(141 days)
No
The device description and performance studies focus on the physical and chemical properties of a dental filling material, with no mention of AI or ML.
No
The device is a dental filling material used for restoring cavities, not for treating or preventing disease.
No
The device is described as a light-curing dental filling material used for restorative applications (Class I, II, V, III, IV restorations, cervical cavities) and dental surgery treatment, not for diagnosing conditions.
No
The device description clearly states it is a "light curing dental for dental surgery treatment" made in the form of a "paste and filled in syringe," which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for restoring cavities in teeth, which is a dental procedure performed directly on the patient's body.
- Device Description: The device is a light-curing dental filling material used in dental surgery treatment. It is applied directly to the tooth.
- Lack of In Vitro Testing: The description does not mention any testing of samples (like blood, urine, tissue) outside of the body to diagnose a condition or provide information about a patient's health status. The performance studies focus on the physical and chemical properties of the material itself and its biocompatibility, not on analyzing biological samples.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
CharmFil is indicated for following restorative applications.
-
- Class I, II, V restorations of posterior teeth
-
- Class III, IV, V restorations of anterior teeth
-
- Cervical cavities or defects involving root surfaces
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
This device is light curing dental for dental surgery treatment and type 1, class 2, group 1 according to ISO 4049 classification. It is made in the form of paste and filled in syringe. When you use the product, press out the content in the syringe by screw. It is used to restore a cavity as taking out from it as much as you need with an instrument. It is dental filling material for restoring the cavities.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior teeth, anterior teeth, Cervical cavities or defects involving root surfaces
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Physical and chemical property (Polymerization time) / ISO 4049 tests were performed with the following results:
- Color: Suitable (The exposed and unexposed halves of each of the specimens and the unirradiated specimen for any color difference)
- Appearance test: Suitable (Shall be homogeneous and co substances are observed)
- Quantity test: Suitable (No less than ±5% that claimed value)
- Sensitivity to ambient light: Suitable (After exposure for 60sec, it should be not any charge of consistency)
- Polymerization depth: Suitable (After exposure for 1 minute, Opaque shade is more than 1mm, and other shades is over 1.5mm)
- Flexural strength: Suitable (+80 Mpa)
- Water solubility: Suitable (- 40 µg/mm²)
- Water sorption: Suitable (-7.5 µg/mm²)
- Radio-opacity: Suitable (Shall be equal to or greater than that of the same thickness of aluminum and no less than 0.5mm)
- Color stability: Suitable (The exposed and unexposed halves of each of the specimens and the unirradiated specimen for any color difference)
Elution substance test:
- Character test: Suitable (It should be homogeneous and appropriate. Without any foreign substance, impurity, floating substance.)
- pH: Suitable (pH difference ≤ 1.5)
- Heavy metal (Lead content): Suitable (It should be less ticker than comparison liquid. (-100ppm))
- Permanganic acid calcium reduction nature substance: Suitable (Difference of consumption of permanganic acid calcium≤ 2.0 ml)
- Evaporation residue: Suitable (Difference of residues ≤ 1.0 mg)
- Ultraviolet rays absorption spectrum: Suitable (Max. absorbance numerical value ≤ 0.1)
Biological safety test (Biocompatibility, irritation):
- Cell toxicity test: Suitable (0
1 (NoneMild)) - Short period whole body toxicity test (Oral route): Suitable (During the period of examination there should not be odd or dead on it.)
- Oral route impetus test: Suitable (Compare it with contrast product, stimulus response should not appear on mouth mucous)
- Endo-toxin test: Suitable (According to the method of examination, it should be appropriate.)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
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, 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.
May 6, 2020
Dentkist, Inc. % Peter Chung President Plus Global 300 Atwood St. Pittsburgh, Pennsylvania 15213
Re: K193496
Trade/Device Name: CharmFil Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: January 30, 2020 Received: February 6, 2020
Dear Peter Chung:
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
1
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 medical devices and radiation-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,
for Srinivas "Nandu" Nandkumar, Ph.D. 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K193496
Device Name CharmFil
Indications for Use (Describe)
CharmFil is indicated for following restorative applications.
-
- Class I, II, V restorations of posterior teeth
-
- Class III, IV, V restorations of anterior teeth
- Cervical cavities or defects involving root surfaces
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."
3
510(k) Summary
1. Applicant
-
- Company : Dentkisk, Inc
-
- Address : (Dangjeong-dong) 3, Nongshim-ro, Gunpo-si, Gyeonggi-do, Korea
-
- Tel : 82-31-458-2822
-
- Fax : 82-31-458-1312
-
- Prepared date : May. 06, 2020
-
- Contact person : Peter Chung, 412-512-8802
-
- Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA
-
- Submission date : May. 06, 2020
-
- Contact person : J. Y. Lee (jylee@dentkist.com)
2. Device Information
-
- Trade name : CharmFil
-
- Common name : Tooth Shade Resin Material
-
- Classification name : Material, Tooth Shade, Resin
-
- Product code : EBF
-
- Regulation number : 872.3690
-
- Class of device : Class II
-
- Panel : Dental
-
- Model codes : CharmFil Plus, CharmFil Plus Caps, CharmFil Flow
3. The legally marketed device to which we are claiming equivalence
Predicate device : K042124 DenFil, Vericom Co., Ltd. Reference device : K120768 EsFlow, Spident Co., Ltd.
4. Device description
This device is light curing dental for dental surgery treatment and type 1, class 2, group 1 according to ISO 4049 classification. It is made in the form of paste and filled in syringe. When you use the product, press out the content in the syringe by screw. It is used to restore a cavity as taking out from it as much as you need with an instrument. It is dental filling material for restoring the cavities.
5. Indications for Use Statement
CharmFil is indicated for following restorative applications.
-
- Class I, II, V restorations of posterior teeth
-
- Class III, IV, V restorations of anterior teeth
-
- Cervical cavities or defects involving root surfaces
4
6. Predicate device comparison table
1) CharmFil Plus and DenFil Flow
| Manufacturer | Denkist, Inc. | VERICOM Co., Ltd. | Gap
analysis |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| 510(k) No. | K193496 | K042124 | N/A |
| Indications for use
Statement | The CharmFil are intended for class I, II, V of
posterior teeth, class III,IV, V of anterior teeth
and cervical cavities involving root surfaces. | The DenFil are intended for class I, II, V of
posterior teeth, class III,IV, V of anterior teeth
and cervical cavities involving root surfaces. | Same |
| Classification
name | Tooth shade resin material | Tooth shade resin material | Same |
| Trade name | CharmFil Plus, CharmFil Plus Caps | DenFil | N/A |
| Appearance | Image: CharmFil Plus A3, part 1 | Image: DenFil | Similar |
| | Image: CharmFil Plus A3, part 2 | | |
| | Image: CharmFil Plus A3, part 3 | | |
| | Image: CharmFil Plus A3, part 4 | | |
| Product
configuration | Syringe, Disposable tip | Syringe, Disposable tip | Same |
| Expiration date | 2 years | 2 years | Same |
| Standard
conformed | ISO 4049 | | N/A |
| Biocompatibility | Yes | Yes | Same |
| Principle of
operation | Manual | Manual | Same |
2) CharmFil Flow and EsFlow
| Manufacturer | Denkist, Inc. | Spident Co., Ltd. | Gap
analysis |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| 510(k) No. | K193496 | K120768 | N/A |
| Indications for
use Statement | The CharmFil are intended for class I, II, V of
posterior teeth, class III,IV, V of anterior teeth
and cervical cavities involving root surfaces. | The EsFlow are intended for use in
various dental procedures, including
direct anterior and posterior restorations,
blocking out cavity undercuts before
fabrication indirect restorations, and
repair of porcelain / composite materials. | Similar |
| Classification
name | Tooth shade resin material | Tooth shade resin material | Same |
| Trade name | CharmFil Flow | EsFlow | N/A |
| Appearance | Image: CharmFil Flow | Image: EsFlow | Similar |
| Product
configuration | Syringe, Disposable tip | Syringe, Disposable tip | Same |
| Expiration date | 2 years | 2 years | Same |
| Standard
conformed | ISO 4049 | ISO 4049
EN 1641 | N/A |
| Biocompatibility | Yes | Yes | Same |
| Principle of
operation | Manual | Manual | Same |
5
CharmFil Plus and CharmFil Plus Caps contains the same materials with same amount. Only the using method is different because the CharmFil Plus Caps is manufactured capsule-like shape.
The CharmFil has the similar device characteristics as the predicate device, the DenFill and EsFlow; intended use, material, chemical composition, design and use concept are similar.
The differences between CharmFil and the predicate device and reference device has been subjected to performance and product validations testing prior to release. Tests have been performed to ensure the devices comply to applicable industry and US regulations.
An extensive review of literature pertaining to the safety and biocompatibility of CharmFil has been conducted. Appropriate safeguards have been incorporated in the design of CharmFil.
Although some of the materials used are different, the materials for performance are all the other materials meet biocompatibility criteria. The methods of use and physical and chemical performance are similar and all meet the appropriate criteria.
| No. | Test item | Requirements | Result |
|---|---|---|---|
| Physical and chemical property (Polymerization time) / ISO 4049 | |||
| 1 | Color | The exposed and unexposed halves of each of the specimens | |
| and the unirradiated specimen for any color difference | Suitable | ||
| 2 | Appearance test | Shall be homogeneous and co substances are observed | Suitable |
| 3 | Quantity test | No less than ±5% that claimed value | Suitable |
| 4 | Sensitivity to ambient light | After exposure for 60sec, it should be not any charge of | |
| consistency | Suitable | ||
| 5 | Polymerization depth | After exposure for 1 minute, Opaque shade is more than | |
| 1mm, and other shades is over 1.5mm | Suitable | ||
| 6 | Flexural strength | +80 Mpa | Suitable |
| 7 | Water solubility | - 40 µg/mm² | Suitable |
| 8 | Water sorption | -7.5 µg/mm² | Suitable |
| 9 | Radio-opacity | Shall be equal to or greater than that of the same thickness of | |
| aluminum and no less than 0.5mm | Suitable | ||
| 10 | Color stability | The exposed and unexposed halves of | |
| each of the specimens and the | |||
| unirradiated specimen for any color | |||
| difference | Suitable | ||
| Elution substance test | |||
| 11 | Character test | It should be homogeneous and appropriate. Without any | |
| foreign substance, impurity, floating substance. | Suitable | ||
| 12 | pH | pH difference ≤ 1.5 | Suitable |
| 13 | Heavy metal (Lead | ||
| content) | It should be less ticker than comparison liquid. (-100ppm) | Suitable | |
| 14 | Permanganic acid calcium | ||
| reduction nature | |||
| substance | Difference of consumption of permanganic acid calcium≤ 2.0 | ||
| ml | Suitable | ||
| 15 | Evaporation residue | Difference of residues ≤ 1.0 mg | Suitable |
| 16 | Ultraviolet rays absorption | ||
| spectrum | Max. absorbance numerical value | ||
| ≤ 0.1 | Suitable | ||
| Biological safety test (Biocompatibility, irritation) | |||
| 17 | Cell toxicity test | 0 | Suitable |
| 18 | Short period whole body | During the period of examination | Suitable |
7. Performance testing
6
| toxicity test (Oral route) | there should not be odd or dead on it. | ||
|---|---|---|---|
| 19 | Oral route impetus test | Compare it with contrast product, stimulus response should not appear on mouth mucous | Suitable |
| 20 | Endo-toxin test | According to the method of examination, it should be appropriate. | Suitable |
8. Conclusion:
The Device is investigated for function to compare the operation of function between CharmFil and predicate devices.
Comparison results demonstrate that the specifications and performance of the device are same as functional as the legally marketed predicate device.
Therefore, it is concluded that CharmFil is substantially equivalent to the legally marketed predicate device.