← Product Code [ELW](/productcode/ELW) · K180565

# PEAK NS033CF, PEAK NS017CF (K180565)

_Neosil Co., Ltd. · ELW · Jun 13, 2018 · Dental · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K180565

## Device Facts

- **Applicant:** Neosil Co., Ltd.
- **Product Code:** [ELW](/productcode/ELW.md)
- **Decision Date:** Jun 13, 2018
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3660
- **Device Class:** Class 2
- **Review Panel:** Dental

## Indications for Use

this device is to be used as a heavy body material for: - · Two step putty/wash technique - · Sigle step putty/wash technique - · Functional peripheries - Crown/bridge work

## Device Story

PEAK NS033CF and PEAK NS017CF are vinyl polysiloxane (addition-reaction silicone) impression materials. Supplied as a two-part system (base and catalyst) in separate containers; mixed by the clinician immediately prior to use. Upon mixing, the material cures into a rubber-like solid, conforming to the surface of the teeth to create a dental impression. Used by dental professionals in a clinical setting for restorative procedures including crown and bridge work. The resulting impression is used in the transfer bonding process for dental restorations. Benefits include accurate replication of tooth surface geometry for dental prosthetic fabrication.

## Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including ISO 4823:2015 (elastomeric impression materials), ISO 10993-5 (cytotoxicity), and ISO 10993-10 (skin irritation and sensitization).

## Technological Characteristics

Vinyl polysiloxane (addition-reaction silicone) elastomer. Two-part system. Properties (setting time, consistency, elastic recovery, strain-in compression) conform to ISO 4823:2015. Biocompatibility conforms to ISO 10993-1. Non-electronic, chemical-based impression material.

## Regulatory Identification

Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

## Special Controls

*Classification.* Class II (Special Controls).

## Predicate Devices

- PEAK NS033C / PEAK NS017C ([K152180](/device/K152180.md))

## Submission Summary (Full Text)

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Neosil Co., Ltd. Yang Ho Dong CEO Onbix Corporation #821 Samil Plaza, 14, Dogok-ro 1-gil, Gangnam-gu Seoul, 06523 Kr

Re: K180565

Trade/Device Name: PEAK NS033CF, PEAK NS017CF Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: February 26, 2018 Received: March 19, 2018

Dear Yang Ho Dong:

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);

June 13, 2018

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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 medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) K180565

Device Name PEAK NS033CF PEAK NS017CF

Indications for Use (Describe)

this device is to be used as a heavy body material for:

- · Two step putty/wash technique
- · Sigle step putty/wash technique
- · Functional peripheries
- Crown/bridge work

| 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 K180565

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 8807.92.

| Submitter Information: | Neosil Co., Ltd.<br>63,Gongdanseo-ro 18beon-gil, Geumjeong-gu<br>Busan, 46332, Korea<br>Tel. +82-51-265-5144                                                                         |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person:        | Ho Dong, Yang<br>Onbix Corporation<br>#821 Samil Plaza, 14 Dogokro 1-gil<br>Gangnam-gu, Seoul, Korea (06253)<br>Tel: *82-2-566-3360 / Fax: *82-2-6280-3360<br>Email: onbix@naver.com |
| Date Summary Prepared: | Mar 23, 2018                                                                                                                                                                         |

#### Device Information:

Trade Name(s): PEAK NS033CF / PEAK NS017CF Classification Name: impression material Panel: dental Product Code & Regulation: ELW

#### Predicate Device Information:

K152180 - PEAK NS033C / PEAK NS017C

#### Device Description:

Vinyl polysiloxane is an addition-reaction silicone elastomer (an addition silicone). It is a viscous liquid that cures quickly into a rubber-like solid, taking the shape of conforming to tooth's shape surface it was lying against while curing. As with 2-part epoxy, its package keeps its 2 component liquids in separate container until the moment they are mixed and applied, because once mixed, they cure (harden) rapidly.

To create the material, the user mixes the base with the catalyst, and the chemical reaction

begins. Once the impression material is set and modified, it is taken to patient"s mouth for use in the transfer bonding process.

#### Indications for Use:

this device is to be used as a heavy body material for:

- Two step putty/wash technique
- · Sigle step putty/wash technique
- · Functional peripheries
- = Crown/bridge work

#### Comparison to Predicate Device(s):

This device is equivalent to the predicate devices in its intended use and technological characteristics, including:

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- * indications for use
- * raw material
- * technological characteristics including setting time, consistency, elastic recovery, strain-in compression etc in accordance with ISO 4823.
- * performance properties
- * biocompatibility in accordance with ISO 10993-1

#### Summary of the technological characteristics compared to the predicate device

The device chemical composition is slightly different than listed in the predicate and therefore the following performance and biocompatibility tests were carried out to show substantial equivalence.

#### Non-Clinical performance test

To be in compliance with electromagnetic safety and compatibility, appropriate study has been applied to the new device in accordance with the following standard

ISO 10993-5 cytotoxicity

ISO 10993-10 skin irritation, sensitization

ISO 4823:2015 dentistry - elastomeric impression materials

#### Conclusion

The subject and predicate devices have similar material properties . characteristics and performance and therefore is substantially equivalent to the K152180 predicate device.

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**Source:** [https://fda-staging.innolitics.com/device/K180565](https://fda-staging.innolitics.com/device/K180565)

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