The Sildent is a vinyl polysiloxane silicone impression material used for all inlay, crown and bridge, edentulous and partial impressions.
The Sildent consists of 4 type models. These are Sildent light body, Sildent regular body, Sildent heavy body and Sildent putty.

AI/ML Overview

This describes the acceptance criteria and study proving the device meets those criteria for the Sildent dental impression material.

1. Table of Acceptance Criteria and Reported Device Performance

The submission highlights bench testing against ISO 4823 for various performance characteristics. The acceptance criteria are implicitly that the Sildent device performs comparably to the predicate devices and meets the requirements of ISO 4823.

Performance Characteristic	Acceptance Criteria (Implicit from Predicate & ISO 4823)	Reported Sildent Performance
Biocompatibility	No toxicity, sensitization, or irritation	Demonstrated safe for use
Dimensional Change	Comparable to predicate and within ISO 4823	Demonstrated in testing
Elastic Recovery	Comparable to predicate and within ISO 4823	Demonstrated in testing
Strain-in Compression	Comparable to predicate and within ISO 4823	Demonstrated in testing
Working Time	Comparable to predicate and within ISO 4823	Demonstrated in testing
Consistency	Comparable to predicate and within ISO 4823	Demonstrated in testing
Mixing Time	Comparable to predicate and within ISO 4823	Demonstrated in testing

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes for each of the bench tests (e.g., how many samples were tested for dimensional change). The data provenance is Korea, Republic of, as HRS CO., LTD. is located there. The studies were non-clinical bench tests. The document does not explicitly state if the studies were retrospective or prospective, but bench testing on a new product prior to market release is inherently prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This was a non-clinical bench study, not involving human interpretation or expert ground truth as typically understood in AI/medical imaging studies. The "ground truth" was established by the physical and chemical properties measured according to ISO 4823 and comparison to predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There was no human adjudication process involved in these bench tests.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No. This was a non-clinical bench study for a dental impression material. MRMC studies are typically for diagnostic devices that involve human interpretation of medical images.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, in a sense. The bench tests evaluated the material's inherent physical and chemical properties in a standalone manner, without human intervention or interpretation of results in the way an algorithm's performance might be evaluated. The "algorithm" here is the material itself.

7. Type of Ground Truth Used

The ground truth for the performance characteristics was derived from established scientific measurement standards (ISO 4823) and comparison to the characteristics of legally marketed predicate devices. For biocompatibility, the ground truth was based on the results of standard biocompatibility tests (Cytotoxicity, Sensitization, Short term systemic toxicity, Oral mucosa irritation, Diffusion Test).

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set for this device.

Summary

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HRS CO., LTD. Submitter: block 6 choopal industrial complex 394-1 choopal-ri pyongtaek, KOREA, REPUBLIC OF 451-805 Phone No.: +82-31-655-8822 Fax No .: +82-31-691-6682 Official Correspondent: Choi, Jae-Hyuen Date Summary Prepared: OCT 2013 Sildent Trade Name: Common Name: Dental Impression Material Classification Name: Denta! Impression Material(21 CFR § 872.3660) Product Code: ELW

510(k) SUMMARY

Devices for which substantial equivalence is claimed:

Device Name	FLEXTIME	IMPRINT VINYLPOLYSILOXANEIMPRESSION MATERIAL
510(k) Number	K000629	K882690

Device Description

The Sildent is a vinyl polysiloxane silicone impression material used for all inlay, crown and bridge, edentulous and partial impressions.

The Sildent consists of 4 type models. These are Sildent light body, Sildent regular body, Sildent heavy body and Sildent putty.

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Indications for Use

The Sildent is a vinyl polysiloxane silicone impression material used for all inlay, crown and bridge, edentulous and partial impressions.

Our Device				Flextime			3M ESPE
	SildentLight	SildentRegular	SildentHeavy	SildentPutty	LightFlow	Monophase	HeavyTray	EasyPutty	LightBody	RegularBody	HeavyBody	STDputty
510(k) Number	N/A				K000629			K882690
Intended Use	The Sildent is a vinylpolysiloxane siliconeimpression material used forall inlay, crown and bridge,edentulous and partialimpressions.				Identical			Identical
Material	Additional Polyvinyl SiliconeImpression Material				Additional Polyvinyl SiliconeImpression Material			Additional Polyvinyl SiliconeImpression Material
Form	Cartridge, Putty				Cartridge, Putty			Cartridge, Putty
Standard	ISO 4823				Identical			Identical
Sterility	Non sterile				Non sterile			Non sterile

Summary of Technological Cahracteristics Compared to Predicate
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Non-clinical Performance Data

Biocompatibility study was completed, which demonstrates that the material is safe for its intended use. Sildent was tested through the following tests: Cytotoxicity(Agar Short term systemic toxicity(Oral), Oral mucosa irritation, Diffusion Test), Sensitization.

The 510(k) submission also includes data from bench testing used to evaluate performance characteristics of Sildent as compare to the predicate devices. The characteristics evaluated Dimensional Change, Elastic Recovery, Strain-in Compression, Working Time, Consistency and Mixing Time.

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Clinical Testing

Clinical testing has not been conducted on this product.

Conclusions

Non clinical performance testing demonstrates that Sildent is as safe and as effective as the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 19, 2014

HRS Company Limited Jae-Hyuen Choi Correspondent Block 6 choopal industrial complex 394-1 choopal-ri Pyongtaek, KOREA, 451-805

Re: K132869 ·

Trade/Device Name: Sildent Regulation Number: 21 CFR 872.3660 Regulation Name: Dental Impression Material Regulatory Class: II Product Code: ELW Dated: May 19, 2014 Received: May 21, 2014

Dear Mr. Choi:

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 I ou mayy mercisions 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 finay of subject to additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Choi

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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

MarySBunner-S

Erin I. Keith, M.S. 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): K132869

Device Name: Sildent

Indications for Use:

The Sildent is a vinyl polysiloxane silicone impression material used for all inlay, crown and bridge, edentulous and partial impressions.

Prescription Use ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ (Pari 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sheena A. Gregen 2014.06.19 10:38: 00. 5691

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).