(132 days)
Not Found
None
No
The device is a chemical etchant and the summary contains no mention of AI, ML, or any computational processing.
No
Explanation: The device is a phosphoric acid etchant used for preparing tooth surfaces prior to restoration, which is a preparatory step and not a direct treatment or therapy for a disease or condition.
No
Explanation: Premier Etch is described as an etchant used for tooth preparation prior to restoration, not for diagnosing a condition or disease.
No
The device is described as a gel form of phosphoric acid etchant, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use of Premier Etch is for etching dentin or enamel prior to tooth restoration. This is a direct application to the tooth structure within the mouth, not an examination of a bodily specimen.
- The description focuses on a chemical etchant for dental procedures. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
Therefore, Premier Etch falls under the category of a dental device used for a restorative procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Premier Etch is a prescription- only, 37% phosphoric acid etchant in a gel form that is used by the dental professional for etching dentin or enamel prior to tooth restoration.
Product codes
KLE
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dentin or enamel (tooth)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professional
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three faces in profile, stacked on top of each other, forming a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 17,2014
Premier Dental Company Products Mr. Vincent D'Alessandro Regulatory Manager 1710 Romano Drive Plymouth Meeting, PA 19462
Re: K141839
Trade/Device Name: Premier Etch Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: November 7, 2014 Received: November 7, 2014
Dear Mr. D'Alessandro:
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.
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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/Resourcesfor You/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/2/Picture/0 description: The image displays the word "CONFIDENTIAL" in large, bold, red letters. The font is sans-serif, and the letters are evenly spaced. The word is centered and fills most of the frame, conveying a sense of importance and secrecy.
Image /page/2/Picture/1 description: The image shows the word "premier" in red, bold letters. The word is inside of a red oval with rounded corners. The background is white.
1710 Romano Drive, Plymouth Meeting, PA 19462 U.S.A. 888-773-6872 / 610-239-6000 www.premusa.com
Indications for Use
510(k) Number (if known): _K141839
Device Name: Premier Etch
Indications for Use: Premier Etch is a prescription- only, 37% phosphoric acid etchant in a gel form that is used by the dental professional for etching dentin or enamel prior to tooth restoration.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)