(162 days)
Not Found
No
The device description is for a traditional dental impression material (vinyl polysiloxane) and the performance studies focus on material properties, not algorithmic performance. There are no mentions of AI, ML, or image processing.
No
This device is an impression material used to obtain the structure of teeth and gums, which is a diagnostic or data collection function, not a therapeutic intervention.
No
The device is an impression material used to obtain the structure of teeth and gums, which is a physical modeling process, not a diagnostic one.
No
The device description clearly states it is a vinyl polysiloxane impression material, which is a physical substance used to take impressions of teeth and gums. It involves mixing and curing a material, not software processing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to obtain the structure of a patient's teeth and gums." This is a physical process of creating an impression, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is a material (vinyl polysiloxane) used to create a physical mold. It doesn't analyze biological samples or provide diagnostic information.
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological fluids, tissues, or other samples for the purpose of diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on the physical properties of the material (recovery from deformation, strain, dimensional change, working/setting time, hardness) and biocompatibility, which are relevant for a dental impression material, not an IVD.
In summary, this device is a dental impression material used to create a physical representation of a patient's oral anatomy. It does not perform any in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
"to obtain the structure of a patient's teeth and gums"
Product codes (comma separated list FDA assigned to the subject device)
ELW
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 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."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's teeth and gums
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 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
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
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
1
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
2
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.
3
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-si
Gyeonggi-do, Korea 17998
Tel. +82-31-655-8822 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ho Dong, Yang
Onbix Corporation
#821 Samil Plaza, 14 Dogokro 1-gil
Gangnam-gu, Seoul, Korea (06253)
Tel: *82-2-566-3360 / Fax: *82-2-6280-3360
Email: 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 material
dental |
| Product Code & Regulation: | ELW / 872.3660 |
Predicate Device Information:
K882690 3M Imprint K024034 Zhermack Occulfast Rock
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 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.
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
4
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.
| | HRS Co.,Ltd | 3M ESPE
(K882690) |
|-------------------------------------------------------------|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Model | Sildent | Imprint 3 Quick Step |
| Type | Type 1: Fast Heavy Body
Type 2: Fast Light Body | Type 1 : Quick Step Heavy Body
Type 3 : Quick Step Light Body |
| Intended
Use | to obtain the structure of a
patient's teeth and gums. | to obtain the structure of a patient's
teeth and
gums.(Identical) |
| Applied
standard | ISO4823 | ISO4823 (Identical) |
| Recovery form
deformation | >96.5% | > 99.0% (Similar) |
| This meets the applicable standard ISO4823 standard > 96.5% | | |
| Strain in
compression |
| | HRS Co., Ltd. | Zhermack
(K024034) |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| model | Sildent Bite | Occulfast Rock |
| color | lilac | White
Yellow |
| Base/Catalyst mixing
ratio | 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's
standard DIN 13903.
The difference between the two devices is simply the difference of
measurement 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.