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 whatever 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 simply mixes the base with the catalyst, and the chemical reaction begins. Once the impression material is set and slightly modified, it is taken to patient's mouth for use in the transfer bonding process.

AI/ML Overview

The provided text describes a 510(k) summary for the Sildent Fast Light Body, Sildent Fast Heavy Body, and Sildent Bite dental impression materials, which are vinyl polysiloxane elastomers. This document does not detail a study proving the device meets acceptance criteria in the context of AI/ML or diagnostic performance, but rather focuses on substantial equivalence to predicate devices based on technological characteristics and non-clinical performance (biocompatibility).

Therefore, many of the requested fields cannot be filled as they pertain to clinical performance studies typically seen with AI/ML devices or diagnostic tools. However, I can extract information related to the acceptance criteria (performance properties) and the non-clinical studies conducted.

Here's an analysis based on the provided text, addressing the relevant points where information is available:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implied by the applicable standard ISO 4823 and by comparison to the predicate device's performance.

Performance Characteristic	Acceptance Criteria (from ISO 4823 or Predicate)	Sildent Fast Heavy Body Reported Performance	Sildent Fast Light Body Reported Performance	Sildent Bite Reported Performance
Recovery from deformation	> 96.5% (ISO 4823)	> 96.5%	> 96.5%	N/A
Strain in compression	< 10%	< 10%	< 10%	N/A
Linear dimensional change	< 1.5% (ISO 4823)	< 1.5%	< 1.5%	N/A
Working time	Similar to predicate (e.g., 1 min 15 sec - 1 min 30 sec)	1 min 30 sec	1 min 15 sec	30 sec
Intraoral setting time	Similar to predicate (e.g., 2 min 30 sec - 3 min)	3 min	3 min	60 sec
Hardness	> 20 HD (DIN 13903) or 95 Shore A	> 20 HD	N/A	> 20 HD

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "appropriate study" for non-clinical performance but does not specify sample sizes for these tests. The company location is HRS Co., Ltd. in Korea.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable as this is not a study requiring expert-established ground truth for diagnostic or AI/ML performance. The "ground truth" for material properties is based on standardized physical and chemical tests.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable as this is not a study requiring expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This submission concerns dental impression materials, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This submission concerns dental impression materials, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance properties (recovery from deformation, strain in compression, linear dimensional change, working time, intraoral setting time, hardness) is based on physical and chemical measurements performed according to ISO 4823 and DIN 13903 standards.

8. The sample size for the training set

This information is not applicable as there is no training set mentioned; this is not an AI/ML device.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set mentioned; this is not an AI/ML device.

In summary, the provided document focuses on demonstrating substantial equivalence of dental impression materials to predicate devices based on adherence to international standards (ISO 4823, DIN 13903) for physical properties and biocompatibility studies (ISO 10993). It does not contain information related to clinical performance studies, AI/ML device evaluation, or diagnostic accuracy.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right is written in blue and white. The logo is commonly used to identify the FDA and its role in regulating food and drugs in the United States.

HRS Co., Ltd. % Yang Ho Dong CEO Onbix Corporation #821 Samil Plaza, 14 Dogok-ro 1-gil, Gangnam-gu Seul, 06253 KOREA

Re: K181604

Trade/Device Name: Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: August 22, 2018 Received: August 31, 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. 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/cfpmp/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

November 28, 2018

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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.htm); 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 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.

Digitally signed by Mary S Marv S. Mary 3. - Runner-S3
Runner -S33 - Date: 2018.11.28 11:39:11
Runner -S3 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K181604 not yet assigned

Device Name Sildent Fast Heavy Body Sildent Fast Light Body Sildent Bite

Indications for Use (Describe) to obtain the structure of a patient's teeth and gums

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."

Image /page/2/Picture/17 description: The image shows the text "Vol_002 (10) EF" along with "PSC Publishing Services (301) 443-6740". The text appears to be part of a journal or publication. The volume number is 002 and the issue number is 10. The phone number is (301) 443-6740.

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K181604 510(k) SUMMARY

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

Submitter Information:	HRS Co., Ltd.7, Chupalsandan 2-gil, Paengseong-eup, Pyeongtaek-siGyeonggi-do, Korea 17998Tel. +82-31-655-8822
Contact Person:	Ho Dong, YangOnbix Corporation#821 Samil Plaza, 14 Dogokro 1-gilGangnam-gu, Seoul, Korea (06253)Tel: 82-2-566-3360 / Fax: 82-2-6280-3360Email: onbix@naver.com
Date Summary Prepared:	Aug 22, 2018
Device Information:
Trade Name(s):	Sildent Fast Heavy Body, Sildent Fast Light Body,Sildent Bite
Classification Name:Panel:	impression materialdental
Product Code & Regulation:	ELW / 872.3660

Predicate Device Information:

K882690 3M Imprint K024034 Zhermack Occulfast Rock

Device Description:

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

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

Indications for Use:

to obtain the structure of a patient's teeth and gums

Comparison to Predicate Device(s):

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

- indications for use
- technological characteristics
- performance properties

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Summary of the technological characteristics compared to the predicate device new device is substantially equivalent to the predicate device in its technological characteristics stated in the comparison table as below.

<Sildent Fast Heavy Body / Sildent Fast Light Body>

	HRS Co.,Ltd	3M ESPE(K882690)
Model	Sildent	Imprint 3 Quick Step
Type	Type 1: Fast Heavy BodyType 2: Fast Light Body	Type 1 : Quick Step Heavy BodyType 3 : Quick Step Light Body
IntendedUse	to obtain the structure of apatient's teeth and gums.	to obtain the structure of a patient'steeth andgums.(Identical)
Appliedstandard	ISO4823	ISO4823 (Identical)
Recovery formdeformation	>96.5%	> 99.0% (Similar)
This meets the applicable standard ISO4823 standard > 96.5%
Strain incompression	<10% (Fast Heavy)<10% (Fast Light)	< 10% (Quick Step Heavy)< 10% (Quick Step Light)
Lineardimensionalchange	<1.5% (Fast Heavy)<1.5% (Fast Light)	< 0.3% (Quick Step Heavy)< 0.3% (Quick Step Light)
This meets the applicable standard ISO4823 standard < 1.5%
Workingtime	1 min 30sec (Fast Heavy)1 min 15sec (Fast Light)	1 min 15 sec (Quick Step Heavy)1 min 30 sec (Quick Step Light)
The curing time of both devices is similar
Intraoralsetting time	3 min (Fast Heavy)3 min (Fast Light)	2 min 30 Sec (Quick Step Heavy)2 min 30 Sec (Quick Step Light)
	The curing time of both devices is significantly reduced compared to regularproducts

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	HRS Co., Ltd.	Zhermack(K024034)
model	Sildent Bite	Occulfast Rock
color	lilac	WhiteYellow
Base/Catalyst mixingratio	1:1	1:1
Working time	30sec	30sec
Time in mouth	60sec	60sec
	More than 20HD	95 shore A
hardness	The subject device is developed for standard> 20 HD in Bite'sstandard DIN 13903.The difference between the two devices is simply the difference ofmeasurement method and does not affect safety and effectiveness.

Non-Clinical Study performance

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 10993-11 systemic toxicity

Conclusion

New device has the same device characteristics as the predicate device, Based on the information provided in this summary we conclude that New device is substantially equivalent to the predicate device K882690 3M Imprint / K024034 Zhermack Occulfast Rock.

Regulation Number and Section

§ 872.3660 Impression material.

(a)
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.(b)
Classification. Class II (Special Controls).