(114 days)
UltraCal XS calcium hydroxide paste is indicated to be used for:
- temporary dressing for root canals
- apexification and/or perforation
- vital pulpotomy
- direct pulp capping
- indirect pulp capping
- root resorption
- root canal filling for primary teeth
UltraCal XS calcium hydroxide paste is an aqueous, 12.0 to 12.5 pH, radiopaque, premixed paste for direct application.
This document is a 510(k) submission for a medical device called UltraCal XS, a calcium hydroxide paste used in dentistry. It's a "substantial equivalence" determination, not a study proving the device meets specific performance acceptance criteria in the way an AI/ML device would. Therefore, most of the requested information for an AI/ML study (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training sets, etc.) is not applicable here.
However, I can extract and infer some related information regarding the device's technical characteristics and how its equivalence to predicate devices was established.
Here's a breakdown of the applicable information:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in the typical sense of numerical thresholds for clinical performance metrics (e.g., sensitivity, specificity, AUC) that an AI/ML study would define. Instead, it demonstrates "substantial equivalence" to legally marketed predicate devices based on technological characteristics, intended use, and safety. Its performance is implicitly shown through comparison to these predicates and successful completion of verification and validation testing.
| Characteristic / "Acceptance Criteria" (Implicit) | Reported Device Performance (UltraCal XS) | Comparison to Predicate (DiaPaste K210333) |
|---|---|---|
| Product Code | KIF, EJK (Similar to predicates, within accepted codes for this type of device) | Similar |
| Intended Use | •Temporary dressing for root canals•Apexification and/or perforation•Vital Pulpotomy•Direct Pulp Capping•Indirect Pulp Capping•Root resorption•Root canal filling for primary teeth (Within the scope of predicate devices) | Similar: The Indications for Use of the subject device is within that of the predicate and reference device(s). |
| Intended User | Licensed Dentist or Dental Professional | Identical |
| Characteristics (Description) | Aqueous 12.0 to 12.5 pH calcium hydroxide, radiopaque, premixed paste for direct application. | Similar: Subject device and predicates are calcium hydroxide paste with relatively high pH. |
| Composition | -Calcium hydroxide-Water-Barium Sulfate-Propylene Glycol-Hydroxypropyl Methylcellulose | Similar: Primary ingredient (calcium hydroxide) is equivalent. Barium sulfate included as radio-opacifier. Differences in other ingredients (thickeners, humectants, etc.) do not raise new safety/effectiveness questions. |
| Delivery System/Deployment | Product is provided in a 1.2mL syringe with disposable delivery tips. | Similar: Both the subject device and the predicate and reference devices are provided in a pre-filled syringe with or without delivery tips. |
| Physical Properties | -Viscosity-Water Removal-Radio-Opacity (Evaluated through similar testing as predicates, though not directly to ISO 6876 which was deemed not applicable for a temporary dressing as opposed to a sealing material). | Similar: Testing performed to evaluate characteristics of the chemistry. (Note: ISO 6876 applicable for root canal sealing material, not dressing, so direct comparison not made). |
| Calcium Hydroxide Concentration | 35% | Similar: Concentration range is within ranges cleared by FDA and does not raise new questions regarding safety and efficacy. |
| Patient Population | Individuals of all ages and gender and shall be assessed by the administering dental professional. | Identical |
| Biocompatibility and Safety | ISO 7405:2018 (Successfully passed all verification and validation testing, including biocompatibility assessment). | ISO 7405 was applied as it is a recommended biocompatibility evaluation standard for this product type. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission for a dental filling material, not an AI/ML device relying on a "test set" of clinical data to evaluate algorithmic performance. The submission relies on laboratory testing and comparison to existing devices.
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)
Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's safety and effectiveness is established through adherence to recognized standards (e.g., ISO 7405 for biocompatibility) and demonstrated substantial equivalence to legally marketed predicate devices, supported by laboratory characterization of its physical and chemical properties.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
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October 13, 2021
Ultradent Products, Inc. Adam Black Regulatory Affairs Manager 505 West Ultradent Drive (10200 South) South Jordan, Utah 84095
Re: K211905
Trade/Device Name: UltraCal XS Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF, EJK Dated: July 15, 2021 Received: July 16, 2021
Dear Adam Black:
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211905
Device Name UltraCal XS
Indications for Use (Describe)
UltraCal XS calcium hydroxide paste is indicated to be used for:
· temporary dressing for root canals
- apexification and/or perforation
- · vital pulpotomy
- direct pulp capping
- · indirect pulp capping
- · root resorption
- root canal filling for primary teeth
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary-K211905
This summary of the traditional 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92 for UltraCal XS.
l. Applicant's Name and Address
Ultradent Product, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095
| Contact Person: | Mr. Adam Black |
|---|---|
| Title: | Regulatory Affairs Manager |
| Telephone: | 801-553-4425 |
| Cell Phone: | 435-459-9302 |
| Fax: | 801-553-4609 |
Date Summary Prepared: 22 September 2021
II. Name of the Device
| Device: | Resin, Root Canal Filling |
|---|---|
| Trade/Device Name: | UltraCal XS |
| Common Name: | Root Canal Filling Resin |
| Review Panel: | Dental |
| Regulation Number: | 21 CFR 872.3820 |
| Device Class: | Class II |
| Classification Product Code: | KIF |
| Subsequent Product Code: | EJK |
III. Device Description
UltraCal XS calcium hydroxide paste is an aqueous, 12.0 to 12.5 pH, radiopaque, premixed paste for direct application.
IV. Statement of Intended Use
UltraCal XS calcium hydroxide paste is indicated to be used for:
- . Temporary dressing for root canals
- . Apexification and/or perforation
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- Vital Pulpotomy
- Direct Pulp Capping
- Indirect Pulp Capping
- Root resorption
- Root canal filling for primary teeth
V. Predicate Device
UltraCal XS identified primary predicate: DiaPaste (K210333); secondary predicates: CleaniCal (K201799), TheraCal DC (K180344), Dia-Root Bio MTA (K200174).
VII. Comparison of Technological Characteristics
Predicate technological comparison:
The technology, delivery, and intended use of UltraCal XS are substantially equivalent to the identified predicate as outlined in Table 5-1:
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Ultradent Products, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095 Est. Reg. No. 1718912
Table 5-1: UltraCal XS substantial equivalence comparison
| DescriptiveInformation/characteristic | Primary Predicate:DiaPaste (K210333) | Device: UltraCal XS | Secondary Predicate:CleaniCal (K201799) | Secondary Predicate:TheraCal DC (K180344) | Secondary Predicate:Dia-Root Bio MTA(K200174) | Differences |
|---|---|---|---|---|---|---|
| Product Code | KIF | KIF, EJK | EJK, KIF | EJK | KIF | Similar |
| Intended Use | Aqueous ointmentmaterial thattemporarily fills theroot canal for thefollowing indications:-Apexification-Temporary root filling-Root canal filling forprimary teeth-Vital pulpotomy-Temporary pulpcapping | UltraCal XS calciumhydroxide paste isindicated to be usedfor:•Temporary dressingfor root canals•Apexification and/orperforation•Vital Pulpotomy•Direct Pulp Capping•Indirect Pulp Capping•Root resorption•Root canal filling forprimary teeth | CleaniCal is a CalciumHydroxide paste thathas a creamyconsistency and issuitable for severalindications including.-Temporarydisinfectant dressingsin the obturation ofroot canals-Indirect pulp cappingor management ofdeep caries lesions; or-Direct pulp capping | 1. Pulpotomy2. Temporary FillingMaterial3. Repair of RootPerforations4. Repair of FurcationPerforations5. Repair of PerforatingInternal and ExternalResorptions6. Root-End Filling inEndodontic Surgery7. Pulp Exposures (DirectPulp Capping)8. Protective Liner(Indirect Pulp Capping)and Base for Use Undera Variety of Substrates | DIA-ROOT BIO MTA isused for pulp capping(direct pulp capping orpartial pulpotomy) andrepair of root perforation.Other indications for useinclude: repair of rootresorption, root endfilling, apexification andpulpotomy. | SimilarThe Indications for Useof the subject device iswithin that of thepredicate andreference device(s). |
| Intended User | Licensed Dentist orDental Professional | Licensed Dentist orDental Professional | Dental Professional | Dental Professional | Dental Professional | Identical |
| Characteristics | Calcium hydroxidepaste with bariumsulfate, used as a | Aqueous 12.0 to 12.5pH calcium hydroxide,radiopaque, premixed | Pre-filled syringe withcalcium hydroxidepaste with a pH of 12.3. | TheraCal DC is abiocompatible, basic,dual-cured, resin- | SimilarThe subject device aswell as the predicate | |
| DescriptiveInformation/characteristic | Primary Predicate:DiaPaste (K210333) | Device: UltraCal XS | Secondary Predicate:CleaniCal (K201799) | Secondary Predicate:TheraCal DC (K180344) | Secondary Predicate:Dia-Root Bio MTA(K200174) | Differences |
| temporary root canalfilling material. | paste for directapplication. | modified calcium silicateprovided in a pre-filledsyringe | and reference device(s)are both calciumhydroxide paste withrelatively high pH. | |||
| Composition | -Calcium Hydroxide-Titanium Dioxide-Zinc Oxide-Barium Sulfate-Water-Polyether Polyol-Polysorbate(Tween80) | -Calcium hydroxide-Water-Barium Sulfate-Propylene Glycol-HydroxypropylMethylcellulose | -Calcium hydroxide-Zirconium dioxide- Excipients (nMethyl-2-pyrrolidone,Hypromellose) | -Calcium hydroxide-Portland Cement-All other componentsare proprietary | -Calcium silicate-Zirconium dioxide-Citric Acid-Silanamine, 1,1,1-trimethyl-N-(trimethylsilyl-,hydrolysisproducts with silica-Hydroxypropylmethylcellulose | SimilarThe primary ingredientis equivalent in thepredicate and subjectdevice, calciumhydroxide. Bariumsulfate is included inboth as a radio-opacifier. Differences inthe ingredientsincluded varyingchemicals used asthickeners,humectants,emulsifiers, etc.Dia-Root Bio MTA doesnot include calciumhydroxide as acomponent, howeverthe hydration reactionduring setting occursbetween tricalcium |
| DescriptiveInformation/characteristic | Primary Predicate:DiaPaste (K210333) | Device: UltraCal XS | Secondary Predicate:CleaniCal (K201799) | Secondary Predicate:TheraCal DC (K180344) | Secondary Predicate:Dia-Root Bio MTA(K200174) | Differences |
| silicate $(3CaO·SiO2)$ anddicalcium silicate$(2CaO·SiO2)$ to form acalcium hydroxide andcalcium silicate hydrategel, producing analkaline pH. | ||||||
| Delivery Systemor DeploymentMethods | Product is provided ina 2g syringe withdisposable deliverytips | Product is provided ina 1.2mL syringe withdisposable deliverytips | Pre-loaded syringe | Pre-loaded syringe | Powder within a cap &body to be mixed withdistilled water on amixing pad and appliedintraorally with a spatula | SimilarBoth the subject deviceand the predicate andreference devices areprovided in a pre-filledsyringe with or withoutdelivery tips.The difference withDia-Root Bio MTAdelivery is based on thenecessary reaction withwater to achieveperformance. |
| DescriptiveInformation/characteristic | Primary Predicate:DiaPaste (K210333) | Device: UltraCal XS | Secondary Predicate:CleaniCal (K201799) | Secondary Predicate:TheraCal DC (K180344) | Secondary Predicate:Dia-Root Bio MTA(K200174) | Differences |
| PhysicalProperties | Confirmed to ISO 6876-Flowability-Film Thickness-Radio-opacity | -Viscosity-Water Removal-Radio-Opacity | Confirmed to ISO 6876-Packaging-Extraneous matter-Flowability-Radio-opacity | Confirmed to ISO 6876-Radiopaque-Calcium releasing-Basic-Water sorption-Solubility | Confirmed to ISO 6876-Setting time-Solubility-Radiopacity | SimilarISO 6876 is applicablefor root canal sealingmaterial, as UltraCal XSis not intended to sealroot canals and wastherefore deemed notapplicable. Similartesting was performedto evaluate thecharacteristics of thechemistry. |
| CalciumHydroxideConcentration | 22-26% | 35% | 30% | Not specified | Not specified - based onratio of distilled waterand calcium silicate used | SimilarConcentration range iswithin ranges clearedby FDA and does notraise new questionsregarding safety andefficacy. |
| PatientPopulation | Individuals of all agesand gender and shallbe assessed by theadministering dentalprofessional. | Individuals of all agesand gender and shallbe assessed by theadministering dentalprofessional. | Individuals of all agesand gender and shall beassessed by theadministering dentalprofessional. | Not specified | Not specified | Identical |
| DescriptiveInformation/characteristic | Primary Predicate:DiaPaste (K210333) | Device: UltraCal XS | Secondary Predicate:CleaniCal (K201799) | Secondary Predicate:TheraCal DC (K180344) | Secondary Predicate:Dia-Root Bio MTA(K200174) | Differences |
| Biocompatibilityand Safety | ISO 10993 | ISO 7405:2018 | ISO 10993 | ISO 7405:2008ISO 10993-1:2009 | ISO 7405:2018 | ISO 7405 was appliedas it is a recommendedbiocompatibilityevaluation standard forthis product type. |
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VII Conclusion:
The purpose of this submission was to address the change in indications for use of the previously submitted UltraCal XS (K970114). As outlined in the comparison table above, UltraCal XS is similar to the identified predicate device with respect to its intended use, its Intended User, the Device Design, Types of Material used, Delivery System and or Deployment Method, Physical Properties and Patient Population. The subject device also successfully passed all verification and validation testing, including the biocompatibility assessment.
In summary it can be stated that the development of the subject device, UltraCal XS, is based on a well-established technology in the form of the predicate device, DiaPaste (K210333) and is chemically equivalent to the previously submitted UltraCal XS (K970114). The decision to rely on DiaPaste (K210333) as the predicate rather than the previously submitted UltraCal XS (K970114) is due to the updated indications of the subject device. In order to establish substantial equivalence, DiaPaste (K210333) was selected as the best fit predicate based off of chemistry and cleared indications for use.
Based on the completed testing and the comparisons to the predicate device, we believe that UltraCal XS is substantially equivalent to the predicate device and does not raise any different questions regarding safety and effectiveness.
§ 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.