Well-Root ST

K170950 · Vericom Co., Ltd. · KIF · Dec 20, 2017 · Dental

Device Facts

• Record ID: K170950
• Device Name: Well-Root ST
• Applicant: Vericom Co., Ltd.
• Product Code: KIF · Dental
• Decision Date: Dec 20, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Permanent sealing of root canal

Device Story

Well-Root ST is a premixed, ready-to-use, injectable hydraulic cement paste used for permanent root canal filling and sealing. The device is supplied in a pre-loaded plastic syringe with disposable tips and a holder. It functions as an insoluble, radiopaque material that sets and hardens upon exposure to moisture (hydration reaction) within the root canal. It is intended for use by dental professionals in a clinical setting. The clinician injects the paste into the root canal to provide a permanent seal. The device benefits patients by facilitating effective root canal obturation, preventing leakage, and supporting endodontic treatment success.

Clinical Evidence

Bench testing only. Performance testing included ISO 6876 compliance (flow, setting time, film thickness, solubility, disintegration, radio-opacity, working time) and shelf-life stability. Biocompatibility testing followed ISO 10993 standards, including cytotoxicity (ISO 10993-5), sensitivity (ISO 10993-10), acute systemic toxicity (ISO 10993-11), genotoxicity (ISO 10993-3), and implantation (ISO 10993-6). Results demonstrate the device meets performance requirements and is biocompatible.

Technological Characteristics

Premixed, ready-to-use injectable hydraulic cement paste. Composition: calcium aluminosilicate compound, zirconium oxide (radiopaque agent), calcium sulfate dihydrate, titanium dioxide, inorganic glass (calcium sodium phosphosilicate), and lubricants. Form factor: pre-loaded syringe with disposable tips. Setting mechanism: moisture-activated hydration reaction. Conforms to ISO 6876. Supplied non-sterile.

Indications for Use

Indicated for permanent sealing of root canals in patients requiring endodontic procedures.

Regulatory Classification

Identification

A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.

Predicate Devices

• AH PLUS ROOT CANAL SEALER (K960548)

Reference Devices

• iRoot SP (K080917)

Submission Summary (Full Text)

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December 20, 2017

Vericom Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant Lk Consulting Group USA, Inc 690 Roosevelt Irvine, California 92620

Re: K170950

Trade/Device Name: Well-Root ST Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: November 20, 2017 Received: November 21, 2017

Dear Priscilla 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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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## Page 2 - Priscilla Chung

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Mary S. Runner -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K170950

Device Name

Well-Root™ ST

Indications for Use (Describe)

Permanent sealing of root canal

Type of Use (Select one or both, as applicable)

| <div>☑ Prescription Use (Part 21 CFR 201 Subpart D)</div> | <div>☐ Over-The-Counter Use (21 CFR 201 Subpart C)</div> |
|-----------------------------------------------------------|----------------------------------------------------------|
|-----------------------------------------------------------|----------------------------------------------------------|

> Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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## 510(k) Summary (K170950)

This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

#### Date: 12/15/2017

#### 1. Applicant / Submitter:

Vericom Co., Ltd. 48,Toegyegongdan 1-Gil, Chuncheon-Si, Gangwon-Do, 200-944, Republic of Korea Tel: [phone] Fax: [phone]

#### 2. Submission Correspondent:

Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt Irvine, CA 92620 Phone: [phone] Fax: [phone] Email: [e-mail]

#### 3. Device:

- Trade Name: Well-Root™ ST
- Classification Name: Root Canal Filling Resin
- Classification regulation: 21CFR 872.3820
- Product Code: KIF

#### 4. Predicate Device:

- Primary Predicate Device: AH PLUS ROOT CANAL SEALER (K960548) by Dentsply International
- . Reference Device: iRoot SP (K080917) by Innovative BioCeramix, Inc.

### 5. Description:

Well-Root™ ST is a convenient premixed ready-to use composition which requires the presence of water to set and harden. The device is contained in a plastic syringe and the system includes a plunger, disposable tips, and a holder. We offer the following three types of package configuration. The raw materials including chemical composition of the Well-Root ST Type C (E) and Well-Root ST Type F (for sample) are the same. The only difference between the types are the net weight.

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| Package Type Name | Package Contents |
|---------------------------------|--------------------------------------------------|
| Well-Root ST Type C | 2g Syringe 1ea, Disposable Tip 20ea, Holder 1ea |
| Well-Root ST Type E | 2g Syringe 1ea, Disposable Tip 15ea, Holder 1ea |
| Well-Root ST Type F(for sample) | 0.5g Syringe 1ea, Disposable Tip 3ea, Holder 1ea |

#### 6. Indications for use:

Permanent sealing of root canal

#### 7. Comparison to the Cleared Device

Well-Root™ ST has the same intended use as the predicate devices: AH PLUS ROOT CANAL SEALER (K960548) by Dentsply International and iRoot SP (K080917) by Innovative BioCeramix, Inc. The indication of the statement of the subject device is more simplified than the predicate devices but it does not contain new indications.

All of the devices confirm to ISO 6876 and are provided non-sterile. Both Well-Root™ ST and the iRoot SP (K080917) premixed ready-to-use injectable white hydraulic cement paste.

The difference between the Well-Root™ ST and the primary predicate device (AH PLUS ROOT CANAL SEALER) are delivery form and setting time. However, the differences do not affect to safety and effectiveness of product considerably. Delivery forms are just one of the attributes medical devices have for convenience of use. For the setting time, the test result of the subject device satisfies the requirement of the ISO 6876 and does not raise an issue of safety and/or performance.

We identified the reference device (iRoot SP) for similar raw materials and delivery form premixed ready-to use injectable paste. Well-Root ST is composed of lubricants, radiopaque agent and thickening agents as the reference device. Main materials, Calcium aluminosilicate compound of Well-Root ST is similar to Calcium silicate of the reference device. Also zirconium oxide as radiopaque agent is contained in both subject device and the reference device.

The results of the bench and the biocompatibility tests performed demonstrates that any of these differences do not raise a new question as to safety and effectiveness. Therefore, it is concluded that Well-Root™ ST is substantially equivalent to the predicate device.

| | Subject Device | Primary Predicate<br>Device | Reference Device |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Well-Root™ ST | AH PLUS ROOT<br>CANAL SEALER | iRoot SP |
| Manufacturer | VERICOM CO., LTD. | Dentsply International | Innovative BioCeramix,<br>Inc. |
| 510K Number | K170950 | K960548 | K080917 |
| Product Code | KIF | KIF | KIF |
| | | | |
| Indications for Use | Permanent sealing of<br>root canal | AH PLUS Root Canal<br>Sealer is used for<br>permanent sealing of root<br>canals following<br>established endodontic<br>procedures. | • Permanent obturation of<br>the root canal following<br>vital pulp-extirpation<br>• Permanent obturation of<br>the root canal following<br>removal of infected or<br>necrotic pulp and<br>placement of intracanal<br>dressings.<br>iRoot SP is suitable for use<br>in the single cone and<br>lateral condensation<br>technique. |
| | Insoluble, radiopaque<br>material based on a<br>calcium aluminosilicate<br>compound containing: | Epoxy resin paste(Paste<br>A) and the amine-<br>containing paste(Paste B)<br>containing: | Insoluble, radiopaque<br>material based on a<br>calcium silicate compound<br>containing: |
| Raw materials | Lubricants<br>Zirconium oxide<br>Calcium sulfate<br>dihydrate<br>Titanium dioxide<br>Inorganic glass(Calcium<br>sodium phosphosilicate) | Paste A<br>Bisphenol-A epoxy resin<br>Bisphenol-F epoxy resin<br>Calcium tungstate<br>Zirconium oxide<br>Silica<br>Iron oxide pigments | Thickening agent<br>Zirconium oxide<br>Filler |
| | Calcium aluminosilicate<br>compound | Paste B<br>Dibenzyldiamine<br>Aminoadamantane<br>Tricyclodecane-diamine<br>Calcium tungstate<br>Zirconium oxide<br>Silica<br>Silicone oil | Calcium phosphate<br>monobasic<br>Calcium hydroxide<br>Calcium<br>silicates(Tricalcium<br>silicate, Dicalcium<br>silicate) |
| Principle of operation | Well-Root™ ST is a<br>convenient premixed<br>ready-to-use injectable<br>white hydraulic cement<br>paste developed for<br>permanent root canal<br>filling and sealing<br>applications. Well-<br>Root™ ST is an<br>insoluble, radiopaque<br>material which sets and<br>hardens with moisture<br>providing from dentin<br>tubules during hydration<br>reaction. Well-Root™<br>ST is packaged in a pre-<br>loaded syringe and is<br>supplied with disposable<br>tips. | AH Plus Root Canal<br>Sealer consists of two<br>components, the epoxy<br>resin paste(Paste A) and<br>the amine-containing<br>paste(Paste B) portions<br>which are mixed prior to<br>insertion into the root<br>canal.<br>AH Plus Root Canal<br>Sealer is two-component<br>systems that react via an<br>epoxide/amine chemical<br>reaction to cause setting. | iRoot SP is a convenient<br>premixed ready-to-use<br>injectable white hydraulic<br>cement paste developed<br>for permanent root canal<br>filling and sealing<br>applications. iRoot SP is<br>an insoluble, radiopaque<br>material which requires<br>the presence of water to<br>set and harden. iRoot SP is<br>packaged in a pre-loaded<br>syringe and is supplied<br>with disposable tips. |
| Performance<br>Standard<br>Conformance | Conformed to ISO 6876 | Conformed to ISO 6876 | Conformed to ISO 6876 |
| Biocompatibility | Yes | Yes | Yes |
| Use | Prescription / Hospital | Prescription / Hospital | Prescription / Hospital |
| Delivery Forms | Single paste | Manual mixing of paste<br>A and paste B | Single paste |
| Sterility | Non-sterile | Non-sterile | Non-sterile |

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#### 8. Performance Data

The following testing was conducted on our subject device:

- . Shelf Life: Appearance, ISO 6876 tests (Flow, Setting Time, Film Thickness)
- ISO 6876: Flow, Film Thickness, Solubility and disintegration, Radio-opacity, Working time
- ISO 10993-5 (Cytotoxicity), 10993-10 (Sensitivity-LLNA, GPMT), 10993-11 (Acute ● systemic Totoxicity), ISO 10993-3 (Genotoxicity-Bacterial reverse mutation(Ames), In vitro mammalian chromosomal aberration), ISO10993-6 (Implantation)

The subject device is different from the predicate devices in shelf life and raw materials, however, the test results provided in this submission supports that it is substantially equivalent to the predicate devices.

#### 9. Conclusion

Based on documentation supplied with this submission, conclusions drawn from the testing results demonstrate that the subject device is substantially equivalent to our legally marketed predicate devices.