(64 days)
Not Found
No
The summary describes a dental alloy and its intended uses, with no mention of software, image processing, AI, or ML.
No.
The device is a dental alloy used for fabricating dental prosthetics, which falls under restorative or prosthetic dentistry rather than therapeutic. Its intended use is to replace or restore tooth structure, not to treat a disease or disorder.
No
The device description indicates it is a dental alloy used for fabricating dental restorations, which is a treatment or restorative function, not a diagnostic one.
No
The device description clearly states it is a "high noble, gold-based dental alloy," 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 is for fabricating dental restorations (inlays, crowns, bridges, etc.). This is a manufacturing process for a medical device that will be placed in the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a dental alloy, a material used in the fabrication process.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing samples from the human body (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or other components typically associated with IVD tests
In summary, the MINERVA 58 ALLOY is a material used to create dental prosthetics, which are medical devices, but it is not an in vitro diagnostic device itself.
N/A
Intended Use / Indications for Use
MINERVA 58 ALLOY is indicated as a dental alloy for fabricating MOD inlays, crowns, bridges, precision milling bars and attachments, and partial dentures.
Product codes (comma separated list FDA assigned to the subject device)
EJT
Device Description
MINERVA 58 ALLOY is a high noble, gold-based dental alloy.
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)
We believe that the prior use of the components of MINERVA 58 ALLOY in legally marketed devices, the performance data provided, and the historical use of the device in Europe support the safety and effectiveness of MINERVA 58 ALLOY for the indicated uses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Stabilor G Alloy K951782
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.
0
510(k) SUMMARY
Image /page/0/Picture/1 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are all capitalized and black. The letter "N" has a unique design, with a sharp, angled cut in the middle. The word is horizontally oriented and appears to be a logo or brand name.
NAME & ADDRESS:
SEP 3 0 2003
West ( ollege Avenue PA 17405-087 w.dentsplv.com
P. J. Lehn Telefax (717) 849-4343
P. Jeffery Lehn CONTACT:
DATE PREPARED: July 25, 2003
TRADE OR PROPRIETARY NAME: MINERVA 58 ALLOY
CLASSIFICATION NAME: Gold-based alloy for clinical use (872.3060)
PREDICATE DEVICES: Stabilor G Alloy K951782
DEVICE DESCRIPTION: MINERVA 58 ALLOY is a high noble, gold-based dental alloy.
INTENDED USE: MINERVA 58 ALLOY is indicated as a dental alloy for fabricating MOD inlays, crowns, bridges, precision milling bars and attachments, and partial dentures.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in MINERVA 58 ALLOY have been used in legally marketed devices.
MINERVA 58 ALLOY is very similar in formulation to legally marketed dental alloys. This alloy has been on the European market since 1987 with over 800.000 units placed. Therefore, it was determined that no biocompatibility testing was necessary.
We believe that the prior use of the components of MINERVA 58 ALLOY in legally marketed devices, the performance data provided, and the historical use of the device in Europe support the safety and effectiveness of MINERVA 58 ALLOY for the indicated uses.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of a human figure, represented by three curved lines, with a bird-like shape above it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 3 0 2003
Mr. P Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs Dentsply International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872
Re: K032318
Trade/Device Name: Minerva 58 Alloy Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: July 25, 2003 Received: July 28, 2003
Dear Mr. Lehn:
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.
2
Page 2 - Mr. Lehn
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 (OS) 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 vour 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 (301) 594-4613. 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 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/dsma/dsmamain.html
Sincerely yours,
Susa Rumrr
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 807.87(e)
510(K) Number (if known):
Device Name:
MINERVA 58 ALLOY
Indications for Use:
Fabricating MOD inlays, crowns, bridges, precision milling bars and attachments, and partial dentures.
A.E.Soffe for MSR
nesthesiology, General Hospital. ntrol, Dental Devices
510(k) Number: K032318
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDEL
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)