GuttaSil

K190510 · Meta Biomed Co., Ltd. · KIF · May 29, 2019 · Dental

Device Facts

• Record ID: K190510
• Device Name: GuttaSil
• Applicant: Meta Biomed Co., Ltd.
• Product Code: KIF · Dental
• Decision Date: May 29, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GuttaSil is a material for permanent obturation of root canals after vital extirpation and after treatment of pulpal gangrene and temporary filling of the canal.

Device Story

GuttaSil is a root canal filling material consisting of gutta-percha powder in a polyvinylsiloxane matrix. It functions as a cold flowable filling system, allowing simultaneous sealing and obturation of root canals without the need for heating. The device is supplied as a paste in a syringe with auto-mix and Endo tips, a spatula, and mixing pads. It is intended for use by dental professionals in a clinical setting. By eliminating the heating step, the device enables a quicker filling process, potentially improving procedural efficiency for the clinician and reducing chair time for the patient.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility (ISO 10993-1, -5, -10, -11) and performance testing (ISO 6876:2012) covering appearance, weight, packaging, flow, working time, setting time, film thickness, solubility, and radio-opacity.

Technological Characteristics

Silicone-based root canal filling material. Composition: gutta-percha powder, polydimethylsiloxane, platinum catalyst, zirconium dioxide, micro-silver, and coloring. Delivery: syringe with auto-mix tips. Conforms to ISO 6876:2012. Non-sterile. Shelf life: 2 years.

Indications for Use

Indicated for permanent obturation of root canals following vital extirpation or treatment of pulpal gangrene, and for temporary filling of the canal.

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

• GUTTAFLOW (K032662)

Reference Devices

• ADSEAL ROOT CANAL SEALER (K042769)
• METACEM (K171449)

Submission Summary (Full Text)

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May 29, 2019

Meta Biomed Co., Ltd. April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620

Re: K190510

Trade/Device Name: GuttaSil Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF, EKM Dated: February 20, 2019 Received: March 1, 2019

Dear April Lee:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

for Malvina B Eydelman, M.D. Director 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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# Indications for Use

510(k) Number (if known) K190510

Device Name GuttaSil

Indications for Use (Describe)

GuttaSil is a material for permanent obturation of root canals after treatment of pulpal gangrene and temporary filling of the canal.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

## Submitter

META BIOMED CO., LTD. Suk Song Oh 270, Osongsaengmyeong 1-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, South Korea Email: [e-mail] Phone: [phone] Fax: [phone]

## Device Information

- Trade Name: GuttaSil ●
- . Classification Name: resin, root canal filling
- Primary Product Code: KIF
- . Secondary Product Code: EKM
- Panel: Dental
- Regulation Number: 21 CFR 872.3820
- Device Class: Class II
- Date prepared: 05/09/2019

## Predicate Devices:

The subject device is substantially equivalent to the following predicate devices:

Primary Predicate

- K032662, GUTTAFLOW manufactured by COLTENE/WHALEDENT GMBH & CO. KG ●
Reference Devices

- K042769, ADSEAL ROOT CANAL SEALER manufactured by META BIOMED CO., LTD. ●
- K171449, METACEM manufactured by META BIOMED CO., LTD.

# Device Description

GuttaSil, a product in the form of a paste which combines gutta-percha with a sealer. The gutta-percha powder is mixed in a matrix of polyvinylsiloxane. It is convenient since sealing and obturation are simultaneously possible without heating and the root canal can be filled in a quick manner. This device contains a syringe, auto-mix& Endo tips, spatula, and mixing pads.

## Official Correspondent

Withus Group Inc April Lee 106 Superior, Irvine, CA 92620 USA Email: [e-mail] Phone: [phone] Fax: [phone]

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## Indication for Use

GuttaSil is a material for permanent obturation of root canals after vital extirpation and after treatment of pulpal gangrene and temporary filling of the canal.

#### Non-clinical Testing

The following testing was conducted on our subject device:

- Biocompatibility Tests according to ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010, . ISO 10993-11:2006.
- . Performance tests such as Appearance, Weight, Packaging, Flow, Working Time, Setting Time, Film Thickness, Solubility, Radio-opacity according to ISO 6876:2012.
- Shelf Life test: ISO 6876 tests (appearance, package, flow, setting time, and Solubility) ●

## Summary of Technological Characteristics:

The subject device and the predicate device have the same intended use and have the similar technological characteristics and are made of similar materials. They encompass the same range of physical and chemical properties. The subject device and predicate devices are packaged in similar material and use similar methods of application.

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

| | Subject Device | Predicate Device |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Meta Biomed Co., Ltd. | GuttaFlow |
| Device Name | GuttaSil | Coltene/Whaledent GMbH & Company KG |
| 510(k) Number | NA | K032662 |
| Classification Name | resin, root canal filling | resin, root canal filling |
| Product Code | KIF, EKM | KIF, EKM |
| Regulation Number | 21 CFR 872.3820 | 21 CFR 872.3820 |
| Indications for use | GuttaSil is a material for permanent<br>obturation of root canals after vital<br>extirpation and after treatment of pulpal<br>gangrene and temporary filling of the<br>canal. | GuttaFlow is a material for permanent<br>obturation of root canals after vital<br>extirpation and after treatment of pulpal<br>gangrene and temporary filling of the canal. |

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| Raw Material | Gutta-percha powder<br>polydimethylsiloxane<br>platinum catalyst<br>zirconium dioxide<br>micro-silver (preservative)<br>colouring. | Gutta-percha powder<br>polydimethylsiloxane<br>platinum catalyst<br>zirconium dioxide<br>micro-silver(preservative)<br>colouring |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Principle of Operation | a cold flowable filling system for root canals. | a cold flowable filling system for root canals |
| Performance Standard<br>Conformance | Conformed to ISO 6876 | Conformed to ISO 6876 |
| Biocompatibility | Yes | Yes |
| Delivery Forms | Single Paste | Single Paste |
| Sterility | Non-sterile | Non-sterile |
| Shelf Life | 2 years | 2 years |

## Conclusion:

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