(64 days)
No
The summary describes a dental alloy, a material, and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a material (gold-based dental alloy) used for fabricating dental prosthetics, which are restorative devices, not therapeutic devices. Therapeutic devices are typically those that treat or cure a disease or condition.
No
Explanation: The device is a gold-based dental alloy used for fabricating prosthodontic devices, which are restorative rather than diagnostic. The "Intended Use / Indications for Use" section focuses on fabrication of dental prosthetics.
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, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for fabricating dental prosthodontic devices (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 to create the prosthetics.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This dental alloy does not fit that description.
N/A
Intended Use / Indications for Use
CERA R PLUS 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 R PLUS 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
Not Found
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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Image /page/0/Picture/0 description: The image shows a black and white abstract shape. The shape is roughly triangular, with the top right corner being the most defined point. The rest of the shape is filled with a grainy texture, giving it a rough and uneven appearance.
510(k) SUMMARY
KQ32319
NAME & ADDRESS:
DENTSPLY International
SEP 3 0 2003
570 West College Avenue O. Box 872 York, PA 17405-0872 717) 845-7511 17 17 1 2 2 2 2 2 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 ww.dentsplv.com
P. J. Lehn Telefax (717) 849-4343
P. Jeffery Lehn CONTACT:
July 25, 2003 DATE PREPARED:
TRADE OR PROPRIETARY NAME: CERA R PLUS ALLOY
CLASSIFICATION NAME: Gold based alloy for clinical use (872.3060)
PREDICATE DEVICES: Stabilor NF IV alloy K951780
CERA R PLUS ALLOY is a gold-based dental alloy for DEVICE DESCRIPTION: prosthodontic devices.
INTENDED USE: CERA R PLUS 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 R PLUS ALLOY have been used in marketed devices.
CERA R PLUS ALLOY is very similar in formulation to legally marketed dental alloys. This alloy has been on the European market since 1998 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 CERA R PLUS 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 R PLUS ALLOY for the indicated uses.
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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle with three heads.
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: K032319
Trade/Device Name: Cera R Plus 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 (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.
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 vours.
Susan Runne
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 R PLUS ALLOY
Indications for Use:
Fabricating inlays, crowns, bridges, precision milling bars and attachments, and crowns and bridges for porcelain fused to metal technique.
thell & the for MSR
hesiology, General Hospital, ontrol Der 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)