(100 days)
Not Found
No
The device description and performance studies focus on the material properties and chemical reaction of a vinyl polysiloxane impression material, with no mention of AI or ML.
No
The description indicates the device is an impression material used to take the shape of teeth, which is part of a diagnostic or restorative dental procedure, not a therapeutic intervention to treat a disease or condition.
No
The device is described as an impression material used for dental procedures like crown/bridge work and functional peripheries. Its purpose is to create a physical mold, not to diagnose a medical condition or disease.
No
The device description clearly describes a physical material (vinyl polysiloxane) that is mixed and applied, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a "heavy body material" for dental impression techniques (putty/wash, functional peripheries, crown/bridge work). This is a material used in the mouth to create a physical impression of teeth and surrounding structures.
- Device Description: The description details a vinyl polysiloxane material that cures into a solid. This is consistent with a dental impression material used directly on the patient.
- Lack of Diagnostic Purpose: An IVD is a device intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not examine specimens or provide diagnostic information. It is a physical material used to create a mold.
- Performance Studies: The performance studies listed (cytotoxicity, skin irritation, sensitization, and ISO 4823:2015 for elastomeric impression materials) are relevant to a material used in the mouth, not an IVD.
In summary, this device is a dental impression material used directly on the patient, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
this device is to be used as a heavy body material for:
- · Two step putty/wash technique
- · Sigle step putty/wash technique
- · Functional peripheries
- Crown/bridge work
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 conforming to tooth's shape 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 mixes the base with the catalyst, and the chemical reaction
begins. Once the impression material is set and 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
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 test
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 4823:2015 dentistry - elastomeric impression materials
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 contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health and Human Services logo features a stylized human figure, while the FDA part includes the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Neosil Co., Ltd. Yang Ho Dong CEO Onbix Corporation #821 Samil Plaza, 14, Dogok-ro 1-gil, Gangnam-gu Seoul, 06523 Kr
Re: K180565
Trade/Device Name: PEAK NS033CF, PEAK NS017CF Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: February 26, 2018 Received: March 19, 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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
June 13, 2018
1
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.
Mary S. Runner -S
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
510(k) Number (if known) K180565
Device Name PEAK NS033CF PEAK NS017CF
Indications for Use (Describe)
this device is to be used as a heavy body material for:
- · Two step putty/wash technique
- · Sigle step putty/wash technique
- · Functional peripheries
- Crown/bridge work
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY K180565
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 8807.92.
| Submitter Information: | Neosil Co., Ltd.
63,Gongdanseo-ro 18beon-gil, Geumjeong-gu
Busan, 46332, Korea
Tel. +82-51-265-5144 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | Mar 23, 2018 |
Device Information:
Trade Name(s): PEAK NS033CF / PEAK NS017CF Classification Name: impression material Panel: dental Product Code & Regulation: ELW
Predicate Device Information:
K152180 - PEAK NS033C / PEAK NS017C
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 conforming to tooth's shape 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 mixes the base with the catalyst, and the chemical reaction
begins. Once the impression material is set and modified, it is taken to patient"s mouth for use in the transfer bonding process.
Indications for Use:
this device is to be used as a heavy body material for:
- Two step putty/wash technique
- · Sigle step putty/wash technique
- · Functional peripheries
- = Crown/bridge work
Comparison to Predicate Device(s):
This device is equivalent to the predicate devices in its intended use and technological characteristics, including:
4
-
- indications for use
-
- raw material
-
- technological characteristics including setting time, consistency, elastic recovery, strain-in compression etc in accordance with ISO 4823.
-
- performance properties
-
- biocompatibility in accordance with ISO 10993-1
Summary of the technological characteristics compared to the predicate device
The device chemical composition is slightly different than listed in the predicate and therefore the following performance and biocompatibility tests were carried out to show substantial equivalence.
Non-Clinical performance test
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 4823:2015 dentistry - elastomeric impression materials
Conclusion
The subject and predicate devices have similar material properties . characteristics and performance and therefore is substantially equivalent to the K152180 predicate device.