CharmFil

K193496 · Dentkist, Inc. · EBF · May 6, 2020 · Dental

Device Facts

• Record ID: K193496
• Device Name: CharmFil
• Applicant: Dentkist, Inc.
• Product Code: EBF · Dental
• Decision Date: May 6, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CharmFil is indicated for following restorative applications. 1. Class I, II, V restorations of posterior teeth 2. Class III, IV, V restorations of anterior teeth 3. Cervical cavities or defects involving root surfaces

Device Story

Light-curing dental resin material; supplied as paste in syringes or capsules. Used by dentists for cavity restoration. Operator manually dispenses material from syringe/capsule using screw mechanism; applies to cavity; light-cures to harden. Provides structural restoration of tooth defects. Benefits include tooth-colored aesthetic repair and functional restoration of posterior/anterior teeth.

Clinical Evidence

Bench testing only. No clinical data. Performance validated via ISO 4049 testing: polymerization time, depth, flexural strength, water solubility/sorption, radio-opacity, and color stability. Biocompatibility confirmed via cell toxicity, short-term systemic toxicity (oral), oral mucosa irritation, and endotoxin testing. All results met specified requirements.

Technological Characteristics

Light-curing tooth shade resin material. Form factor: paste in syringe or capsule. Principle: manual dispensing and light-cured polymerization. Conforms to ISO 4049. Biocompatible materials. No electronic components or software.

Indications for Use

Indicated for patients requiring dental restorations, specifically Class I, II, and V restorations of posterior teeth; Class III, IV, and V restorations of anterior teeth; and treatment of cervical cavities or defects involving root surfaces.

Regulatory Classification

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.

Predicate Devices

• DenFil (K042124)

Reference Devices

• EsFlow (K120768)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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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.

- 1. Class I, II, V restorations of posterior teeth
- 2. Class III, IV, V restorations of anterior teeth

3. 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

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# 510(k) Summary

#### 1. Applicant

- 1) Company : Dentkisk, Inc
- 2) Address : (Dangjeong-dong) 3, Nongshim-ro, Gunpo-si, Gyeonggi-do, Korea
- 3) Tel : [phone]
- 4) Fax : [phone]
- 5) Prepared date : May. 06, 2020
- 5) Contact person : Peter Chung, 412-512-8802
- 6) Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA
- 7) Submission date : May. 06, 2020
- 8) Contact person : J. Y. Lee ([e-mail])

#### 2. Device Information

- 1) Trade name : CharmFil
- 2) Common name : Tooth Shade Resin Material
- 3) Classification name : Material, Tooth Shade, Resin
- 4) Product code : EBF
- 5) Regulation number : 872.3690
- 6) Class of device : Class II
- 7) Panel : Dental
- 8) 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.

- 1. Class I, II, V restorations of posterior teeth
- 2. Class III, IV, V restorations of anterior teeth
- 3. Cervical cavities or defects involving root surfaces

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#### 6. Predicate device comparison table

## 1) CharmFil Plus and DenFil Flow

| Manufacturer | Denkist, Inc. | VERICOM Co., Ltd. | Gap<br>analysis |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| 510(k) No. | K193496 | K042124 | N/A |
| Indications for use<br>Statement | The CharmFil are intended for class I, II, V of<br>posterior teeth, class III,IV, V of anterior teeth<br>and cervical cavities involving root surfaces. | The DenFil are intended for class I, II, V of<br>posterior teeth, class III,IV, V of anterior teeth<br>and cervical cavities involving root surfaces. | Same |
| Classification<br>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<br>configuration | Syringe, Disposable tip | Syringe, Disposable tip | Same |
| Expiration date | 2 years | 2 years | Same |
| Standard<br>conformed | ISO 4049 | | N/A |
| Biocompatibility | Yes | Yes | Same |
| Principle of<br>operation | Manual | Manual | Same |

## 2) CharmFil Flow and EsFlow

| Manufacturer | Denkist, Inc. | Spident Co., Ltd. | Gap<br>analysis |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| 510(k) No. | K193496 | K120768 | N/A |
| Indications for<br>use Statement | The CharmFil are intended for class I, II, V of<br>posterior teeth, class III,IV, V of anterior teeth<br>and cervical cavities involving root surfaces. | The EsFlow are intended for use in<br>various dental procedures, including<br>direct anterior and posterior restorations,<br>blocking out cavity undercuts before<br>fabrication indirect restorations, and<br>repair of porcelain / composite materials. | Similar |
| Classification<br>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<br>configuration | Syringe, Disposable tip | Syringe, Disposable tip | Same |
| Expiration date | 2 years | 2 years | Same |
| Standard<br>conformed | ISO 4049 | ISO 4049<br>EN 1641 | N/A |
| Biocompatibility | Yes | Yes | Same |
| Principle of<br>operation | Manual | Manual | Same |

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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<br>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<br>consistency | Suitable |
| 5 | Polymerization depth | After exposure for 1 minute, Opaque shade is more than<br>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<br>aluminum and no less than 0.5mm | Suitable |
| 10 | Color stability | The exposed and unexposed halves of<br>each of the specimens and the<br>unirradiated specimen for any color<br>difference | Suitable |
| | Elution substance test | | |
| 11 | Character test | It should be homogeneous and appropriate. Without any<br>foreign substance, impurity, floating substance. | Suitable |
| 12 | pH | pH difference ≤ 1.5 | Suitable |
| 13 | Heavy metal (Lead<br>content) | It should be less ticker than comparison liquid. (-100ppm) | Suitable |
| 14 | Permanganic acid calcium<br>reduction nature<br>substance | Difference of consumption of permanganic acid calcium≤ 2.0<br>ml | Suitable |
| 15 | Evaporation residue | Difference of residues ≤ 1.0 mg | Suitable |
| 16 | Ultraviolet rays absorption<br>spectrum | Max. absorbance numerical value<br>≤ 0.1 | Suitable |
| Biological safety test (Biocompatibility, irritation) | | | |
| 17 | Cell toxicity test | 0~1 (None~Mild) | Suitable |
| 18 | Short period whole body | During the period of examination | Suitable |

#### 7. Performance testing

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| | 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.