(279 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of an impression material, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is an impression material used for dental impressions, which is a diagnostic and restorative aid, not a therapeutic agent that treats or cures a disease.
No
Explanation: The Sildent is described as an "impression material" used to create physical impressions of teeth and oral structures for dental restorations. While these impressions are essential for planning treatments, the material itself does not provide diagnostic information by detecting, characterizing, or monitoring diseases or conditions. Its purpose is to physically replicate anatomical structures, not to interpret biological data for diagnosis.
No
The device is described as a vinyl polysiloxane silicone impression material, which is a physical substance, not software.
Based on the provided information, the Sildent device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Sildent is a "vinyl polysiloxane silicone impression material used for all inlay, crown and bridge, edentulous and partial impressions." This describes a material used to create physical impressions of anatomical structures within the mouth.
- Device Description: The description reinforces that it's an "impression material."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in a laboratory setting or at the point of care to analyze biological samples.
The Sildent is a dental material used for creating physical molds, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The Sildent is a vinyl polysiloxane silicone impression material used for all inlay, crown and bridge, edentulous and partial impressions.
Product codes (comma separated list FDA assigned to the subject device)
ELW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 VINYL
POLYSILOXANE
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.
1
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 | ||||||||||||
| Light | Sildent | |||||||||||
| Regular | Sildent | |||||||||||
| Heavy | Sildent | |||||||||||
| Putty | Light | |||||||||||
| Flow | Mono | |||||||||||
| phase | Heavy | |||||||||||
| Tray | Easy | |||||||||||
| Putty | Light | |||||||||||
| Body | Regular | |||||||||||
| Body | Heavy | |||||||||||
| Body | STD | |||||||||||
| putty | ||||||||||||
| 510(k) Number | N/A | K000629 | K882690 | |||||||||
| Intended Use | The Sildent is a vinyl | |||||||||||
| polysiloxane silicone | ||||||||||||
| impression material used for | ||||||||||||
| all inlay, crown and bridge, | ||||||||||||
| edentulous and partial | ||||||||||||
| impressions. | Identical | Identical | ||||||||||
| Material | Additional Polyvinyl Silicone | |||||||||||
| Impression Material | Additional Polyvinyl Silicone | |||||||||||
| Impression Material | Additional Polyvinyl Silicone | |||||||||||
| 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.
2
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.
3
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.
4
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
5
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