(64 days)
Not Found
No
The 510(k) summary describes a dental alloy and its intended uses and performance studies related to biocompatibility. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML.
No
The device is a dental alloy used for constructing various dental prosthetics, which is a material, not a therapeutic device designed to treat or diagnose.
No
The device description states it is a dental alloy used for constructing inlays, crowns, bridges, and other dental prostheses, which are restorative, not diagnostic, purposes. The performance studies also focus on biocompatibility (cytotoxicity and mutagenicity), not diagnostic accuracy.
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 describes the construction of 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 a condition.
- Device Description: The device is a dental alloy, a material used in the construction of these prosthetics.
- 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 biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The performance studies mentioned (Cytotoxicity and AMES mutagenicity) are related to the biocompatibility and safety of the material for use in the body, which is relevant for a medical device, but not specifically for an IVD.
N/A
Intended Use / Indications for Use
ORION GX ALLOY is used for construction of MOD inlays, crowns, bridges, precision milling bars and attachments, and crowns and bridges for porcelain to metal technique.
Product codes (comma separated list FDA assigned to the subject device)
EJT
Device Description
ORION GX ALLOY is a yellow. 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)
ORION GX ALLOY was tested for Cytotoxicity and AMES mutagenicity and found to be non-cytotoxic and non-mutagenic.
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.
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
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 word is slightly stylized, with the "P" having a unique shape where the loop is replaced by a sharp angle.
NAME & ADDRESS:
SEP 3 0 2003
KO32377
NTSPLY Internationa
0 West College Avenue J. Box 872 York, PA 17405-0872 (717) 845-7511 ax +7-7-7-849-4762 www.dentsply.com
P. J. Lehn Telefax (717) 849-4343
P. Jeffery Lehn CONTACT:
July 25, 2003 DATE PREPARED:
ORION GX ALLOY TRADE OR PROPRIETARY NAME:
Gold-based alloy for clinical use (872.3060) CLASSIFICATION NAME:
PREDICATE DEVICES: Degudent H Alloy K821446
ORION GX ALLOY is a yellow. high noble, gold-based dental DEVICE DESCRIPTION: alloy.
INTENDED USE: ORION GX ALLOY is used for construction of MOD inlays, crowns, bridges, precision milling bars and attachments, and crowns and bridges for porcelain to metal technique.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in ORION GX ALLOY have been used in legally marketed devices.
ORION GX ALLOY is very similar in formulation to legally marketed dental alloys. This alloy has been on the European market since 1978 with over 1.5 million units placed. ORION GX ALLOY was tested for Cytotoxicity and AMES mutagenicity and found to be non-cytotoxic and non-mutagenic. Therefore, it was determined that no further biocompatibility testing was necessary
We believe that the prior use of the components of ORION GX ALLOY in legally marketed devices, the performance data provided, the biocompatibility test results, and the historical use of the device in Europe support the safety and effectiveness of ORION GX ALLOY for the indicated uses.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.
Public Health Service
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: K032317
Trade/Device Name: Orion GX 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
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 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,
Susan Ronan
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
3
INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 807.87(e)
510(K) Number (if known):
Device Name:
ORION GX ALLOY
Indications for Use:
Construction of MOD inlays, crowns, bridges, precision milling bars and attachments, and crowns and bridges for porcelain fused to metal technique.
Mly. U. Su fa NBR
ivision Sinn-Off on of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K032317
(PLEASE DO NOT WRITE BELOW THIS LINE------------------------------------------------------------------------------------------------------------------------------------------
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)