(175 days)
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No
The provided text describes a dental luting cement and its intended uses. There is no mention of any software, image processing, or terms related to AI/ML.
No
The intended uses listed describe the luting (cementing) of dental prosthetics and devices, which are restorative and protective functions, not therapeutic.
No
The Intended Use/Indications for Use section describes the device's function as "Luting," which is the process of cementing or bonding dental restorations. This activity is therapeutic or restorative, not diagnostic. A diagnostic device would typically involve identifying diseases, conditions, or problems.
No
The intended use describes the luting (cementing) of various dental prosthetics and devices. This is a physical process involving materials and their application, not a software function. The lack of a device description further supports that this summary is for a physical material or device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to the luting (cementing) of various dental restorations (crowns, bridges, inlays, onlays, posts, bands) within the mouth. This is a direct application to the patient's body for structural support and restoration.
- Definition of IVD: An In Vitro Diagnostic device is used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information about a physiological state, health, disease, or congenital abnormality.
The provided information clearly describes a dental cement used for bonding materials within the patient's mouth, which falls under the category of a medical device but not specifically an IVD.
N/A
Intended Use / Indications for Use
- Luting of metal-based crowns, bridges, inlays and onlays
- Luting of high-strength all-ceramic crowns and bridges (such as aluminum oxide, lithium di silicate and zirconium oxide ceramics)
- Luting of metal-based and high-strength all-ceramic crowns and bridges (such as aluminum oxide, lithium disilicate and zirconium oxide ceramics) on implant abutments
- Luting of metal root posts or indirect metal post core build-ups
- Luting of prefabricated steel crowns
- Luting of orthodontic bands
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
Prescription Use
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.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 14, 2013
VOCO GmbH Dr. T. Gerkensmeier Regulatory Affairs Anton-Flettner-Strabße 1-3 27472 Cuxhaven
Re: K130421
Trade/Device Name: Meron Application Capsules Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: July 10, 2013 Received: July 15, 2013
Dear Dr. Gerkensmeier:
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 - Dr. Gerkensmeier
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/1/Picture/6 description: The image shows the text "Mary S. Runner - S". The words "Mary" and "Runner" are written in a bold, sans-serif font. The letter "S" is written in a similar font, but it is outlined with a thin line. The words "S. Runner" are also surrounded by a decorative border.
Kwame Ulmer 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
Indications for Use Statement
| 510(k) Number: | K130421 |
|---|---|
| Device Name: | Meron/application capsules |
| Indications for Use: |
- Luting of metal-based crowns, bridges, inlays and onlays
- Luting of high-strength all-ceramic crowns and bridges (such as aluminum oxide, lithium di silicate and zirconium oxide ceramics)
- Luting of metal-based and high-strength all-ceramic crowns and bridges (such as aluminum oxide, lithium disilicate and zirconium oxide ceramics) on implant abutments
- Luting of metal root posts or indirect metal post core build-ups
- Luting of prefabricated steel crowns
- Luting of orthodontic bands
| Prescription Use | X |
|---|---|
| OR | Over-The-Counter Use |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sheena A. Green
2013.08.14 11:31:55-04'00'
for M. Susan Runner, DDS, MA
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K130421 |
|---|---|
| ---------------- | --------- |
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