(134 days)
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No
The 510(k) summary describes a dental cement and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is a resin cement used for the cementation of dental restorations, which is a supportive material for a therapeutic outcome rather than a therapeutic device itself.
No
The device is described as a cement for dental restorations, indicating it is used for treatment/adhesion rather than diagnosis.
No
The device is described as a "Zeramic Adhesive Resin Cement," which is a physical material used for dental procedures, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Zeramic Adhesive Resin Cement's Intended Use: The intended use of Zeramic Adhesive Resin Cement is for the cementation of dental restorations (inlays, onlays, crowns, bridges, etc.) and posts. This is a direct application within the body (or on a restoration that will be placed in the body), not a test performed on a sample taken from the body.
The description clearly indicates a material used for bonding dental components, which falls under the category of a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Zeramic Adhesive Resin Cement is a prescription only, dual cured, radiopaque resin cement intended to be used for cementation of porcelain, ceramic, resin, metal-based inlays/onlays, crowns, bridges, core build up material, posts and veneers. It is also used for cementation of crown restorations to implants.
Product codes
EMA
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.
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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 features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 22, 2015
Premier Dental Company Products Mr. Vincent D'Alessandro Regulatory Manager 1710 Romano Drive Plymouth Meeting, PA 19462
Re: K150601
Trade/Device Name: Zeramic Adhesive Resin Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: March 6, 2015 Received: June 25, 2015
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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Page 2 - Mr. Vincent D'Alessandro
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,
Tina
Kiang-S
for 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
Enclosure
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Image /page/2/Picture/0 description: The image shows the word "premier" in red, with a red oval around it. The word is in a bold, sans-serif font. The oval is thick and has rounded corners. The logo is simple and eye-catching.
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): K150601
Device Name: Zeramic Adhesive Resin Cement
Indications for Use: Zeramic Adhesive Resin Cement is a prescription only, dual cured, radiopaque resin cement intended to be used for cementation of porcelain, ceramic, resin, metal-based inlays/onlays, crowns, bridges, core build up material, posts and veneers. It is also used for cementation of crown restorations to implants.
Prescription Use _ X _ AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)