(13 days)
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No
The provided 510(k) summary describes a dental cement and does not mention any AI or ML capabilities, image processing, or data sets typically associated with AI/ML devices.
No.
The intended use describes the device as a cementing agent for dental restorations and core build-ups, which is a structural and restorative function rather than a therapeutic one.
No
The "Intended Use / Indications for Use" describes the device as being for cementing dental restorations and core build-ups, which are treatment procedures, not diagnostic activities.
No
The intended use describes a dental cement, which is a physical material, 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 being used for cementing dental restorations (posts, crowns, bridges, etc.) and for core build-ups. These are procedures performed directly on the patient's teeth, not on samples taken from the patient's body for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information about a patient's health condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The description of ParaCem Universal DC does not align with this definition.
N/A
Intended Use / Indications for Use
ParaCem Universal DC is indicated for cementing of endodontic posts, crowns, bridges, inlays, onlays, veneers and for core build-ups
Product codes
EMA, KLE
Device Description
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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
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Indicated Patient Age Range
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Intended User / Care Setting
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized representation of a human figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 9 2005
Coltene/Whaledent AG C/O Mr. Henry J. Vogelstein Consultant 1349 Lexington Avenue New York, New York 10128
Re: K053040
Trade/Device Name: ParaCem Universal DC Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Codes: EMA and KLE Dated: October 24, 2005 Received: October 28, 2005
Dear Mr. Vogelstein:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Henry J. Vogelstein
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chiu S. Lin, PhD
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for "coltène whaledent". The logo is in black and white, with the word "coltène" on top and "whaledent" on the bottom. There are two black diagonal lines to the right of the word "coltène". The font is bold and sans-serif.
Coltène/Whaledent AG 510(k) Submission ParaCem Universal DC Indications for use
Indications for use
510(k) Number (if known): mk
Image /page/2/Picture/4 description: The image shows the text 'KO 53040' in a handwritten style. The characters are bold and slightly distorted, giving them a unique, imperfect appearance. The text is arranged horizontally, with a clear separation between the letters and numbers.
Device Name:
ParaCem Universal DC
Indications for use:
- ParaCem Universal DC is indicated for cementing of endodontic posts, crowns, bridges, inlays, onlays, veneers and for core build-ups
× Prescription Use: (21 CFR Part 801 Subpart D) Over-the Counter Use: _ (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
and/or
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ringer
ോം Sign-Off) Cision of Anesthesiology, General Hospital, Intection Control, Dental Devices
Number: K053044