BA Pit & Fissure Sealant

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 8, 2019 Apex Dental Materials, Inc. Scott Lamerand Owner 330 Telser Road Lake Zurich, Illinois 60047 Re: K190998 Trade/Device Name: BA Pit & Fissure Sealant Regulation Number: 21 CFR 872.3765 Regulation Name: Pit and fissure sealant and conditioner Regulatory Class: Class II Product Code: EBC Dated: August 8, 2019 Received: August 13, 2019 Dear Scott Lamerand: 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 {1}------------------------------------------------ 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) 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, for Srinivas Nandkumar, Ph.D. Acting 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 Form Approved: 0MB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K190998 Device Name BA Pit & Fissure Sealant Indications for Use (Describe) BA Pit & Fissure Sealant is intended to seal pit and fissure depressions/faults in the biting surfaces of teeth. For dental professional use only. Type of Use (Select one or both. as applicable): | <div> <span> <svg class="bi bi-check-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> <path d="M10.97 4.97a.75.75 0 0 1 1.071 1.05l-3.992 4.99a.75.75 0 0 1-1.08.02L4.324 8.384a.75.75 0 1 1 1.06-1.06l2.094 2.093 3.473-4.425a.235.235 0 0 1 .02-.022z" fill-rule="evenodd"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ### 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}------------------------------------------------ ## K190998 # 510(k) Summary for BA Pit & Fissure Sealant # Abbreviated 510(k) Submission #### Applicant 1. | Submitter's Name: | Scott Lamerand<br>Alex Johnson<br>John Baeten | Date Summary Prepared: | Nov. 7, 2019 | |-------------------|-----------------------------------------------------------------------------------------------------------|------------------------|----------------| | Address: | Apex Dental Materials, Inc<br>330 Telser Road<br>Lake Zurich, IL 60047<br>Registration Number: 3004402215 | Contact Person: | Scott Lamerand | | Phone: | 847-719-1133 | | | | Email: | Scott.Lamerand@apexdentalmaterials.com | | | | Fax: | 847-719-1122 | | | #### 2. Device Name Proprietary Name: BA Pit & Fissure Sealant Common Name: Sealant, Pit And Fissure, And Conditioner Review Panel: Dental Product Code: EBC Device Class: Class II #### 3. Predicate Device Pulpdent (Activa) Pit & Fissure Sealant with MCP (K172169) by Pulpdent Corporation - o Common Name: Sealant, Pit And Fissure, And Conditioner - Product Code: EBC O - o Device Class: Class II ## Reference Device Prevent Seal (K122521) by Itena Clinical - o Common Name: Sealant, Pit And Fissure, And Conditioner - o Product Code: EBC - Device Class: Class II O {4}------------------------------------------------ #### 4. Device Description Pit and Fissure sealants are used as a preventive measure to fill defects and prevent decay within crevices, voids or fissures on the surface of teeth. These voids are more challenging to keep free of substances that can lead to caries and eventual breakdown of tooth structure. BA Pit & Fissure Sealant is a material designed to fill these voids with a wear resistant material, ultimately preserving natural tooth structure. BA Pit & Fissure Sealant is a light activated / photopolymerizable, glass filled, urethane dimethacrylate material that is placed onto an etched enamel surface and light activated for 20 seconds. The result after application is a tooth that has been sealed with a tough, wear resistant material. This is the only 510(k) for this medical device, no prior 510(k)s have been submitted. #### ട്. Intended Use / Indication for Use BA Pit & Fissure Sealant is intended to seal pit and fissure depressions/faults in the enamel, in the biting surfaces of teeth. For dental professional use only. #### 6. Technological Characteristics and Substantial Equivalence | | Subject Device | Predicate Device | Reference Device | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | BA Pit & Fissure<br>Sealant<br>(K190998) | Pulpdent (Activa) Pit<br>& Fissure Sealant<br>with MCP<br>(K172169) | Prevent Seal<br>(K122521) | | Common Name | Pit and Fissure<br>Sealant and<br>Conditioner | Pit and Fissure<br>Sealant and<br>Conditioner | Pit and Fissure Sealant and<br>Conditioner | | Device<br>Classification | Class II | Class II | Class II | | CFR Section | 21 CFR 872.3765 | 21 CFR 872.3765 | 21 CFR 872.3765 | | Product Code | EBC | EBC | EBC | | Surface applied to: | Prepared Enamel | Prepared Enamel | Prepared enamel | | Number of layers | 1 | 1 | 1 | | Method of activation | Light activated only | Light activated only | Light activated only | | Duration of<br>activation | 20 seconds | 20 seconds | 20 seconds | | Working Time | Unlimited | Unlimited | Unlimited | | Indications for Use | BA Pit & Fissure<br>Sealant is intended<br>to seal pit and<br>fissure<br>depressions/faults in<br>the enamel, in the<br>biting surfaces of<br>teeth. For dental<br>professional use<br>only. | Pulpdent's Activa Pit<br>and Fissure Sealant<br>with MCP is intended<br>to seal pit and fissure<br>depressions/faults in<br>the enamel, in the<br>biting surfaces of<br>teeth. For dental<br>professional use only. | Prevent Seal is used by dental<br>professionals primarily in young<br>children:<br>-To fill and seal pit and fissure<br>depressions (faults in the<br>enamel) of teeth to prevent<br>cavities:<br>-Covering layer or "initial layer"<br>in the fabrication of esthetically<br>demanding composite<br>restorations; and | {5}------------------------------------------------ | | Subject Device | Predicate Device | Reference Device | |-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------| | | | | -For repairs of composite<br>restorations (in particular filling<br>of voids, leveling out of<br>porosities and minor chips) | | Appearance prior to<br>light activation | Milky white paste | Tooth shade paste | White paste | | Appearance after<br>light activation | Clear | Clear with tooth<br>shade hue | White / clear | | Sterility | Non-sterile | Non-sterile | Non-sterile | | Prescription / OTC | Prescription | Prescription | Prescription | | Compliance with<br>Standards | ISO 4049:2009<br>(FDA Recognition<br>Number 4-181)<br>ADA Standard 27<br>ISO 6874:2015<br>ISO 14971:2007<br>ISO 14971:2012<br>ISO 7405:2009<br>Guidance for<br>Industry and FDA<br>staff; Dental<br>Composite Resin<br>Devices Premarket<br>Notification<br>[510(k)]<br>Submissions. | ISO 4049:2009 (FDA<br>Recognition Number<br>4-181)<br>ANSI/ADA Standard<br>41<br>ISO 10993-5:2009<br>ISO 7405:1999 &<br>2009<br>Guidance for<br>Industry and FDA<br>staff; Dental<br>Composite Resin<br>Devices Premarket<br>Notification<br>[510(k)]<br>Submissions. | Unknown | | Primary Packaging<br>(**) | 1.2ml PP syringe | 1.2ml PP syringe | 1.2ml PP syringe | | Co-Packaged<br>Accessories (**) | Applicator tips | Applicator tips | Applicator tips | (**) Primary Packaging (i.e. syringe) and applicator tips are Class I medical devices per EIC product code (syringe, periodontic, endodontic, irrigating) and CFR regulation number 872.4565 and are 510(k) exempt. ## Discussion of Similarities between the Subject Device and Predicate Device: - BA Pit & Fissure Sealant has nearly identical indications for use as its predicate device; the only ● differences are the medical device and company names. - BA Pit & Fissure Sealant is classified under product code EBC, with respect to 21 CRF 872.3765 ● and the common name "Pit and Fissure Sealant and Conditioner", which is identical to that of the predicate device. - BA Pit & Fissure Sealant has an unlimited working time, and is applied to prepared enamel, which ● is identical to the predicate device. - Identical to the predicate device, BA Pit & Fissure Sealant is applied in one layer and is light-● activated for 20 seconds by light > 600 mW/cm2 within 350nm -490nm. {6}------------------------------------------------ - BA Pit & Fissure Sealant exhibited a very similar depth of cure to the predicate device. Pulpdent's . Pit & Fissure Sealant with MCP. - o The minor difference between the two devices is not a concern for pit and fissure sealants, since they're used solely on the occlusal surface and in thin layers and does not impact the subject device's suitability for its intended use. - . The composition of BA Pit & Fissure Sealant is identical to existing commercialized medical devices when evaluating components found within both the predicate and reference devices. For example, the predicate device does not contain HEMA is a component within the reference device. - . Identical to the predicate device, BA Pit & Fissure Sealant is packaged within a polypropylene syringe and co-packaged with Class I, 510(k) exempt, applicator tips. - . Identical to the predicate device. BA Pit & Fissure Sealant is commercialized non-sterile, is for prescription use only, and is in compliance with relevant ISO and FDA dental standards and guidances. BA Pit & Fissure Sealant shares similar intended use, technical characteristics, packaging configurations, and compositions to the predicate and reference devices. Therefore, BA Pit & Fissure Sealant is substantially equivalent to the predicate device and poses no additional safety or efficacy risks. ## Discussion of Differences between the Subject Device and Predicate Device: - BA Pit & Fissure Sealant has slightly different physical properties (i.e. diametral tensile strength, and pH) compared to the predicate device. - These differences do not raise any additional concerns and the subject device remains O substantially equivalent to its predicate device. - Through ion release testing, BA Pit & Fissure Sealant released more calcium, phosphate, and fluoride ions than the predicate device. - o This difference does not raise concerns as the recorded release profiles are very low (i.e. ppm or ppb) and calcium, phosphate, and fluoride ion levels are known to be safe in this range. Furthermore, the oral environment naturally experiences normal fluctuations in calcium, phosphate, and fluoride ion concentrations through various daily activities (i.e. eating, drinking beverages, brushing teeth, mouthwashes, etc.). - In summary, substantial equivalence is supported as the subject device and predicate device O released measurable ions in similar concentrations throughout the experiment. ## Conclusion: Taking into consideration the indications for use, application protocol, chemical composition and physical properties of the subject device and reference and predicate devices, the subject device is substantially equivalent to the predicate device. The tables above have provided an overview that details the equivalence. In select instances some comparative data was not available; however, in presenting the available data a comparison of physical properties can be drawn. While select criteria differences are not clinically relevant and do not impact the suitability of the materials for their intended use. Applicable Standards {7}------------------------------------------------ - Dental Composite Resin Devices Premarket Notification [510(k)] Submissions Guidance for ● Industry and FDA Staff, issued on October 26, 2005 - ISO 4049:2009 (FDA Recognition Number 4-181) ● - ADA Standard 27 ● - ISO 6874:2015 ● - ISO 14971:2007 & ISO 14971:2012 ● - ISO 7405:2009 ● #### 7. Non-Clinical Performance Testing and Compliance BA Pit and Fissure Sealant has undergone extensive benchtop to provide evidence that it is substantially equivalent to the predicate device. The following non-clinical tests were conducted to evaluate the functionality, performance, suitability, and substantial equivalence of the subject device to the predicate device: - . Compressive strength - BA Pit & Fissure Sealant exhibited a very similar compressive strengths to the predicate o device and reference device. Therefore, substantial equivalence of the subject device to the predicate device is supported. - Diametral tensile strength ● - BA Pit & Fissure Sealant exhibited similar diametral tensile strength compared to the о predicate device. Therefore, substantial equivalence of the subject device to the predicate device is supported. - Elastic modulus - The subject device's modulus indicates the material is flexible and will absorb significant O forces without reaching permanent deformation. When the material is applied to a tooth surface the level of deformation is limited by the structure of the tooth. With the deformation limited, the BA Pit & Fissure sealant will be able to absorb occlusal forces without experiencing damage. Substantial equivalence of the subject device to the predicate device is supported as the subject device's material properties support efficacious use as a sealant. - Working time - The working time of BA Pit & Fissure Sealant is equivalent to the predicate device, which O also has an unlimited working time following testing in ISO 4049. Therefore, substantial equivalence of the subject device to the predicate device is supported. - Depth of cure - BA Pit & Fissure Sealant exhibited a very similar depth of cure of to the predicate device, O Pulpdent's Pit & Fissure Sealant with MCP, following ISO 6874 testing. The minor difference between the two devices is not a concern for pit and fissure sealants, since they're used solely on the occlusal surface and in thin layers, and this result does not impact the subject device's safety or efficacy. Therefore, substantial equivalence of the subject device to the predicate device is supported. - Film thickness - BA Pit & Fissure Sealant resulted in a film thickness results nearly equivalent to the o reference device, Prevent Seal, following ISO 4049 testing. Therefore, substantial {8}------------------------------------------------ equivalence of the subject device to commercially available devices in the market is supported. - Cytotoxicity ● - Both Embrace (predicate device) and BA Pit and Fissure Sealant (subject device) provided o the same result in cytotoxicity testing. Therefore, this testing confirms that the subject device is substantially equivalent to the predicate device in terms of cytotoxicity. Combined with the 510(k)'s biocompatibility discussion, and longstanding use of similar dental materials and ingredients for over 30 years, Apex concludes that no further biocompatibility testing or clinical evaluation is needed before release of this product to the market. - Accelerated shelf-life ● - o Accelerated shelf-life testing supports an 18 month shelf-life, as all test points to-date have yielded "passing" results. This test report represents an interim analysis of the accelerated shelf-life testing performed to-date, which currently supports an 18 month shelf-life. Accelerated shelf-life testing will continue through 36 months of accelerated aging to provide a suggested shelf-life for BA Pit and Fissure Sealant. An additional test report will be written to summarize the completed accelerated shelf-life testing. Real-time shelf-life testing will be run in parallel to confirm actual shelf-life parameters for this medical device. - Ion release - Both the subject device and predicate device released measurable calcium, phosphate, and O fluoride at each timepoint of the 1 week experiment. - Compared to the predicate device, the subject device released more calcium, phosphate, and o fluoride over the course of the experiment. However, the oral environment naturally experiences normal fluctuations in ion concentrations, therefore, these minor differences do not raise any concerns. In summary, substantial equivalence is supported as the subject device and predicate device released measurable ions throughout the experiment. #### Clinical Performance Testing and Compliance 8. Apex Dental Materials, Inc., concludes that the performed benchtop tests, and longstanding history of these pit and fissure sealants in the dental field, substantial equivalence of the subject device to the predicate device. As such, clinical performance is not deemed necessary. #### 9. Conclusion BA Pit & Fissure Sealant is to be marketed by Apex Dental Materials, Inc. 330 Telser Road, Lake Zurich, IL, 60047, and is substantially equivalent to predicate Pulpdent (Activa) Pit & Fissure Sealant with MCP (K172169). The subject medical device has a nearly identical intended use and technological characteristics to the predicate device, and as such, is substantially equivalent to the predicate device for the described indications. Any differences between the subject medical device and predicate medical device is substantiated by the reference device, scientific dental literature and/or from other medical devices commercially available.