(49 days)
Not Found
No
The summary contains no mention of AI, ML, or related concepts, and the device description is not available.
No
The intended use describes the device as being used for "impression techniques" for crowns, bridges, and implants, which indicates it's for diagnostic/measurement purposes rather than direct treatment or therapy.
No
The device is used for impression techniques, which are part of the treatment process for crowns, bridges, and implants, not for diagnosing medical conditions.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components. The intended use suggests a physical impression technique, which typically involves hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "all crown and bridge and implant impression techniques." This describes a process of creating a physical mold of teeth and surrounding structures, which is a mechanical or physical process, not a diagnostic test performed on biological samples in vitro (outside the body).
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
- Predicate Device: The listed predicate device (K042600) would likely be a similar dental impression material or system, which are generally not classified as IVDs.
Therefore, based on the intended use and the absence of any information suggesting in vitro diagnostic testing, this device is not an IVD.
N/A
Intended Use / Indications for Use
Correct is used for all crown and bridge and implant impression techniques.
Product codes
ELW
Device Description
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 2004
Ms. Jung Ung Lee President Handae Chemical Company Limited 560-24, Songdu-Ri, Jincheon-Up, Jincheon-Gun, Chungcheongbuk-Do, Korea. 365-802
Re: K042860
K042600
Trade/Device Name: Correct Dental Impression Material Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: September 30, 2004 Received: October 15, 2004
Dear Ms. Ung Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device t We have reviewed your Section 310(x) preference is substantially equivalent (for the referenced above and have determined the active is marketed prodicate devices marketed in
indications for use stated in the enclosure) to legally marketed profithe Medical De indications for use stated in the chelosares to regardent date of the Medical Device interstate commerce prior to reay 20, 1770, clessified in accordance with the provisions of
Amendments, or to devices that have been receive enproval of a premarket Amendments, or to devices that have been rocassing approval of a premarket.
the Federal Food, Drug, and Cosmetic Act (Act) that do not requires whices to the general the Federal Food, Drug, and Cosmetic Act (110) and the device, subject to the general
approval application (PMA). You may, therefore, subject to the general approval application (1 MA). Tou may, and controls provisions of the Act include controls provisions of the Act. The general venues, good manufacturing practice, requirements for unitudi regainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) of class III If your device is classified (see above) into bandrols. Existing major regulations affecting
(PMA), it may be subject to such additional controls. Existing Title 21, Perts (PMA), it may be subject to such additional controllar controlsons, Title 21, Parts 800 to 898. In
your device can be found in the Code of Federal Regulations, Title 21, Inc your device can be found in the Code of Pederal Negation of the Federal Register.
1
Page 2 - Ms. Ung Lee
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I Dr 3 issualited or that your device complies with other requirements mean that i DA nas made a decemand regulations administered by other Federal agencies. of the Act of ally I ederal statists and squirements, including, but not limited to: registration 1 ou must comply with an the Fiel brog (21 CFR Part 801); good manufacturing practice and fishing (21 CFR Part 807), aboulity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality is a control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anon your even finding of substantial equivalence of your device to a premarket notification. - The PDF results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific at not to real pliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sikon Gunner
Shiao-Lin Lin, Ph.D.
-Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, 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) : K042860
Device Name: Correct Dental Impression Material
Indications for Use:
Correct is used for all crown and bridge and implant impression techniques.
Over-The-Counter Use Prescription Use Y AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINEcontinue on another Page if needed)
Sypor Punoe
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K041666
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1