(64 days)
Not Found
No
The 510(k) summary describes a dental alloy, which is a material used for fabricating dental prosthetics. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
CERA F ALLOY is a dental alloy used to fabricate prosthodontic devices, it is not a therapeutic device itself.
No
The device is a dental alloy used for fabricating prosthetic devices, not for diagnosing medical conditions.
No
The device description clearly states it is a gold-based dental alloy, which is a physical material, not software.
Based on the provided information, the device "CERA F ALLOY" is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for fabricating dental prosthetics (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 or monitor a condition.
- Device Description: It's described as a "gold-based dental alloy for prosthodontic devices." This further reinforces its role as a material for creating dental restorations.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing diagnostic or monitoring information
Therefore, CERA F ALLOY is a dental material used in the creation of a medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
CERA F ALLOY is indicated as a dental alloy for fabricating inlays, crowns, bridges, precision milling bars and attachments, and crowns and bridges for porcelain fused to metal technique.
Product codes
EJT
Device Description
CERA F ALLOY is a gold-based dental alloy for prosthodontic devices.
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
The alloy has been on the European market since 2001 with over 250,000 units placed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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510(k) SUMMARY
NAME & ADDRESS:
SEP 3 0 2003
DENTSPLY International
70 West College Avenue O. Box 872 York, PA 17405-0872 717) 845-7511 772 840 1762 ww.dentsply.com
P. J. Lehn Telefax (717) 849-4343
P. Jeffery Lehn CONTACT:
July 25, 2003 DATE PREPARED:
TRADE OR PROPRIETARY NAME: CERA F ALLOY
Gold based alloy for clinical use (872.3060) CLASSIFICATION NAME:
PREDICATE DEVICES: Stabilor NF IV alloy K951780
DEVICE DESCRIPTION: CERA F ALLOY is a gold-based dental alloy for prosthodontic devices.
INTENDED USE: CERA F ALLOY is indicated as a dental alloy for fabricating inlays, crowns, bridges, precision milling bars and attachments, and crowns and bridges for porcelain fused to metal technique.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in CERA F ALLOY have been used in legally marketed devices.
CERA F ALLOY is very similar in formulation to legally marketed dental alloys. This alloy has been on the European market since 2001 with over 250,000 units placed. Therefore, it was determined that no biocompatibility testing was necessary.
We believe that the prior use of the components of CERA F ALLOY in legally marketed devices, the performance data provided, and the historical use of the device in Europe support the safety and effectiveness of CERA F ALLOY for the indicated uses.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human profiles facing to the right, stacked on top of each other.
Public Health Service
SEP 3 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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: K032321
Trade/Device Name: Cera F 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.
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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 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 (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,
Suser Purse
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
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INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 807.87(e)
510(K) Number (if known):
Device Name:
CERA F ALLOY
Indications for Use:
Fabricating inlays, crowns, bridges, precision milling bars and attachments, and crowns and bridges for porcelain fused to metal technique.
MCG Lu for MSR
(Division Sign-O Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ V
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)