(283 days)
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 pulpectomy, or for apexogenesis 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 points.
Zical Ultra Powder/Liquid is used for permanent obturation of the root canal space with the aid of obturating points.
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.
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.
The document describes the acceptance criteria and performance of several root canal sealers developed by Prevest Denpro Limited. The study involved a series of bench tests conducted according to ISO standards to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Parameter | Acceptance Criteria (ISO Standard & Specific Values) | Reported Device Performance (Summary for all tested sealers) |
|---|---|---|
| Appearance | Pass/Fail (based on acceptable appearance) | All passed |
| Flow | Based on ISO 6876:2012, Section 5.2 | |
| - CalApex, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid | Not less than 17mm | > 17mm |
| - Calplus | 25-28mm | 25-28mm |
| Film Thickness | ISO 6876:2012, Section 5.5, not more than 50µm | <50µm |
| Water Solubility | ISO 6876:2012, Section 5.6, not more than 3% by mass | CalApex: 1.31%, Cerafill RCS: 1.61%, Endoseal: 1.09%, Nanoseal S: 1.06%, Zical Ultra Paste: 1.31%, Zical Ultra Powder/Liquid: 0.75% (All within <3% limit) |
| Working Time | Based on ISO 6876:2012, Section 5.3 | |
| - CalApex | 16-18min | 16-18min |
| - Cerafill RCS, Endoseal, Zical Ultra Paste, Zical Ultra Powder/Liquid | 25-30min | 25-30min |
| - Nanoseal S | 8-10min | 8-10min |
| Setting Time | Based on ISO 6876:2012, Section 5.4 | |
| - CalApex | 20-40min | 20-40min |
| - Cerafill RCS | 24 hours | Within 24 hours |
| - Endoseal, Zical Ultra Paste, Zical Ultra Powder/Liquid | 45-60min | 45-60min |
| - Nanoseal S | 10-15min | 10-15min |
| Disintegration | ISO 6876:2012, Section 4.3.5, no evidence of disintegration | No evidence of disintegration (All passed) |
| Radio-opacity | ISO 13116:2014, above or equal to 3 mm Al | 6 mm Al (All tested sealers, which is above 3mm Al) |
| Biocompatibility | Assessment according to ISO 10993 | Yes (assessment provided for all subject devices) |
| Shelf Life | Same as bench testing pass criteria (ISO 6876:2012) | CalApex: 2 years, Others: 3 years (All met criteria) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the exact sample sizes used for each bench test. It states that the tests were conducted "according to protocols based on ISO 6876:2012 and tested for radio-opacity according to a protocol based on ISO 13116:2014". The data provenance is implied to be from the manufacturer's testing, but no specific country of origin for the data or whether it was retrospective or prospective is mentioned. The manufacturer, Prevest Denpro Limited, is located in India.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This type of information is not applicable to this study. The tests performed are benchtop physical and chemical property evaluations rather than evaluations requiring expert human interpretation of medical images or patient outcomes. The "ground truth" for these tests is defined by the objective measurement protocols and acceptance criteria of the specified ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. The study involves objective bench testing, not subjective assessments requiring adjudication by multiple experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This study focuses on the physical and chemical properties of root canal sealers and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This study does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth for this study is defined by the objective measurement standards and acceptance criteria set forth by international ISO standards (ISO 6876:2012 for most physical properties and ISO 13116:2014 for radio-opacity). For biocompatibility, the ground truth is established by the assessment according to ISO 10993.
8. The sample size for the training set:
Not applicable. This study involves bench testing of medical devices, not training of machine learning models.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this type of device submission.
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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.
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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
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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) | |
|---|---|
| ☑ Prescription Use (Part 21 CER 801 Subpart D) | ☐ Over-The-Counter Use (21 CER 801 Subpart C) |
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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.
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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.
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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:
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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
| CalApexK212563SubjectDevice | SealapexK152959PredicateDevice | ApexitK893794ReferenceDevice | AdsealK042769ReferenceDevice | TheracalK063237ReferenceDevice | MTAFillapexK140247ReferenceDevice | |
|---|---|---|---|---|---|---|
| ProductCode | KIF | KIF | KIF | KIF | EJK | KIF |
| Indicationsfor Use | CalApex is acalciumhydroxide,polymericresin, rootcanal fillingmaterialthat is usedinconjunctionwith guttapercha orsilverendodonticpoints. | Sealapex/SealapexXpress is acalciumhydroxide,polymericresin, rootcanal fillingmaterialthat is usedinconjunctionwith guttapercha orsilverendodonticpoints. | —Permanentobturationfollowingvital pulpextirpation—Permanentobturationfollowingthe removalof agangrenouspulp andplacementof intracanaldisinfectantdressings—Permanentobturationin caseswithexternal andinternalrootresorptionApexit Plusis suitablefor use inthe singlecone andlateralcondensation technique,as well as in | Adseal is abiocompatibleroot canalsealer forpermanentsealing of rootcanalsfollowingestablishedendodonticproceduresand may beused inconjunctionwith theauxiliarymaterials inthe root canal(i.e. guttapercha points)Adseal isintended foruse byqualifiedhealthcarepersonneltrained in itsuse | 1. Liner2. Pulpcappingagent | MTA-Fillapex is aroot canalsealerintendedfor thepermanentscaling ofroot canalsand maybe used incombination with rootcanalobturationmaterials. |
| Device | ||||||
| Description | CalApex is a | Sealapex/SealapexXpress is a | Apexit is an | Adseal rootcanal sealer is | TheraCal is a | MTAFillapex is a |
| non-eugenol,radiopaque,calciumhydroxidepolymericresin rootcanal fillingmaterial.It is a twopart,base/catalyst –paste/pastesystem thatis mixed inequalportions.The mixtureis thencarried tothe rootcanal withendodonticobturationpoints ordirectlydispensedin theroot canaldependingon deliverymethod,e.g. tube ordual-barrelsyringe. | non-eugenol,radiopaque, calciumhydroxidepolymericresin rootcanal fillingmaterial. Itis indicatedfor use as aroot canalsealing andfillingmaterial,and is usedduring anendodonticprocedureto seal offthepreparedroot canalapicalforamenand tubulesfrom blood,exudates,andinfection.Theproposed isa two part,base/catalyst –paste/paste systemthat is | insoluble,radiopaquecalciumhydroxidecement forthepermanentobturationof rootcanals incombinationwith guttaperchapoints. Itdoes notshrinkduringsetting anddemonstrates excellentphysical andbiologicalproperties.Apexit is atwo-componentsystem.Base andactivatorare suppliedin doublepushsyringeswith a staticmixingdevice. | a twocomponentpaste:pastedevice basedupon epoxyamine resinchemistry.This sealer iseasy to mixand adaptsclosely to thewalls of theprepared rootcanal andprovidesoutstandinglong-termdimensionalstability withminimalshrinkageupon setting.The deviceconsists oftowcomponents,the epoxyresin paste(Paste A) andthe aminecontainingpaste (PasteB); portions ofwhich aremixed prior toinsertion intothe root canal.This twocomponent | light-curedresin-based,mineraltrioxideaggregate(MTA) filled,linerdesigned toperform as abarrier andto protectthe dentalpulpalcomplex.TheraCalLC's preciseplacementallows itsuse in alldeep cavitypreparations. The lightcured setpermits thepractitionerimmediateplacementandcondensationof therestorativematerial. Itsproprietaryformulationallows for acommandset with avisible lightcuring unitwhile | mineralttioxideaggregate(MTA) andresin tootcanalsealer usedduringendodontictreatmenttopermanently fill thecanalsystemfollowingdebridement anddisinfection. Itconsists oftwocomponentpastes thatarecombinedin a dualbarrelsyringe forease ofdispensingandconsistentdosage.Beinghydrophilicin nature,MTA | |
| alltechniquesinvolvingheat-softenedgutta-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 | |||
| in the | (i.e. gutta | durable | negatively | |||
| root canal | percha | liner or | affect the | |||
| depending | points). Paste | base. | sealing | |||
| on delivery | A and Paste B | ability and | ||||
| method, | are contained, | is required | ||||
| e.g. tube or | separately, | for proper | ||||
| dual-barrel | within the | setting. It is | ||||
| syringe. | chambers of a | used in | ||||
| two | combinatio | |||||
| component | n ,with | |||||
| plastic | gutta- | |||||
| syringe, | percha or | |||||
| packaged with | silver | |||||
| a disposable | points | |||||
| applicator. | during root | |||||
| canal | ||||||
| obturation. | ||||||
| Compositio | Base | Base | Calcium | Base | Portland | Paste A |
| n | n-ethylene | n-ethylene | salts | Epoxy | cement, | Methyl |
| ortho/para | ortho/para | (hydroxide, | oligomer | polyethylen | Salicylate, | |
| toluene | toluene | oxide, | resin, | e glycol | Butylene | |
| sulfonamid | sulfonamid | phosphate), | ethylene | dimethacryl | Glycol, | |
| e, calcium | e, calcium | hydrogenize | glycol | ate, barium | Colophony, | |
| hydroxide, | hydroxide, | d | salicylate, | zirconate | Calcium | |
| Portland | zinc oxide, | colophony, | bismuth | Tungstate, | ||
| cement, | zinc | disalicylate, | subcarbonate | Fumed | ||
| hydrogenat | stearate | bismuth | Silica | |||
| ed resin, | salts (oxide, | Catalyst | ||||
| zinc oxide, | carbonate), | Polybutanedio | Paste B | |||
| zinc | Catalyst | highly | l, | Fumed | ||
| stearate, | Methyl | dispersed | Aminobenzoat | silica, | ||
| pigment, | salicylate, | silicon | e, | titanium | ||
| inert | isobutyl | dioxide | Calcium | dioxide, | ||
| ingredients | salicylate, | (silanized) | phosphate, | MTA | ||
| 2,2 | (dicalcium |
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{9}------------------------------------------------
| CatalystEthyleneglycolsalicylate,butyleneglycol,tricalciumphosphate,silica, zincoxide,bismuthtrioxide,zincstearate,pigment,inertingredients | dimethylpropane -1,3-diol | and alkylester ofphosphoricacid. | bismuthsubcarbonate | silicate,tricalciumsilicate,calciumoxide,tricalciumaluminate),pentaerythritol,rosinate, p-toluenesulfonamide | ||
|---|---|---|---|---|---|---|
| Form | Two Pastes(Base andCatalyst) | Two Pastes(Base andCatalyst) | Two Pastes(Base andCatalyst) | Two Pastes(Expoxy andAmine) | Light CuredPaste | Two Pastes(Base andCatalyst) |
| Mix Ratio | EqualVolumes | EqualVolumes | EqualVolumes | EqualVolumes | N/A | EqualVolumes |
| FilmThicknessless than50μm limitin ISO 6876 | Yes | Yes | Yes | |||
| Flowaccordingto ISO 6876 | >17mm | 22.8mm | 29mm | |||
| WorkingTime | > 60minutes | > 60minutes | 3 hours | 23 minutes | ||
| SettingTime | < 24 hours | < 24 hours | 130minutes | |||
| WaterSolubility | 1.31% | N/A | 3% | |||
| Radiopacity | 6 mm Al | > 3.3mm Al | > 3mm Al | |||
| Filmthickness,flow, watersolubility,workingtime, anddisintegration meetISO 6876. | Yes | Yes | Yes | Yes |
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| BiocompatibilityAssessmentAccordingto ISO10993 | Yes | Yes | |||
|---|---|---|---|---|---|
| ---------------------------------------------------------------- | ----- | ----- | -- | -- | -- |
| Calplus K212563 | Vitapex K973667 | |
|---|---|---|
| Subject Device | Predicate Device | |
| Product Code | KIF | KIF |
| Indications for Use | Calplus is a temporary orpermanent root canal fillingmaterial for use followingpulpectomy, or forapexogenesis or apexification. | A temporary or permanent rootcanal filling material for use tostimulate the healing processdue to the mixture of calciumhydroxide and iodoform and theinduction effect of these twoingredients. Used to promotehealing effects and to helpprevent bacterial contaminationof the canal, as the twoingredients improve theinduction effect for hard tissueinduction and deposition. To beused as a medicament for thetreatment of infected rootcanals, and as a permanent, lowvolume additive to the fillingprocess of a treated root canalto assist in the induction anddeposition of hard tissue tomake the healing process morerapid and complete. For use inthe treatment of infected rootcanals, or following pulpectomy,or for apexogenesis orapexification, and/or for the tipfilling of prepared, treated rootcanals at the time of final fillingwith gutta-percha. |
| Device Description | Calplus can be used as atemporary or permanent rootcanal filling material. | Vitapex can be used as atemporary or permanent rootcanal filler material. |
| Composition | Iodoform, Calcium hydroxide,Silicone Oil, inert ingredients | Iodoform, Calcium hydroxide,Silicone Oil, inert ingredients |
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| Form | Pre-mixed paste | Pre-mixed |
|---|---|---|
| Flow | 25-28mm | 30mm |
| Film Thickness | <50μm | <50μm |
| Radiopacity | 6 mm Al | >3mm Al |
| Flow and film thickness meetISO 6876 | Yes | Yes |
| Biocompatibility AssessmentAccording to ISO 10993 | Yes | Unknown |
| Product Code | Cerafill RCSK212563Subject Device | Endoseal ΜΤΑK170175Predicate Device | DIA-ROOT BIOsealer K200175Reference Device |
|---|---|---|---|
| KIF | KIF | KIF | KIF |
| Indications forUse | Cerafill RCS is aMTA (mineraltrioxideaggregate) basedroot canal sealerthat providescomplete andpermanentsealing of rootcanals. It can beused with orwithout rootcanal obturationmaterials. | • Permanentobturation of theroot canalfollowing vitalpulp-extirpation •Permanentobturation of theroot canalfollowing removalof infected ornecrotic pulp andplacement ofintracanaldressings. | DIA-ROOT BIOSealer is a MTA(mineral trioxideaggregate) basedroot canal sealerthat providescomplete andpermanentsealing of rootcanals. It can beused with orwithout rootcanal obturationmaterials. |
| DeviceDescription | Cerafill RCS is anendodontic sealerbased on MTA,providing abiocompatibleand effective rootcanal filling. It ispremixed and pre-loaded in asyringe, whichallows a completefilling of theentire root canalincludingaccessory andlateral canals. Theproduct iseugenol-free andwill not impede | ENDOSEAL MTA isan endodonticsealer based onMTA, providing abiocompatibleand effective rootcanal filling. It ispremixed and pre-loaded in asyringe, whichallows a completefilling of theentire root canalincludingaccessory andlateral canals. Theproduct iseugenol-free andwill not impede | DIA-ROOT BIOSealer is ahydraulicmaterial, and apremixed formthat does notrequire mixing. Itblocks the rootcanal byhardening byreacting withwater in the oralcavity. It iscontained in awaterblockedsyringe andcorresponds toISO 6876:2012,Dentistry-Root |
| adhesion insidethe root canal. | adhesion insidethe root canal. | canal sealingmaterials.DIAROOTBIO Sealer hastwo models andthey are packagedwith components;Disposable tip,Silicone cap. | |
| Composition | MTA powder,Zirconium oxide,polyethyleneglycol, propyleneglycol, fumedsilica, bentoniteclay,hydroxypropylmethylcellulose,radiopacifiers | MTA powder(Calcium silicates,Calciumaluminates,Calciumaluminoferrite,Calcium sulfates),Bentonite clay, n-methyl-2pyrrolidone,Hypromellose(alternate namefor hydroxypropylmethylcellulose) | Calcium Silicate- CalciumAluminate- YtterbiumTrifluoride- Zirconium Oxide- Silanamine,1,1,1-trimethyl-N-(trimethylsilyl)-,hydrolysisproducts withsilica (fumedsilica)- HydroxypropylMethylcellulose- Polyethyleneglycol 400- Polyethyleneglycol 200- Sorbitan- White MineralOil- |
| Form | Pre-mixed paste | Pre-mixed paste | |
| Work Time | 25-30 minutes | > 60 minutes | |
| Setting Time | Within 24 hours | < 24 hours | |
| Flow | > 17mm | Not less than 17mm | |
| Film Thickness | <50μm | Not more than50μm | |
| Water Solubility | 1.61% | Not more than 3% | |
| Radiopacity | 6 mm Al | Not less than 3mm Al | |
| Flow, filmthickness, watersolubility, workingtime, setting time | Yes | Yes | Yes |
| and disintegrationmeet ISO 6876 | |||
| BiocompatibilityAssessmentaccording to ISO10993 | Yes | Yes | Yes |
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| Endoseal K212563Subject Device | Pulp Canal Sealer K152956Predicate Device | |
|---|---|---|
| Product Code | KIF | KIF |
| Indications for Use | Endoseal is used for permanentobturation of the root canalspace with the aid of obturatingpoints in accordance with ISO6876 for Dental Root CanalSealing materials. | Pulp Canal Sealer and PulpCanal Sealer EWT are used forpermanent obturation of theroot canal space with the aid ofobturating points in accordancewith ISO 6876 for Dental RootCanal Sealing materials. |
| Device Description | Endoseal is a ZincOxide/Eugenol root canalsealant. The product is made upof two separate components, apowder base and a liquidcatalyst, to form the finaldevice. | They are Zinc Oxide/Eugenolroot canal sealants. Theproducts are made up of twoseparate components, a powderbase and a liquid catalyst, toform the final device. The liquidcatalyst is the same formulationfor both products. PulpCanal Sealer is a fast settingmaterial, while Pulp CanalSealer EWT features anextended work time of greaterthan 6 hours on the pad. |
| Composition | PowderZinc oxide, barium sulfate,magnesium stearate, thymoliodideLiquidEugenolSpearmint Oil | PowderZinc oxide, silver, thymol iodideLiquidEugenolBalsam Canada |
| Form | Powder/Liquid | Powder/Liquid |
| Chemistry of Setting Reaction | Chelation between zinc oxideand eugenol | Chelation between zinc oxideand eugenol |
| Work Time | 25-30 minutes | > 45 minutes |
| Setting Time | 45-60 minutes | < 60 minutes Max |
| Flow | > 17mm | 29mm |
| Film Thickness | <50μm | 22.6 μm |
| Water Solubility | 1.09% | 0.09% |
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| Radiopacity | 6mm Al | Not less than 3mm Al |
|---|---|---|
| Flow, film thickness, watersolubility, working time, settingtime, and disintegration meetISO 6876 | Yes | Yes |
| Biocompatibility Assessmentaccording to ISO 10993 | Yes | Yes |
| Nanoseal S K212563Subject Device | Roeko Seal Root CanalSealer K983037Predicate Device | GuttaSil K190510Reference Device | |
|---|---|---|---|
| Product Code | KIF | KIF | KIF |
| Indications for Use | Nanoseal S is indicatedin patients forpermanentobturations of rootcanal after vitalextirpation or aftertreatment of pulpalgangrene andtemporary filling. | The Roeko Seal Root CanalSealer is indicated inpatients for permanentobturations of root canalafter vital extirpation orafter treatment of pulpalgangrene and temporaryfilling. | GuttaSil is amaterial forpermanentobturation of rootcanals after vitalextirpation andafter treatment ofpulpal gangreneand temporaryfilling of the canal. |
| Device Description | Nanoseal S is apermanent root canalfilling material which issilicone based(polydimethylsiloxane).It is cold flowable andis in a dual barrelcartridge. | Roeko Seal is a permanentroot canal filling material,which is silicone based(polydimethylsiloxane) andconsists additionally ofzircondioxide, paraffin-based oil, silicon oil,hexachloroplatinic acid andsilicic acid. | GuttaSil, aproduct in theform of a pastewhich combinesgutta-percha witha sealer. Thegutta-perchapowder is mixedin a matrix ofpolyvinylsiloxane.It is convenientsince sealing andobturation aresimultaneouslypossible withoutheating and theroot canal can befilled in a quickmanner. Thisdevicecontains a syringe,auto-mix& Endotips, spatula, andmixing pads |
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| Composition | BaseSiloxanes, paraffin oil,silanated silica,zirconium oxide, silver,colorantCatalystSiloxanes, paraffin oil,silanated silica,zirconium oxide,platinum catalyst | Polydimethylpolymethylhydrogen siloxane, siliconeoil, paraffin oil, zirconiumoxide, hexchloropatinic acid | Siloxanes,zirconium dioxide,gutta percha, zincoxide, silver,platinum catalyst,colorant |
|---|---|---|---|
| Form | Two Pastes (Base andCatalyst) | Two Pastes (Base andCatalyst) | |
| Work Time | 8-10 minutes | > 60 minutes | |
| Setting Time | 10-15 minutes | < 24 hours | |
| Flow | >17mm | >17mm | |
| Film Thickness | <50μm | <50μm | |
| Water Solubility | 1.06% | < 3.0% by mass | |
| Radiopacity | 6 mm Al | Not less than 3mm Al | |
| Flow, film thickness,water solubility,working time, settingtime, and disintegrationmeet ISO 6876 | Yes | Yes | Yes |
| BiocompatibilityAssessment accordingto ISO 10993 | Yes | Unknown | Yes |
| Zical Ultra PasteK212563Subject Device | Tubli-Seal K153067Predicate Device | Vitapex K973667Reference Device | |
|---|---|---|---|
| Product Code | KIF | KIF | KIF |
| Indications for Use | Zical Ultra Paste isused for permanentobturation of the rootcanal space with theaid of obturatingpoints. | The Tubli-Seal product line(Tubli-Seal/Tubli-SealXpress/Tubli-SealEWT/Tubli-Seal EWT Xpress)is used forpermanent obturation of theroot canal space with the aidof obturating points. | For use tostimulate thehealing processdue to themixture of calciumhydroxide andiodoform and theinduction effect ofthese twoingredients. Usedto promotehealing effectsand to helpprevent bacterial |
| contamination ofthe canal, as thetwo ingredientsimprove theinduction effectfor hard tissueinduction anddeposition. To beused as amedicament forthe treatment ofinfected rootcanals, and as apermanent, lowvolume additiveto the fillingprocess of atreated root canalto assist in theinduction anddeposition of hardtissue to make thehealing processmore rapid andcomplete. For usein the treatmentof infected rootcanals, orfollowingpulpectomy, orfor apexegenesisor apexification,and/or for the tipfilling of prepared,treated rootcanals at the timeof final filling withgutta-percha. | |||
| Device Description | Zical Ultra Paste is atwo-part,base/accelerator,paste/paste systemthat is mixed in equalportions. The mixtureis carried to the rootcanal with endodonticobturation points. The | It is atwo-part, base/accelerator,paste/paste system that ismixed in equal portions.Then themixture is carried to the rootcanal with endodonticobturation points, or directlydispensed in the root canaldepending on delivery | Vitapex is a pre-mixed calciumhydroxide andiodoform pastewhich is atemporary orpermanent rootcanal fillingmaterial. It comesin a syringe. |
| product comes in adual barrel cartridge. | method, e.g. tube or dual-barrel syringe. The productis available in two (2)working times, Regular andExtended Work Time (EWT)for both delivery options oftubes or dual-barrelsyringes. | ||
| Composition | BaseZinc oxidelodoformBarium sulfateSodium borateBismuth subcarbonateOlive oilCatalystEugenolResinSilicaAcetic acid | BaseZinc oxideBarium sulfateWhite mineral oilCatalystEugenolWhite mineral oil5,5'-diisopropyl-2,2' –dimethyldiphenyl – 4,4'diyldihypoioditeresin | Calcium hydroxidelodoformSilicone oilInert ingredients |
| Form | Two Pastes (Base andCatalyst) | Two Pastes (Base andCatalyst) | |
| Work Time | 8-10 minutes | >60 minutes | |
| Setting Time | 10-15 minutes | 70 minutes | |
| Flow | > 17mm | 29mm | |
| Film Thickness | <50µm | 13.04 µm | |
| Water Solubility | 1.31% | 0.70% | |
| Radiopacity | 6 mm Al | 5 mm Al | |
| Flow, film thickness,water solubility,working time, settingtime, and disintegrationmeet ISO 6876 | Yes | Yes | Yes |
| BiocompatibilityAssessment accordingto ISO 10993 | Yes | Yes | Unknown |
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| Zical Ultra | Tubli-Seal K153067 | Vitapex K973667 | |
|---|---|---|---|
| Powder/Liquid | Predicate Device | Reference Device | |
| K212563 | |||
| Subject Device | |||
| Product Code | KIF | KIF | KIF |
| Indications for Use | Zical UltraPowder/Liquid is used | The Tubli-Seal product line(Tubli-Seal/Tubli-Seal) | For use tostimulate the |
| for permanentobturation of the rootcanal space with theaid of obturatingpoints. | Xpress/Tubli-SealEWT/Tubli-Seal EWT Xpress)is used forpermanent obturation of theroot canal space with the aidof obturating points. | healing processdue to themixture of calciumhydroxide andiodoform and theinduction effect ofthese twoingredients. Usedto promotehealing effectsand to helpprevent bacterialcontamination ofthe canal, as thetwo ingredientsimprove theinduction effectfor hard tissueinduction anddeposition. To beused as amedicament forthe treatment ofinfected rootcanals, and as apermanent, lowvolume additiveto the fillingprocess of atreated root canalto assist in theinduction anddeposition of hardtissue to make thehealing processmore rapid andcomplete. For usein the treatmentof infected rootcanals, orfollowingpulpectomy, orfor apexegenesisor apexification,and/or for the tipfilling of prepared,treated rootcanals at the time | |
| of final filling with | |||
| Device Description | Zical UltraPowder/Liquid is atwo-part,powder/liquid systemfor permanent fillingof root canals. Themixture is carried tothe root canal withendodontic obturationpoints. | It is atwo-part, base/accelerator,paste/paste system that ismixed in equal portions.Then themixture is carried to the rootcanal with endodonticobturation points, or directlydispensed in the root canaldepending on deliverymethod, e.g. tube or dual-barrel syringe. The productis available in two (2)working times, Regular andExtended Work Time (EWT)for both delivery options oftubes or dual-barrelsyringes. | Vitapex is a pre-mixed calciumhydroxide andiodoform pastewhich is atemporary orpermanent rootcanal fillingmaterial. It comesin a syringe. |
| Composition | PowderZinc oxideresinlodoformBarium sulfateBismuth subcarbonateZinc acetateCatalystEugenolOlive oil | BaseZinc oxideBarium sulfateWhite mineral oilCatalystEugenolWhite mineral oil5,5'-diisopropyl-2,2' –dimethyldiphenyl – 4,4'diyldihypoioditeresin | Calcium hydroxidelodoformSilicone oilInert ingredients |
| Form | Powder/liquid | Powder/liquid | |
| Setting Time | 45-60 minutes | 70 minutes | |
| Flow | > 17mm | 29mm | |
| Film Thickness | <50μm | 13.04μm | |
| Water Solubility | 0.75% | 0.70% | |
| Radiopacity | 6 mm Al | 5 mm Al | |
| Flow, film thickness,water solubility,working time, settingtime, and disintegrationmeet ISO 6876 | Yes | Yes | Yes |
| BiocompatibilityAssessment accordingto ISO 10993 | Yes | Yes | Unknown |
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Conclusion: Prevest Denpro Root Canal Sealers are substantially equivalent to the predicate device, Sealapex. They have the same indications, similar testing, and very similar ingredients. The subject devices and predicate or reference devices have similar forms, work, and setting times, flow, film thickness, water solubility, radiopacity. The pass criteria are either the same as the predicate and reference devices (in some cases ISO 6872 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.
Any differences in the measured parameters are minor and do not change the substantial equivalence because all the values meet ISO 6876 or other relevant standard. Both the subject devices and the predicate device have physical parameters which meet requirements of the relevant ISO standards. Both the subject devices and predicate/reference devices have biocompatibility assessments according to ISO 10993. Shelf life testing is similar to the shelf life testing of predicate or reference device. Reference devices are included to cover any ingredients, or indications not covered by the predicate devices. Any differences in ingredients are minor and do not change the substantial equivalence.
§ 872.3820 Root canal filling resin.
(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.