Who is the manufacturer of CleaniCal?

Maruchi filed the 510(k) submission for CleaniCal (K201799).

What is the FDA product code for CleaniCal?

EJK. It is classified under 21 CFR 872.3250 as a Class 2 device in the Dental panel.

What is the regulatory pathway for CleaniCal?

510(k) clearance (submission type: Traditional).

What are the predicate devices for CleaniCal?

APEXCAL (K060365); ENDOSEAL MTA (K170175).

Who can help prepare an FDA 510(k) submission like CleaniCal?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CleaniCal

K201799 · Maruchi · EJK · Feb 12, 2021 · Dental

Device Facts

Record ID	K201799
Device Name	CleaniCal
Applicant	Maruchi
Product Code	EJK · Dental
Decision Date	Feb 12, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3250
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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.

Device Story

CleaniCal is a pre-filled syringe containing calcium hydroxide paste (pH 12.3). Used by dental professionals in clinical settings for endodontic and restorative procedures. The paste is applied directly into root canals or onto exposed/deep pulp tissue to act as a disinfectant dressing or capping agent. The high pH environment provides antimicrobial properties. The device is supplied non-sterile and is intended for professional use to manage caries and facilitate root canal therapy.

Clinical Evidence

Bench testing only. Testing included visual inspection, capacity, pH, flow, and radio-opacity per ISO 6876. Biocompatibility testing included ISO 10993-5 (cytotoxicity), ISO 10993-10 (delayed hypersensitivity), ISO 10993-11 (acute/subacute systemic toxicity), ISO 10993-6 (implantation), and ISO 10993-3 (genotoxicity). All results met preset criteria.

Technological Characteristics

Calcium hydroxide paste (30% concentration, pH 12.3). Composition includes zirconium dioxide, n-Methyl-2-pyrrolidone, and hypromellose. Form factor is a pre-filled syringe. Non-sterile. Shelf life of 2 years. Testing performed per ISO 6876.

Indications for Use

Indicated for dental professionals performing temporary disinfectant dressings in root canal obturation, indirect pulp capping, management of deep caries lesions, or direct pulp capping.

Regulatory Classification

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.

Predicate Devices

APEXCAL (K060365)
ENDOSEAL MTA (K170175)

Related Devices

K060365 — APEXCAL · Ivoclar Vivadent, Inc. · Apr 17, 2006
K211905 — UltraCal XS · Ultradent Products, Inc. · Oct 13, 2021
K120003 — NUCAL · Pulpdent Corporation · Apr 5, 2012
K032361 — ENDOPURE ROOT CANAL CLEANSER · Dentsply Intl. · Jan 12, 2004
K022734 — PULPDENT CALCIUM HYDROXIDE PREPARATION · Pulpdent Corporation · Oct 7, 2002

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ #### 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) | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | |-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| |-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| 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." FORM FDA 3881 (7/17) {3}------------------------------------------------ ## 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 {4}------------------------------------------------ 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/Justify the Differences | |------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | New | K060365 | K170175 | - | | Trade Name | CleaniCal | APEXCAL | ENDOSEAL MTA | - | | Manufacturer | MARUCHI | IVOCLAR VIVADENT, INC. | MARUCHI | - | | Common Name | Calcium hydroxide paste | Calcium hydroxide paste | Root Material | Filling Equivalent | | Classification Name | Liner, Cavity, Calcium hydroxide | Liner, Cavity, Calcium hydroxide | Resin, Root canal filling | Equivalent | | Device Class | 2 | 2 | 2 | Equivalent | | Product Code | EJK | EJK | KIF | Equivalent | | Device Description | CleaniCal is a type of pre-filled syringe to Calcium Hydroxide Paste with a pH 12.3. | ApexCal is a creamy, radiopaque, ready- to-use calcium hydroxide paste with a pH above 12.5. | ENDOSEAL MTA is an endodontic sealer based on MTA, providing a 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. | Equivalent | | Indications for Use | 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 | ApexCAL 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 | * Permanent obturation of the root canal following vital pulp- extirpation * Permanent obturation of the root canal following removal of infected or necrotic pulp and the placement of intracanal 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 | | Chemical Composition | -Calcium hydroxide -Zirconium dioxide - Excipients (n- Methyl-2- pyrrolidone, Hypromellose) | - Calcium hydroxide - Bismuth carbonate - Excipients (polyethylene glycol, glycerine, water) | -Natural Pure Cement -Zirconium dioxide -Bismuth trioxide - Excipients (Bentonite Clay, Methyl-2- Pyrrolidone, Hypromellose) | The main component is same, but some other components are different. However, the biocompatibility and the performance test results supported that the subject device is substantially equivalent to the predicate devices. | | Content of calcium hydroxide | 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 {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ ## 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.