Parkell Self-Adhesive Cement

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. January 20, 2022 Parkell, Inc La-Shaunda Joseph Regulatory/Compliance Manager 300 Executive Drive Edgewood, New York 11717 Re: K210259 Trade/Device Name: Parkell Self-Adhesive Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: January 4, 2022 Received: January 6, 2022 # Dear La-Shaunda Joseph: 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. 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 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 {1}------------------------------------------------ 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 (QS) 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, For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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) K210259 Device Name Parkell Self-Adhesive Cement Indications for Use (Describe) Parkell Self-Adhesive Cement is intenced for the cementation of induding ceramic, zirconia, composite, and metal-based inlays, onlays, crowns, bridges, and posts. 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. 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Submitter Parkell, Inc. 300 Executive Drive Edgewood, NY 11717 Phone: 631-389-1560 ljoseph@parkell.com Contact Person: La-Shaunda Joseph – Compliance and Regulatory Manager Date of Summary Preparation: January 19, 2022 # 2. Type of Submission: Traditional 510(k) ### 3. Device | Device Proprietary Name: | Parkell Self-Adhesive Cement | |--------------------------|------------------------------| | Common or Usual Name: | Self-Adhesive Cement | | Classification Name: | Dental Cement | | Regulation Number: | 21 CFR 872.3275 | | Product Code: | EMA | | Device Classification | II | # 4. Primary Predicate Device Self-adhesive Cement (K073173, Dentsply International) (now marketed by Dentsply under the trade name "SmartCem2"). # 5. Device Description Parkell Self-Adhesive Cement is a two-component, dual-cured, self-adhesive resin cement. It is designed for luting of indirect restorations (inlays, onlays, crowns, bridges, and endodontic posts) made of metal alloys, composite resins, porcelain, lithium disilicate or zirconia. The material also exhibits high bond strength and is radiopaque to allow visibility of excess in sub-gingival areas. Parkell Self-Adhesive Cement will cure in 10 seconds with a dental curing light emitting blue light at 430 - 480 nm and a minimum intensity of 600 mW/cm². The product will self-cure in 3-4 minutes at mouth temperature. Parkell Self-Adhesive Cement will be provided in 5 mL auto-mix syringes. The device comprises catalyst and base components, which are combined just prior to use via a static (1:1) mixing tip which is affixed to the dual chamber syringe. Image /page/3/Picture/15 description: The image shows the logos for DirectaDentalGroup and some of its brands. The DirectaDentalGroup logo is in white text on a dark blue background. Below the DirectaDentalGroup logo are the logos for DIRECTA, topdental, ORSING, and parkell. The DIRECTA logo also includes the website address directadental.com. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "parkell" in a dark blue sans-serif font. The letters are rounded and have a uniform thickness. A small registered trademark symbol is located to the right of the second "l" in the word. The background is white. ## 6. Indications for Use Parkell Self-Adhesive Cement is intended for the cementation of indirect restoratives including ceramic, zirconia, composite, and metal-based inlays, onlays, crowns, bridges, and posts. ### 7. Comparison of Technological Characteristics The standards applicable to the subject device and to the comparison of technological characteristics referenced within the submission, include ISO 4049:2019 Dentistry - Polymer-based restorative materials, ISO 11405:2015 Dentistry - Testing of adhesion to tooth structure, ISO 16506:2017 Dentistry. Polymer-based luting materials containing adhesive components, ISO 13116:2014 Dentistry — Test method for determining radio-opacity of materials and ISO 23317:2014 Implants for surgery - In vitro evaluation for apatite-forming ability of implant materials. Information provided in these 510(k) submissions demonstrates that Parkell Self-Adhesive Cement is substantially equivalent to the Predicate Self-adhesive Cement (K073173) (now marketed by Dentsply under trade name, SmartCem2), in terms of similar intended use and technological characteristics (e.g. Compressive Strength, Depth of Cure, film thickness, flexural strength, radiopacity, water sorption and solubility), wherein Parkell Self-Adhesive Cement differs from the Predicate Device in the minor ways detailed in this Submission. Parkell's Self-Adhesive Cement has expanded its intended use beyond the predicate device to include zirconia. Parkell has conducted the necessary tests to illustrate the efficacy of the Bonding Substrates to Zirconia. Any differences between the Device and the Predicate Device, for purposes of this 510(k) submission, do not raise new questions of efficacy or safety. Thus, this submission demonstrates the substantial equivalence between Parkell Self-Adhesive Cement to the Predicate device. A brief comparison of Parkell Self-Adhesive Cement to the Primary Predicate is provided in Table 5-A below. | Property | Parkell Device<br>Self-Adhesive Cement (Parkell,<br>Inc.) | Primary Predicate Device<br>510(k) no. K073173, SmartCem2,<br>filed as "Self-adhesive Cement" | |-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended uses | Parkell Self-Adhesive Cement is<br>intended for the cementation of<br>indirect restorations including<br>Ceramic, Zirconia, Composite<br>and Metal-based inlays, onlays,<br>Crowns, Bridges, and posts. | Self-adhesive Resin Cement is<br>intended for the cementation of<br>indirect restorations including<br>Ceramic, Composite and Metal-<br>based inlays, onlays, Crowns,<br>Bridges and posts. | | Classification Product Code | EMA | EMA | | Regulation Number | 872.3275 | 827.3275 | | Principle of operation | Self-adhesive cementation of<br>indirect dental restorations | Self-adhesive cementation of<br>indirect dental restorations | | Material form | Paste | Paste | | Table 5-A: Comparison of Subject and Predicate Devices | | | |---------------------------------------------------------------------------------------------------|----------------------------------|------------------| | | | | | Base/Catalyst Ratio | 1:1 | 1:1 | | Polymerization Method | Dual-Cure | Dual-Cure | | lons released | Fluoride<br>Calcium<br>Phosphate | Fluoride | | Radiographic Appearance | Radiopaque | Radiopaque | | Delivery System | Auto-mix syringe | Auto-mix syringe | | Film Thickness (Microns)<br>Pass/Fail Criteria: ≤ 50<br>microns | ≤ 50 microns | ≤ 50 microns | | Working time (seconds) @<br>35 C Pass/Fail Criteria: ≤ 60<br>seconds | ≤ 60 seconds | ≤ 60 seconds | | Setting time (minutes) @ 35<br>C Pass/Fail Criteria: ≤ 10<br>minutes | ≤ 10 minutes | ≤ 10 minutes | | Flexural strength LC (MPa)<br>Pass/Fail Criteria: ≥ 50 MPa | ≥ 50 MPa | ≥ 50 MPa | | Flexural Strength SC (MPa)<br>Pass/Fail Criteria: ≥ 50 MPa | ≥ 50 MPa | ≥ 50 MPa | | Compressive Strength LC<br>Pass/Fail Criteria: ≥ 200 MPa | ≥ 200 MPa | ≥ 200 MPa | | Water Sorption (ug/mm³)<br>Pass/Fail Criteria: ≤ 40<br>ug/mm³ | ≤ 40 ug/mm³ | ≤ 40 ug/mm³ | | Water Solubility (ug/mm³)<br>Pass/Fail Criteria: ≤ 7.5<br>u/mm³ | ≤ 7.5 u/mm³ | ≤ 7.5 u/mm³ | | Radiopacity (% Al) Pass/Fail<br>Criteria: ≥ 100 %Al | ≥ 100 %Al | ≥ 100 %Al | | Depth of Cure (mm) Pass/Fail<br>Criteria: ≥ 1mm | ≥ 1mm | ≥ 1mm | | Diametral Tensile Strength<br>(MPa) Pass/Fail Criteria: ≥ 30<br>MPa | ≥ 30 MPa | ≥ 30 MPa | | Barcol Hardness after 20<br>minutes @35c (MPa)<br>Pass/Fail Criteria: > 50 MPa | > 50 MPa | > 50 MPa | | Barcol Hardness after 20 secs<br>Light Cure each surface<br>(MPa) Pass/Fail Criteria: > 60<br>MPa | > 60 MPa | > 60 MPa | | Film Thickness (Microns)<br>Pass/Fail Criteria: ≤ 50<br>microns | ≤ 50 microns | ≤ 50 microns | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "parkell" in a dark blue sans-serif font. The letters are closely spaced and have a rounded appearance. A small registered trademark symbol is located to the right of the second "l" in the word. The background is plain white. # Table 5-B: Comparison of Subject and Predicate Devices: Bond Strength to different Substrate {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "parkell" in a bold, sans-serif font. The word is in a dark blue color, and there is a registered trademark symbol to the right of the word. The background is white, which makes the word stand out. | | | Parkell Device<br>Self-Adhesive<br>Cement<br>(Parkell, Inc.) | Predicate Device<br>510(k) no. K073173,<br>SmartCem2, filed as<br>"Self-Adhesive<br>Cement" | |------------------------------------------------------|-----------|--------------------------------------------------------------|---------------------------------------------------------------------------------------------| | Substrate Pass/Fail Requirements | | Bond Strength (MPa) | Bond Strength (MPa) | | Bonding Substrates to Composite Stumps | Treatment | | | | Dentin LC (Pass/Fail Criteria: ≥ 6 MPa) | None | ≥ 6 MPa | ≥ 6 MPa | | Dentin LC (Pass/Fail Criteria: ≥ 10 MPa) | PBA | ≥ 10 MPa | ≥ 10 MPa | | Dentin SC (Pass/Fail Criteria: ≥ 3 MPa) | None | ≥ 3 MPa | ≥ 3 MPa | | Enamel LC (Pass/Fail Criteria: ≥ 10 MPa) | None | ≥ 10 MPa | ≥ 10 MPa | | Enamel LC (Pass/Fail Criteria: ≥ 10 MPa) | H3PO4 | ≥ 10 MPa | ≥ 10 MPa | | Enamel SC (Pass/Fail Criteria: ≥ 3 MPa) | None | ≥ 3 MPa | ≥ 3 MPa | | Lithium Disilicate LC (Pass/Fail Criteria: ≥ 5 MPa) | Silane | ≥ 5 MPa | ≥ 5 MPa | | Lithium Disilicate LC (Pass/Fail Criteria: ≥ 10 MPa) | HF | ≥ 10 MPa | N/A | | Zirconia LC (Pass/Fail Criteria: ≥ 10MPa) | SB | ≥ 10 MPa | ≥ 10 MPa | | Zirconia LC (Pass/Fail Criteria: ≥ 10 MPa) | PBA | ≥ 10 MPa | N/A | | Zirconia LC (Pass/Fail Criteria: ≥ 10MPa) | HF | ≥ 10 MPa | N/A | | Zirconia SC (Pass/Fail Criteria: ≥ 5 MPa) | SB | ≥ 5MPa | ≥ 5MPa | | Porcelain LC (Pass/Fail Criteria: ≥ 10MPa) | SB | ≥ 10 MPa | ≥ 10 MPa | | Porcelain LC (Pass/Fail Criteria: ≥ 10 MPa) | Silane | ≥ 10 MPa | N/A | | Porcelain LC (Pass/Fail Criteria: ≥ 10 MPa) | HF | ≥ 10 MPa | N/A | | Porcelain SC (Pass/Fail Criteria: ≥ 5 MPa) | HF | ≥ 5 MPa | N/A | | Palladium LC (Pass/Fail Criteria: ≥ 10 MPa) | SB | ≥10 MPa | ≥10 MPa | | Titanium LC (Pass/Fail Criteria: ≥ 10 MPa) | SB | ≥10 MPa | ≥10 MPa | | Titanium SC (Pass/Fail Criteria: ≥ 5 MPa) | SB | ≥ 5 MPa | ≥ 5 MPa | | Cobalt LC (Pass/Fail Criteria: ≥ 10 MPa) | SB | ≥ 10MPa | ≥ 10MPa | | Cobalt SC (Pass/Fail Criteria: ≥ 5 MPa) | SB | ≥ 5 MPa | ≥ 5 MPa | As seen above, the differences between the subject and primary predicate devices are limited to minor differences materials of construction and material form. These technological differences do not raise issues with respect to substantial equivalence and are addressed by comparative performance data provided within this submission. #### 8. Reference Devices A table of the References devices used in this submission is shown below: | Reference Device/Source | FDA 510(k) number | |-------------------------------------------------------|-------------------| | HelioSeal F (Ivoclar) | K190339 | | Activa Pit and Fissure Sealant (Pulpdent) | K172169 | | Clearfield Universal Bond Quick (Kuraray Dental Inc.) | K161042 | | Brush&Bond 4-Meta Bonding System (Parkell Inc.) | K151518 | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "parkell" in a dark blue sans-serif font. The letters are closely spaced and have a rounded appearance. A small registered trademark symbol is located to the right of the second "l" in "parkell". | Smartemp X1(Parkell Inc.) | K190930 | |---------------------------------------------------|---------| | HyperFil-LV (Parkell Inc.) | K182296 | | ESPE's Adper Easy Bond L-Pop dental adhesive (3M) | K020946 | | ESPE's Filtek Bulk Fill Posterior (3M) | K141081 | | RelyX luting plus automix (3M) | K111185 | | Aura (SDI) | K102984 | | Sonicfill 2 (Kerr) | K143209 | #### 9. Performance Testing The following non-clinical studies were performed: - Performance and Physical Properties - Bond strength using different substrates. O - O Compressive strength - Water sorption and solubility O - Depth of Cure O - Barcol Hardness O - O Flexural strength - Radiopacity O - Working Time/Setting Time at Room Temperature and oral temperature O - O Calcium release - Fluoride release O - Phosphate release O - Film Thickness O - O Viscosity - O Shelf Life - Bioactivity O - O Microleakage - Ions Release and Recharge O - Gap Closure O #### 10. Biocompatibility and Bench Data An evaluation of biocompatibility was addressed for the safety of Parkell Self-Adhesive Cement in accordance with ISO 10993-1:2018, ISO 10993-3:2014, ISO 10993-5: 2009, ISO 10933-6:2016, ISO 10993-10: 2010, ISO 10993-11:2017, ISO 10993-12: 2012, ISO 10993-33:2015 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" (September 4, 2020). The following table shows the tests that were conducted on the subject device. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "parkell" in a dark blue sans-serif font. The letters are closely spaced and have a rounded appearance. A small registered trademark symbol is located to the right of the word. | Cytotoxicity | ISO 10993-5 | |---------------------------------------|--------------| | Acute Systemic Toxicity Test | ISO 10993-11 | | Primary oral (Buccal) irritation test | ISO 10993-10 | | Genotoxicity Test | ISO 10993-3 | | Sensitization Test | ISO 10993-10 | | Implantation Test | ISO 10993-6 | The conclusion of the evaluation is that Parkell Self-Adhesive Cement is substantially equivalent to the predicate device in terms of biocompatibility. ### 11. 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. #### 12. Statement of Substantial Equivalence: The information provided above supports that Parkell Self-Adhesive Cement is substantially equivalent to the Primary Predicate. Although minor differences in design and technology exist between the subject and primary predicate devices, the testing supports that these differences do not raise questions as to the substantial equivalence between the devices. Therefore, it is concluded that Parkell Self-Adhesive Cement is substantially equivalent to the Primary Predicate.