SmarTemp X1

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. September 5, 2019 Parkell, Inc. David Mott Vice President- Legal, R&D, and Regulatory 300 Executive Drive Edgewood, New York 11717 Re: K190930 Trade/Device Name: SmarTemp X1 Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown And Bridge Resin Regulatory Class: Class II Product Code: EBG, POW Dated: June 5, 2019 Received: June 7, 2019 Dear David Mott: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael Adjodha Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K190930 Device Name SmarTemp® X1 Indications for Use (Describe) SmarTemp® X I is a self-curing composite for the fabrication of temporary crowns and bridges, inlays and veneers. SmarTemp® X1 is intended for the fabrication of: temporary crowns, bridges, inlays, long-term temporaries, and temporary veneers. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------|--| | <div><span style="font-size:10pt"><span style="font-family:Wingdings"></span></span></div> | | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Submitter Parkell, Inc. 300 Executive Drive Edgewood, NY 11717 Phone: 631-389-1545 dmott@parkell.com Contact Person: David Mott, Vice President - Legal, R&D, and Regulatory Date of Original Submission: April 9, 2019 Date of Latest Revision: September 5, 2019 #### 2. Device | Device Proprietary Name: | SmarTemp® X1 | |--------------------------|----------------------------------| | Common or Usual Name: | Temporary crown and bridge resin | | Classification Name: | Temporary crown and bridge resin | | Regulation Number: | 21 CFR 872.3770 | | Product Code: | EBG | | Device Classification | II | #### 3. Predicate Device Luxatemp® Ultra/Star, K101710, DMG USA, Inc. #### 4. Device Description SmarTemp® X1 is a self-curing, resin-based composite, suitable for the fabrication of temporary crowns, bridges, inlays, onlays, and veneers. It is a bis-acryl resin-based material comprising a 10:1 ratio of base to catalyst components, which when expressed by the user from dual-chamber syringes or cartridges mix through standard snap-in accessory mixing tips. SmarTemp® X1 self-cures in approximately 6 minutes at mouth temperature. SmarTemp® X1 is packaged in any standard, opaque, dual-chamber syringe or cartridge suitable for containing a 10:1 ratio of base and catalyst components, respectively. The syringe or cartridge is accompanied by standard snap-in automix tips. ### 5. Indications for Use SmarTemp® X1 is a self-curing composite for the fabrication of temporary crowns and bridges, inlays, onlays and veneers. SmarTemp® X1 is intended for the fabrication of: temporary crowns, bridges, inlays, onlays, long-term temporaries, and temporary veneers. #### 6. Comparison of Technological Characteristics Information provided in this 510(k) submission demonstrates that SmarTemp® X1 is substantially Image /page/3/Picture/17 description: The image shows the logo for DirectaDentalGroup. Below the main logo are the logos for DIRECTA, topdental, ORSING, and parkell. The logos are all white against a dark blue background. The DirectaDentalGroup logo is in a larger font than the other logos. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Parkell Inc. The word "parkell" is written in a bold, sans-serif font, with the letters closely spaced together. To the right of "parkell", the word "inc." is written in a smaller, cursive font. The logo is black and white. equivalent to the Predicate Device (Luxatemp® Ultra/Star, K101710) in terms of critical properties for provisional materials, such as, for example, compressive strength, volumetric shrinkage, water sorption, and water solubility. As is demonstrated throughout this submission and below in Table 5-A, any differences between the Device and the Predicate Device in the chemical make-up and/or physical properties, do not raise questions of substantial equivalence. Thus, this submission demonstrates the substantial equivalence between SmarTemp® X1 and the Predicate Device. A brief comparison of SmarTemp® X1 to the Predicate Device is provided below: | Property | SmarTemp® X1<br>(Parkell, Inc.) | Predicate Device<br>Luxatemp® Ultra/Star<br>(K101710, DMG USA, Inc.) | |------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended uses | SmarTemp® X1 is a self-curing composite for the fabrication of temporary crowns and bridges,inlays, onlays and veneers.<br><br>SmarTemp® X1 is intended for the fabrication of:<br>• temporary crowns<br>• bridges<br>• inlays<br>• onlays<br>• long-term temporaries<br>• temporary veneers. | Luxatemp® Ultra/Star is a self-curing or dual-curing composite for the fabrication of temporary crowns and bridges, inlays, onlays and veneers.<br><br>Luxatemp® Ultra/Star is intended for the fabrication of:<br>• temporary crowns<br>• bridges<br>• inlays<br>• onlays<br>• long-term temporaries<br>• temporary veneers.<br><br>Luxatemp® Ultra/Star is also intended for incorporation of most mechanically anchored attachment components into the acrylic base of a denture, an overdenture, or partial denture. | | Classification Product Code | EBG | EBG | | Regulation Number | 21 CFR 872.3770 | 21 CFR 872.3770 | | Principle of operation | Temporary crown and bridge resin | Temporary crown and bridge resin | | Base/Catalyst Ratio | 10:1 | 10:1 | | Self-curing | Yes | Yes | | Radiopaque | Yes | Yes | | Exhibits fluorescence | Yes | Yes | | Compressive Strength<br>(>300 MPa) | >300 MPa | >300 MPa | | Flexural Strength<br>(>100 MPa) | >100 MPa | >100 MPa | Table 5-A: {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Parkell Inc. The logo is in black and white, with the word "parkell" in a bold, sans-serif font. The letters are all lowercase, and the "p" is slightly larger than the other letters. To the right of "parkell" is the word "inc." in a smaller, italicized font. ### Table 5-A (continued): | Property | SmarTemp® X1<br>(Parkell, Inc.) | Predicate Device<br>Luxatemp® Ultra/Star<br>(K101710, DMG USA, Inc.) | |------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------| | Shrinkage<br>(< 3%) | < 3% | < 3% | | Water Sorption<br>(≤ 40 µg/mm³) | ≤ 40 µg/mm³ | ≤ 40 µg/mm³ | | Water Solubility<br>(≤ 7.5 µg/mm³) | ≤ 7.5 µg/mm³ | ≤ 7.5 µg/mm³ | | Chemical composition | dimethacrylate based<br>composite resin, comprising filler<br>component(s) | dimethacrylate based<br>composite resin, comprising filler<br>component(s) | #### Non-clinical Performance Testing 7. #### a. Biocompatibility An evaluation of biocompatibility was conducted for SmarTemp® X1 in accordance with ISO 10993-1: 2009, ISO 10993-3: 2014, ISO 10993-5: 2009, ISO 10993-10: 2010, ISO 10993-11:2017, ISO 10993-12: 2012, ISO 10993-33: 2015, BS ISO 23317:2014, ISO/IEC 17025:2017, OECD 471, and the FDA's Guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (June 16, 2016). #### b. Shelf life Testing was conducted to evaluate the shelf life of SmarTemp® X1. #### C. Bench Performance Testing was conducted on both SmarTemp® X1 and the predicate device (Luxatemp® Ultra/Star, K101710) to evaluate critical properties including compressive strength, volumetric shrinkage, water sorption, and water solubility. #### 8. Clinical Performance Data There was no clinical testing required to support the Device as the intended uses are equivalent to the Predicate Device. These types of devices have been on the market for many years with no reported adverse events. The non-clinical testing detailed in this submission supports the substantial equivalence of the Device. #### 9. Statement of Substantial Equivalence: The information provided above supports that SmarTemp® X1 is substantially equivalent to the Predicate Device. Although minor differences in design and technology may exist between the subject and predicate devices, the testing supports that these differences do not raise any questions with respect to substantial equivalence. Therefore, it is concluded that SmarTemp® X1 is substantially equivalent to the Predicate Device.