(227 days)
No
The summary describes a chemical paste and its intended uses and testing, with no mention of AI or ML technology.
Yes
CleaniCal is used for temporary disinfectant dressings, indirect/direct pulp capping, and managing deep caries lesions, all of which aim to treat or alleviate a medical condition.
No
Explanation: CleaniCal is a calcium hydroxide paste used for therapeutic purposes (disinfectant dressings, pulp capping) in root canals, not for diagnosing conditions.
No
The device description clearly states it is a "pre-filled syringe to Calcium Hydroxide Paste," indicating it is a physical substance and delivery mechanism, not software.
Based on the provided information, CleaniCal is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended uses listed (temporary disinfectant dressings in root canals, indirect/direct pulp capping) are all procedures performed directly on or within the patient's body. IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description of a calcium hydroxide paste in a syringe aligns with a material used for dental procedures within the body, not for testing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, CleaniCal is a medical device used for dental treatment, not an IVD.
N/A
Intended Use / 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 lesions; or
- Direct pulp capping.
Product codes
EJK, KIF
Device Description
CleaniCal is a type of pre-filled syringe to Calcium Hydroxide Paste with a pH 12.3.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
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
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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) |
|---|---|
| ------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------- |
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)
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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
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
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6
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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.