This document describes the premarket notification (510(k)) for CleaniCal, a Calcium Hydroxide Cavity Liner. The information provided is primarily focused on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and comparison of characteristics, rather than a clinical study evaluating diagnostic accuracy or reader performance of an AI-powered device.

Therefore, many of the typical elements used to describe the acceptance criteria and the study proving an AI-powered device meets those criteria are not directly applicable or available in this type of submission. This premarket notification is for a dental material (calcium hydroxide paste), not an AI device.

Let's break down what can be extracted and what cannot, based on the provided text, in the context of your request for an AI device.

Observation: The provided document describes a medical device (a dental calcium hydroxide paste called "CleaniCal"), not an AI-powered device. Therefore, many of the questions related to AI-specific study designs (e.g., MRMC studies, standalone algorithm performance, AI assistance effect size) will not be addressed in this document.

However, I will interpret the request as best as possible using the available information, mapping it to your bullet points where applicable, and highlighting where information is not present for this type of device.

Acceptance Criteria and Device Performance for CleaniCal (a Dental Material)

The acceptance criteria for "CleaniCal" are primarily defined by its ability to meet established ISO standards for dental root canal filling materials and its biocompatibility. The study proving the device meets these criteria is a series of non-clinical (bench and biocompatibility) tests.

1. A table of acceptance criteria and the reported device performance:

The document states: "All the test results met the preset test criteria." The "preset test criteria" are the specific requirements within the referenced ISO standards. The table below summarizes the types of tests performed and the general outcome as stated in the document. Specific numerical acceptance values or reported performance metrics for each test (e.g., exact flow rate, specific radio-opacity value) are not provided in this 510(k) summary, only that the device "met" them.

Acceptance Criterion (Test Type/Standard)	Reported Device Performance
Physical/Chemical Properties:
Visual Assessment	Met preset criteria
Capacity	Met preset criteria
pH	pH 12.3 (Acceptance range not specified, but similar to predicate's pH 12.5)
ISO 6876 - Package	Met preset criteria
ISO 6876 - Extraneous matter	Met preset criteria
ISO 6876 - Flow	Met preset criteria
ISO 6876 - Radio-opacity	Met preset criteria
Biocompatibility (ISO 10993 Series):
ISO 10993-5 Cytotoxicity (Agar diffusion, MTT)	Met preset criteria
ISO 10993-10 - Maximization test for delayed hypersensitivity (LLNA)	Met preset criteria
ISO 10993-11 Acute systemic toxicity	Met preset criteria
ISO 10993-6 Implantation (Subcutaneous tissue)	Met preset criteria
ISO 10993-6 & ISO 10993-11 Subacute systemic toxicity	Met preset criteria
ISO 10993-3 Genotoxicity (Bacterial Reverse Mutation, & Mammalian Erythrocyte Micronucleus)	Met preset criteria

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not explicitly stated in the document. For non-clinical bench testing, sample sizes are typically determined by relevant ISO standards or internal quality procedures.
Data Provenance: The testing institution is MARUCHI itself (the manufacturer) or external labs contracted by MARUCHI, as implied by "Testing institution's method." The country of origin for the testing would likely be Republic of Korea as that is where MARUCHI is located. These are non-clinical, pre-market tests, so the retrospective/prospective distinction for clinical data doesn't apply here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. For this type of dental material, "ground truth" is established by adherence to specified physical, chemical, and biological properties as defined by international standards (e.g., ISO 6876, ISO 10993). This does not involve clinical "experts" in the sense of radiologists reading images to establish ground truth for diagnostic AI. The tests are laboratory-based measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic accuracy assessments where human readers interpret data that AI might also interpret. The tests performed for CleaniCal are objective laboratory measurements, not subjective evaluations requiring adjudication.

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 is not an AI-powered device. Therefore, no MRMC study, AI assistance comparison, or effect size calculation with human readers was performed or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is not an AI-powered device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For CleaniCal, the "ground truth" is based on objective measurements of material properties and biological responses as defined by international standards (ISO 6876, ISO 10993 series). This includes properties like pH, flow, radio-opacity, and results of various biocompatibility tests (cytotoxicity, systemic toxicity, genotoxicity, implantation). It is not clinical ground truth derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

Not Applicable. This is not an AI-powered device. There is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

Not Applicable. This is not an AI-powered device. There is no "training set" or "ground truth establishment" for a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 12, 2021

Maruchi Jang Wook CEO 2-208, Medical Industry Complex Bldg., 42-10, Taejanggongdan Wonju-si, Gangwon-do 26311 REPUBLIC OF KOREA

Re: K201799

Trade/Device Name: CleaniCal Regulation Number: 21 CFR 872.3250 Regulation Name: Calcium Hydroxide Cavity Liner Regulatory Class: Class II Product Code: EJK, KIF Dated: December 28, 2020 Received: January 6, 2021

Dear Jang Wook:

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 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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4. INDICATION FOR USE STATEMENT

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)	K201799
Device Name	CleaniCal

Indications for Use (Describe)

CleaniCal is a Calcium Hydroxide paste that has a creamy consistency and is suitable for several indications including:

Temporary disinfectant dressings in the obturation of root canals;
Indirect pulp capping or management of deep caries lesions; or
Direct pulp capping.

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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5. 510(k) SUMMARY

510(k) Summary

Date: June 15, 2020

1. SUBMITTER

MARUCHI
2-208, Medical Industry Complex Bldg., 42-10, Taejanggongdan-gil, Wonju-si, Gangwon-do, 26311, Republic of Korea TEL : +82-33-734-0330 FAX : +82-33-746-2804 Contact Name: Sung Wook, Jang Email: ecometal@endocem.com

2. DEVICE

·Trade Name: CleaniCal
·Common Name: Calcium hydroxide paste
· Classification Name: Liner, Cavity, Calcium hydroxide
· Regulation Number 872.3250

·Class: 2

·Classification Product Code: EJK

·Subsequent Product Code: KIF

3. Predicate Device

K060365, APEXCAL, Ivoclar Vivadent K170175, ENDOSEAL MTA, MARUCHI

4. DEVICE DESCRIPTION

CleaniCal is a type of pre-filled syringe to Calcium Hydroxide Paste with a pH 12.3.

5. INDICATIONS FOR USE

CleaniCal is a Calcium Hydroxide paste that has a creamy consistency and is suitable

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for several indications including:

- Temporary disinfectant dressings in the obturation of root canals;
- Indirect pulp capping or management of deep caries lesions; or
- Direct pulp capping.

6. PERFORMANCE TESTING (NON-CLINICAL)

The following test articles were tested based on the referenced standard. All the test results met the preset test criteria.

Testing institution's method Visual, Capacity, pH .
. ISO 6876 - Package, Extraneous matter, Flow and Radio-opacity
ISO 10993-5 Cytotoxicity (Agar diffusion, MTT) •
. ISO 10993-10 - Maximization test for delayed hypersensitivity (LLNA)
ISO 10993-11 Acute systemic toxicity •
ISO 10993-6 Implantation (Subcutaneous tissue) •
ISO 10993-6 & ISO 10993-11 Subacute systemic toxicity, .
ISO 10993-3 Genotoxicity (Bacterial Reverse Mutation, & Mammalian . Erythrocyte Micronucleus)

	Proposed Device	Predicate Device	Reference Device	Discuss/Justifythe Differences
510(k) Number	New	K060365	K170175	-
Trade Name	CleaniCal	APEXCAL	ENDOSEAL MTA	-
Manufacturer	MARUCHI	IVOCLARVIVADENT, INC.	MARUCHI	-
Common Name	Calciumhydroxide paste	Calciumhydroxide paste	RootMaterial	Filling Equivalent
ClassificationName	Liner, Cavity,Calciumhydroxide	Liner, Cavity,Calciumhydroxide	Resin, Root canalfilling	Equivalent
Device Class	2	2	2	Equivalent
Product Code	EJK	EJK	KIF	Equivalent
DeviceDescription	CleaniCal is a type ofpre-filledsyringe to CalciumHydroxide Pastewith a pH 12.3.	ApexCal is acreamy,radiopaque, ready-to-use calciumhydroxide pastewith a pH above12.5.	ENDOSEAL MTAis an endodonticsealer based onMTA, providing aroot canal filling. Itis premixed and pre-loaded in a syringe,which allowsa complete filling ofthe entire root canalincluding accessoryand lateral canals.	Equivalent
Indicationsfor Use	CleaniCal is aCalciumHydroxide pastethat has a creamyconsistency and issuitable for severalindicationsincluding:* Temporarydisinfectantdressings in theobturation of rootcanals;* Indirect pulpcapping ormanagement ofdeep caries	ApexCAL is aCalciumHydroxide pastethat has a creamyconsistency and issuitable for severalindicationsincluding:* Temporarydisinfectantdressings in theobturation of rootcanals;* Indirect pulpcapping ormanagement ofdeep caries	* Permanentobturation of theroot canal followingvital pulp-extirpation* Permanentobturation of theroot canal followingremoval of infectedor necrotic pulp andthe placement ofintracanal dressings.	Equivalent
	lesions; or* Direct pulp capping.	lesions; or* Direct pulp capping.
Intended user	Dental professional	Dental professional	Dental professional	Equivalent
Standards	ISO 6876	ISO 6876	ISO 6876	Equivalent
ChemicalComposition	-Calciumhydroxide-Zirconiumdioxide- Excipients (n-Methyl-2-pyrrolidone,Hypromellose)	- Calciumhydroxide- Bismuthcarbonate- Excipients(polyethyleneglycol, glycerine,water)	-Natural PureCement-Zirconium dioxide-Bismuth trioxide- Excipients(Bentonite Clay, Methyl-2-Pyrrolidone,Hypromellose)	The maincomponent issame, but someothercomponents aredifferent.However, thebiocompatibilityand theperformancetest resultssupported thatthe subjectdevice issubstantiallyequivalent to thepredicatedevices.
Content ofcalciumhydroxide	30 %	29 %		Equivalent
pH	12.3	12.5		Equivalent
Liquid Formula	Paste type	Paste type	Paste type	Equivalent
Packaging	Pre-loaded syringe	Pre-loaded syringe	Pre-loaded syringe	Equivalent
Sterile	Non-sterile	Non-sterile	Non-sterile	Equivalent
Shelf Life	2 years	2 years	2 years	Equivalent

7. SUBSTANITAL EQUIVALENCE

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8. SUBSTANTIAL EQUIVALENCE DISCUSSION

CleaniCal has the same indications for use and the principle of operations as the predicate devices. It is intended purpose as they are placed into the root canal as a calcium hydroxide paste which met the requirement according to ISO 6876. It has similar physical and biocompatible properties and demonstrates comparable performance specifications to the predicate devices.

The chemical compositions might slightly different from the predicate devices, both are used calcium hydroxide main composition as medicament, and additional component is used to make its appropriate workability.

The bench and biocompatibility testing performed demonstrates that any differences in their technological characteristics do not raise any new questions as to safety and effectiveness. Therefore, it is concluded that CleaniCal is substantially equivalent to the predicate devices. Hence, its equivalent is acceptable because it shows no clinically significant difference in the performance and safety to the device.

Regulation Number and Section

§ 872.3250 Calcium hydroxide cavity liner.

(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.