SILDENT

K132869 · Hrs Co., Ltd. · ELW · Jun 19, 2014 · Dental

Device Facts

• Record ID: K132869
• Device Name: SILDENT
• Applicant: Hrs Co., Ltd.
• Product Code: ELW · Dental
• Decision Date: Jun 19, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

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

Device Story

Sildent is a vinyl polysiloxane silicone impression material available in four viscosities: light body, regular body, heavy body, and putty. It is used by dental professionals to create accurate impressions of teeth and oral structures for inlay, crown, bridge, edentulous, and partial dental procedures. The material is supplied in cartridges or as putty and is applied intraorally to capture dental anatomy. The resulting impression serves as a mold for the fabrication of dental restorations. The device is non-sterile and intended for professional use in a clinical dental setting.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility studies (cytotoxicity, systemic toxicity, oral mucosa irritation, sensitization) and performance testing (dimensional change, elastic recovery, strain-in compression, working time, consistency, mixing time) demonstrate safety and effectiveness equivalent to predicates.

Technological Characteristics

Vinyl polysiloxane silicone impression material. Available in light body, regular body, heavy body, and putty forms. Supplied in cartridges or putty containers. Complies with ISO 4823 standards. Non-sterile.

Indications for Use

Indicated for dental impressions including inlay, crown, bridge, edentulous, and partial impressions.

Regulatory Classification

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

• FLEXTIME (K000629)
• IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIAL (K882690)

Submission Summary (Full Text)

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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.: [phone] Fax No .: [phone] 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 VINYL<br>POLYSILOXANE<br>IMPRESSION 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 | | | | | |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|------------------|------------------|------------------------------------------------------|---------------|---------------|------------------------------------------------------|---------------|-----------------|---------------|--------------|
| | Sildent<br>Light | Sildent<br>Regular | Sildent<br>Heavy | Sildent<br>Putty | Light<br>Flow | Mono<br>phase | Heavy<br>Tray | Easy<br>Putty | Light<br>Body | Regular<br>Body | Heavy<br>Body | STD<br>putty |
| 510(k) Number | N/A | | | | K000629 | | | K882690 | | | | |
| Intended Use | The Sildent is a vinyl<br>polysiloxane silicone<br>impression material used for<br>all inlay, crown and bridge,<br>edentulous and partial<br>impressions. | | | | Identical | | | Identical | | | | |
| Material | Additional Polyvinyl Silicone<br>Impression Material | | | | Additional Polyvinyl Silicone<br>Impression Material | | | Additional Polyvinyl Silicone<br>Impression 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 |
|----------------------------------------------------------------|
|----------------------------------------------------------------|

#### 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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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 [phone] or [phone] 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 [phone] or [phone] 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