResourcesforYou/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 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/ResourcesforYou/Industry/default.htm. > Sincerely yours. lina Kiana -S for 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}------------------------------------------------ Image /page/2/Picture/0 description: The image is a logo for PacDent International, Inc. The logo is set against an orange background. The words "PacDent" are in a bold, sans-serif font, with a curved line underneath. Below "PacDent" is the text "International, Inc." and "passion for excellence..." in a smaller font. Pac-Dent International, Inc. 21038 Commerce Pointe Dr. Walnut = California = 91789 t: 909.839.0888 f: 909.839.0881 www.pac-dent.com Section III # Indications for Use Statement 510(k) Number (if known): _K151150 Device Name: __ Elements™ Indications for Use: Elements™ is intended for use with all crown and bridge, occlusal and implant impression techniques to reproduce the structure of a patient's teeth and gums. Prescription Use _________________ OR Over-The-Counter Use {3}------------------------------------------------ Image /page/3/Picture/0 description: The image is a logo for PacDent International, Inc. The logo is set against an orange background. The words "PacDent" are in a bold, black font, with a stylized swoosh underneath. Below that, in a smaller font, it says "International, Inc." and "passion for excellence..." # Pac-Dent International, Inc. 21038 Commerce Pointe Dr. Walnut = California = 91789 t: 909.839.0888 f: 909.839.0881 www.pac-dent.com Section IV # 510(k) Summary #### Submitter: Pac-Dent International, Inc. 670 Endeavor Circle Brea, CA 92821 # Contact Person: Wenying Zhu Materials Engineer 909-839-0888 ext.111 #### Date Summary Prepared: July 2015 Device Name Trade Name: Elements™ Common Name: Dental Impression Material Device Classification: Class II Classification Product Code: ELW Classification Name: Material, Impression, per 21 CFR 872.3660 #### Predicate Device Take 1 (K091613) #### Description of Device Elements™ is an addition-reaction base/catalyst polyvinylsiloxane dental impression material intended as an alternative to traditional alginate materials. It is available in regular set and fast set. Both are available in light body, regular body/monophase and heavy body. #### Indications for Use Elements™ is intended for use with all crown and bridge, occlusal and implant impression {4}------------------------------------------------ Image /page/4/Picture/0 description: The image is a logo for PacDent International, Inc. The logo is set against an orange background. The words "PacDent" are in a bold, black font, with a white swoosh underlining the text. Below "PacDent" is the text "International, Inc." and the phrase "passion for excellence..." # Pac-Dent International, Inc. 21038 Commerce Pointe Dr. Walnut = California = 91789 t: 909.839.0888 f: 909.839.0881 www.pac-dent.com techniques to reproduce the structure of a patient's teeth and gums. ### Summarv of Biocompatibilitv Tests The biocompatibility of Elements™ was found to be substantially equivalent to the predicate based on a risk assessment done per ISO 10993-1 and the identification of legally marketed predicate devices for all ingredients in the chemical composition. | Descriptive<br>Information | Subject Device | Predicate Device | Summary | |-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for<br>Use | Elements ™ | Take 1 (K091613) | | | | Elements™ is intended for use<br>with all crown and bridge,<br>occlusal and implant<br>impression techniques to<br>reproduce the structure of a<br>patient's teeth and gums. | Take 1 is an addition-cure vinly<br>polysiloxane dental impression<br>material that is used for all crown<br>and bridge, edentulous, orthodontic<br>and implant impression techniques. | The indications for<br>use of the subject<br>and predicate<br>devices is to<br>reproduce the<br>structure of a<br>patient's teeth and<br>gums, including but<br>not limited to the<br>applications listed in<br>the indications for<br>use. | | Composition of<br>Materials | Vinly polysiloxane<br>Filler<br>Pigments | Vinly polysiloxane<br>Filler<br>Pigments | The composition of<br>the subjective and<br>predicate devices<br>are the same | | Mode of Use | 1. Light body (Type 3)<br>A low viscosity impression<br>material used to capture<br>extraordinary subgingival<br>details.<br>2. Regular body/Monophase<br>(Type 2)<br>A medium viscosity | 1. Take 1 Light body/Regular body<br>wash:<br>A very hydrophilic impression<br>material used in heavy/wash or<br>putty/wash impression procedures<br>and capable of capturing<br>extraordinary subgingival details. It<br>is used in crown and bridge and all | The nomenclature is<br>different between<br>the subjective and<br>predicate devices.<br>According to the<br>description and<br>bench test result,<br>subjective device's | #### Comparison of Technological Characteristics {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for PacDent International, Inc. The logo is set against an orange background. The words "PacDent" are in a large, bold, black font, with a white swoosh underneath. Below that, in a smaller font, are the words "International, Inc." and "passion for excellence..." Pac-Dent International, Inc. 21038 Commerce Pointe Dr. Walnut ▪ California ▪ 91789 ### t: 909.839.0888 f: 909.839.0881 www.pac-dent.com | | monophase impression<br>material used in single step<br>impression procedures.<br>3. Heavy body (Type 1)<br>A heavy body impression<br>material used as base in<br>two-step heavy-wash<br>applications. | high precision applications.<br>2. Take 1 Medium body:<br>A medium viscosity monophase<br>impression material with superior<br>mechanical strength used in single<br>step impression procedures such<br>as mouth guards, night guards,<br>orthodontic, and edentulous<br>applications.<br>3. Take 1 Tray (heavy body)<br>A heavy body impression material<br>combining strength, elasticity and<br>dimensional stability to deliver the<br>most accurate impressions. It is<br>used in two-step heavy-wash<br>applications such as for crown and<br>bridge procedures. | light body is<br>comparable to<br>predicate device's<br>light body/regular<br>body wash, regular<br>body/monophase is<br>comparable to<br>medium body and<br>heavy body is<br>comparable to tray.<br>The classification of<br>the subjective<br>device is also<br>complied with ISO<br>4823-2000 (Type 1-<br>Type 3). | |-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | FDA-Recognized<br>Standards | ISO 4823-2000 | ISO 4823-2000 | Claims are the<br>same | ## Comparison of physical properties | | ElementsTM | | Take 1 (K091613) | | | | |------------------------------|---------------|-------------------------------|------------------|-------------------------|----------------|------------------------------------| | Test Method<br>ISO 4823-2000 | Heavy<br>body | Regular<br>body/Monop<br>hase | Light body | Tray<br>(heavy<br>body) | Medium<br>body | Light<br>body/Regular<br>body wash | | Detail Reproduction | PASS | PASS | PASS | PASS | PASS | PASS | | Linear Dimensional | 0.14% | 0.05% (0.02) | 0.08% | 0.03% | 0.07% | 0.07% (0.01) | | Change | (0.01) | | (0.02) | (0.01) | (0.01) | | | Compatibility with<br>Gypsum | PASS | PASS | PASS | PASS | PASS | PASS | | Elastic Recovery | 99.7 (0.1) | 99.6 (0.3) | 99.8 (0.1) | 99.45 (0.1) | 99.65 (0.1) | 99.84 (0.1) | | Strain-In-Compression | 2.85 (0.1) | 3.67 (0.13) | 4.93 (0.1) | 2.92 (0.25) | 3.4 (0.15) | 5.4 (0.15) | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image is a logo for PacDent International, Inc. The logo is set against an orange background. The words "PacDent" are in a bold, black font, with a registered trademark symbol next to it. Below that, the words "International, Inc." are in a smaller, lighter font, and below that, the words "passion for excellence..." are in a similar font. Pac-Dent International, Inc. 21038 Commerce Pointe Dr. Walnut = California = 91789 t: 909.839.0888 f: 909.839.0881 www.pac-dent.com #### Substantial Equivalence In summary, this submission demonstrates that Elements™ is substantially equivalent to the identified predicated product for its intended use and technological characteristics. Non clinical performance testing per ISO 4823-2000 substantiates equivalence in terms of detail reproduction, linear dimensional change, compatibility with gypsum, elastic recovery and strain in compression. No clinical testing was performed.