CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid

{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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below. May 23, 2022 Prevest Denpro Limited % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030-0172 Re: K212563 Trade/Device Name: CalApex, Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: February 15, 2022 Received: February 28, 2022 Dear Angela Blackwell: 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. {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 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. 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K212563 #### Device Name Prevest Denpro Root Canal Sealers - Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/ Liquid #### Indications for Use (Describe) CalApex is a calcium hydroxide, polymeric resin, root canal filling material that is used in conjunction with gutta percha or silver endodontic points. Calplus is a temporary or permanent root canal filling material for use following pulpectorny, or for apexogenesss or apexification. Cerafill RCS is a MTA (mineral trioxide aggregate) based root canal sealer that provides complete and permanent sealing of root canals. It can be used with or without root canal obturation materials. Endoseal is used for permanent obturation of the root canal space with the aid of obturating points in accordance with ISO 6876 for Dental Root Canal Sealing materials. Nanoseal S is indicated in patients for permanent obturations of root canal after vital extirpation or after treatment of pulpal gangrene and temporary filling. Zical Ultra Paste is used for permanent obturation of the root canal space with the aid of obturating pounts. Zical Ultra Powder/Liquid is used for permanent obturation of the root canal space with the aid of obturating points. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CER 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CER 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}------------------------------------------------ # Prevest DenPro Root Canal Sealers (Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid) 510K Summary K212563 May 18, 2022 Name and Address: Prevest Denpro Limited Export Promotion Industrial Park Bari Brahmana, Jammu 181133 India Contact Person: Atul Modi Email: prevestindia@gmail.com Telephone: (941) 919 4280 Name of device: Prevest Denpro Root Canal Sealers (CalApex, Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid) Classification Name: root canal sealer CFR: 21 CFR 872.3820 Primary Product Code: KIF ## Submission Contact: Angela Blackwell Blackwell Device Consulting P.O. Box 718 Gresham, OR 97030-0172 (704)450-9934 angela@blackwelldevice.com ## Device Description: CalApex is a non-eugenol, radiopaque, calcium hydroxide polymeric resin root canal filling material. It is a two part, base/catalyst – paste/paste system that is mixed in equal portions. The mixture is then carried to the root canal with endodontic obturation points or directly dispensed in the root canal depending on delivery method, e.g. tube or dual-barrel syringe. Calplus can be used as a temporary or permanent root canal filling material. Cerafill RCS is an endodontic sealer based on MTA, providing a biocompatible and effective root canal filling. It is premixed and pre-loaded in a syringe, which allows a complete filling of the entire root canal including accessory and lateral canals. The product is eugenol-free and will not impede adhesion inside the root canal. Endoseal is a Zinc Oxide/Eugenol root canal sealant. The product is made up of two separate components, a powder base and a liquid catalyst, to form the final device. {4}------------------------------------------------ Nanoseal S is a permanent root canal filling material which is silicone based (polydimethylsiloxane). It is cold flowable and is in a dual barrel cartridge. Zical Ultra Paste is a two-part, base/accelerator, paste/paste system that is mixed in equal portions. The mixture is carried to the root canal with endodontic obturation points. The product comes in a dual barrel cartridge. Zical Ultra Powder/Liquid is a two-part, powder/liquid system for permanent filling of root canals. The mixture is carried to the root canal with endodontic obturation points. | Device Name | Indications | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | CalApex | CalApex is a calcium hydroxide, polymeric resin, root canal filling material that is used in conjunction with gutta percha or silver endodontic points. | | Calplus | Calplus is a temporary or permanent root canal filling material for use following pulpectomy, or for apexogenesis or apexification. | | Cerafill RCS | Cerafill RCS is a MTA (mineral trioxide aggregate) based root canal sealer that provides complete and permanent sealing of root canals. It can be used with or without root canal obturation materials. | | Endoseal | Endoseal is used for permanent obturation of the root canal space with the aid of obturating points in accordance with ISO 6876 for Dental Root Canal Sealing materials. | | Nanoseal S | Nanoseal S is indicated in patients for permanent obturations of root canal after vital extirpation or after treatment of pulpal gangrene and temporary filling. | | Zical Ultra Paste | Zical Ultra Paste is used for permanent obturation of the root canal space with the aid of obturating points. | | Zical Ultra Powder/Liquid | Zical Ultra Powder/Liquid is used for permanent obturation of the root canal space with the aid of obturating points. | ## Indications for Use: ## Testing Summary: CalApex, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, and Zical Ultra (powder/liquid) were tested for appearance, flow, film thickness, water solubility, working time, and disintegration according to protocols based on ISO 6876:2012 and tested for radio-opacity according to a protocol based on ISO 13116:2014. CalPlus was tested for appearance, flow and film thickness according to ISO 6876:2012, and radio-opacity according to ISO 13116: 2014. {5}------------------------------------------------ Appearance uses a pass/fail criteria set for each device based on the acceptable appearance of each paste, base or catalyst. Flow test method is based on Section 5.2 of ISO 6876:2012. The CalApex, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, and Zical Ultra (powder/liquid) pass criteria is not less than 17mm. The CalPlus pass criteria is 25-28mm. Film thickness is based on Section 5.5 of ISO 6876:2012. The pass criteria for all subject root canal sealers is not more than 50µm. Water solubility is based on Section 5.6 of ISO 6876:2012. The pass criteria for all subject root canal sealers is shall not be more than 3% by mass. Working time is based on Section 5.3 of ISO 6876:2012. The CalAPex pass criteria is 16-18min. The Cerafill RCS, Endoseal, Zical Ultra Paste, and Zical Ultra (powder/liquid) pass criteria is 25-30min. The Nanoseal S pass criteria is 8-10min. Setting time is based on Section 5.4 of ISO 6876:2012. The CalApex pass criteria is 20-40min. The Cerafill RCS pass criteria is 24 hours. The Endoseal, Zical Ultra Paste, and Zical Ultra (powder/liquid) pass criteria is 45-60min. The Nanoseal S pass criteria is 10-15min. Disintegration is based on Section 4.3.5 of ISO 6876:2012. The pass criteria for all subject root canal sealers is no evidence of disintegration. Radio-opacity is based on ISO 13116:2014. The pass criteria for all subject root canal sealers is above or equal to 3 mm when compared with aluminum wedge. All test results passed and the test method pass criteria in standards. All test reports are included. The bench testing is the same type of test done by the predicate and reference devices. The pass criteria are either the same as the predicate and reference devices (in some cases ISO 6876 sets pass criteria for all root canal sealers) or the pass criteria are tighter than those of the predicate and reference devices. Having a tighter pass criteria would not change the substantial equivalence because the subject devices would also still meet the pass criteria used by the predicate and reference devices. Shelf life for the root canal sealers is 3 years except for CalApex which is 2 years. Shelf life uses the same testing protocols as the characterization testing which are based on ISO 6876:2012. Pass criteria are the same as for bench testing. The predicate and reference devices use the same ISO standard for their testing but have unknown shelf lives in most cases (Sealapex and MTA Fillapex have a 2 year shelf life). A biocompatibility assessment according to ISO 10993 was provided for all subject devices. Predicate Devices: Sealapex K152959, Vitapex K973667, Endoseal MTA K170175, Pulp Canal Sealer K152956, Roeko Seal Root Canal Sealer K983037, Tubliseal K153067 Reference Devices: Apexit K893794 (ingredients), Adseal K042769 (ingedients), Theracal K063237 (ingredients), MTA Fillapex K140247 (ingredients), Dia-Root Bio K200175 (ingredients), GuttaSil K190510 (ingredients) ## Substantial Equivalence: {6}------------------------------------------------ The root canal sealers have similar ingredients to the predicate and reference devices, the same indications for use, and similar physical parameter testing. Root Canal Sealers from Prevest Denpro | | CalApex<br>K212563<br>Subject<br>Device | Sealapex<br>K152959<br>Predicate<br>Device | Apexit<br>K893794<br>Reference<br>Device | Adseal<br>K042769<br>Reference<br>Device | Theracal<br>K063237<br>Reference<br>Device | MTA<br>Fillapex<br>K140247<br>Reference<br>Device | |--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product<br>Code | KIF | KIF | KIF | KIF | EJK | KIF | | Indications<br>for Use | CalApex is a<br>calcium<br>hydroxide,<br>polymeric<br>resin, root<br>canal filling<br>material<br>that is used<br>in<br>conjunction<br>with gutta<br>percha or<br>silver<br>endodontic<br>points. | Sealapex/<br>Sealapex<br>Xpress is a<br>calcium<br>hydroxide,<br>polymeric<br>resin, root<br>canal filling<br>material<br>that is used<br>in<br>conjunction<br>with gutta<br>percha or<br>silver<br>endodontic<br>points. | —<br>Permanent<br>obturation<br>following<br>vital pulp<br>extirpation<br>—<br>Permanent<br>obturation<br>following<br>the removal<br>of a<br>gangrenous<br>pulp and<br>placement<br>of intracanal<br>disinfectant<br>dressings<br>—<br>Permanent<br>obturation<br>in cases<br>with<br>external and<br>internal<br>root<br>resorption<br>Apexit Plus<br>is suitable<br>for use in<br>the single<br>cone and<br>lateral<br>condensatio<br>n technique,<br>as well as in | Adseal is a<br>biocompatible<br>root canal<br>sealer for<br>permanent<br>sealing of root<br>canals<br>following<br>established<br>endodontic<br>procedures<br>and may be<br>used in<br>conjunction<br>with the<br>auxiliary<br>materials in<br>the root canal<br>(i.e. gutta<br>percha points)<br>Adseal is<br>intended for<br>use by<br>qualified<br>healthcare<br>personnel<br>trained in its<br>use | 1. Liner<br>2. Pulp<br>capping<br>agent | MTA-<br>Fillapex is a<br>root canal<br>sealer<br>intended<br>for the<br>permanent<br>scaling of<br>root canals<br>and may<br>be used in<br>combinatio<br>n with root<br>canal<br>obturation<br>materials. | | Device | | | | | | | | Description | CalApex is a | Sealapex/S<br>ealapex<br>Xpress is a | Apexit is an | Adseal root<br>canal sealer is | TheraCal is a | MTA<br>Fillapex is a | | | non-<br>eugenol,<br>radiopaque,<br>calcium<br>hydroxide<br>polymeric<br>resin root<br>canal filling<br>material.<br>It is a two<br>part,<br>base/catalyst –<br>paste/paste<br>system that<br>is mixed in<br>equal<br>portions.<br>The mixture<br>is then<br>carried to<br>the root<br>canal with<br>endodontic<br>obturation<br>points or<br>directly<br>dispensed<br>in the<br>root canal<br>depending<br>on delivery<br>method,<br>e.g. tube or<br>dual-barrel<br>syringe. | non-<br>eugenol,<br>radiopaque<br>, calcium<br>hydroxide<br>polymeric<br>resin root<br>canal filling<br>material. It<br>is indicated<br>for use as a<br>root canal<br>sealing and<br>filling<br>material,<br>and is used<br>during an<br>endodontic<br>procedure<br>to seal off<br>the<br>prepared<br>root canal<br>apical<br>foramen<br>and tubules<br>from blood,<br>exudates,<br>and<br>infection.<br>The<br>proposed is<br>a two part,<br>base/catalyst –<br>paste/paste system<br>that is | insoluble,<br>radiopaque<br>calcium<br>hydroxide<br>cement for<br>the<br>permanent<br>obturation<br>of root<br>canals in<br>combination<br>with guttapercha<br>points. It<br>does not<br>shrink<br>during<br>setting and<br>demonstrates excellent<br>physical and<br>biological<br>properties.<br>Apexit is a<br>two-<br>component<br>system.<br>Base and<br>activator<br>are supplied<br>in doublepush<br>syringes<br>with a static<br>mixing<br>device.<br> | a two<br>component<br>paste:paste<br>device based<br>upon epoxyamine resin<br>chemistry.<br>This sealer is<br>easy to mix<br>and adapts<br>closely to the<br>walls of the<br>prepared root<br>canal and<br>provides<br>outstanding<br>long-term<br>dimensional<br>stability with<br>minimal<br>shrinkage<br>upon setting.<br>The device<br>consists of<br>tow<br>components,<br>the epoxy<br>resin paste<br>(Paste A) and<br>the amine<br>containing<br>paste (Paste<br>B); portions of<br>which are<br>mixed prior to<br>insertion into<br>the root canal.<br>This two<br>component | light-cured<br>resin-based,<br>mineral<br>trioxide<br>aggregate<br>(MTA) filled,<br>liner<br>designed to<br>perform as a<br>barrier and<br>to protect<br>the dental<br>pulpal<br>complex.<br>TheraCal<br>LC's precise<br>placement<br>allows its<br>use in all<br>deep cavity<br>preparations. The lightcured set<br>permits the<br>practitioner<br>immediate<br>placement<br>and<br>condensation<br>of the<br>restorative<br>material. Its<br>proprietary<br>formulation<br>allows for a<br>command<br>set with a<br>visible light<br>curing unit<br>while | mineral<br>ttioxide<br>aggregate<br>(MTA) and<br>resin toot<br>canal<br>sealer used<br>during<br>endodontic<br>treatment<br>to<br>permanently fill the<br>canal<br>system<br>following<br>debridement and<br>disinfection. It<br>consists of<br>two<br>component<br>pastes that<br>are<br>combined<br>in a dual<br>barrel<br>syringe for<br>ease of<br>dispensing<br>and<br>consistent<br>dosage.<br>Being<br>hydrophilic<br>in nature,<br>MTA | | all<br>techniques<br>involving<br>heat-<br>softened<br>gutta-<br>percha. | | | | | | | | | | mixed in | | system reacts | maintaining | FILLAPEX is | | | | equal | | via an | ease of | desirable | | | | portions. | | epoxide- | placement | as a root | | | | Then, the | | amine | due to | filling | | | | mixture | | chemical | thixotropic | material | | | | is carried to | | reaction to | properties. | because an | | | | the root | | cause setting. | The | isolated | | | | canal with | | It may be used | proprietary | dry field is | | | | endodontic | | in conjunction | hydrophilic | not | | | | obturation | | with the | resin | necessary | | | | points or | | auxiliary | formulation | for use. | | | | directly | | materials in | creates a | Moisture | | | | dispensed | | the root canal | stable and | does not | | |…