(240 days)
Not Found
Not Found
No
The device is described as a dental impression material, which is a physical substance used to create molds. There is no mention of software, algorithms, or any computational processing that would involve AI or ML.
No
This device is an impression material used for making dental impressions, it does not provide therapy or treatment.
No
Explanation: The device, PERFIT, is an impression material used to create molds of teeth and oral structures, which is a step in treatment planning and fabrication of prosthetics, not for diagnosing a medical condition.
No
The device is described as a physical material (silicone impression material) and does not mention any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the material as a dental impression material used for creating molds of teeth and oral structures. This is a physical process for creating a replica, not a diagnostic test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description confirms it's a dental impression material.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic purposes.
IVD devices are typically used to examine specimens such as blood, urine, or tissue to detect diseases, conditions, or infections. This dental impression material does not fit that description.
N/A
Intended Use / Indications for Use
A Silicone Dentistry-Elastic Impression Material, with the trade name of PERFIT, is an addition-cure vinyl polysiloxane dental inyression material that is used for all crown und bridge, edentulous, orthodonic and impliant impression techniques.
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device Description
A Silicone Dentistry-Elastic Impression Material, with the trade name of PERFIT, is an addition-cure vinyl polysiloxane dental inyression material.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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 seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes on its wing, representing service, science, and protection. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
May 28, 2014
Rizhao Huge Dental Industry Company, Limited C/O Ms. Helen Nan General Manager Wenzhou Cytech Information Service Company, Limited Room 302, Number 21 Building, Kaiyu Garden, Xishan South Road, Wenzhou City, 325000, Zhejiang Province CHINA
Re: K133071
Trade/Device Name: PERFIT Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: November 15, 2013 Received: March 12, 2014
Dear Ms. Nan:
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.
1
Page 2 - Ms. Nan
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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
MaryStBunner-S
Erin I. Keith, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
Indications for Use
510(k) Number (if known) K133071
Device Name
A Silicone Dentistry-Elastic Impression Material
Indications for Use (Describe)
A Silicone Dentistry-Elastic Impression Material, with the trade name of PERFIT, is an addition-cure vinyl polysiloxane dental inyression material that is used for all crown und bridge, edentulous, orthodonic and impliant impression techniques.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (1/14)
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