(61 days)
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Not Found
No
The summary describes a dental alloy and its intended use in casting dental prostheses. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a dental alloy used to fabricate prostheses, not to directly treat a patient. The completed prosthesis is placed in the patient's mouth by a dentist.
No
The device is a dental alloy used for fabricating prostheses, which is a manufacturing process, not a diagnostic one. It is used to create physical dental components, not to identify or analyze medical conditions.
No
The device description clearly states "Orion WX Dental Alloy," indicating a physical material used in dental prostheses, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a dental alloy used by a dental lab technician to cast elements of dental prostheses. These prostheses are then placed in the patient's mouth by a dentist. This is a manufacturing process for a medical device that is implanted or placed in the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is described as a "Dental Alloy," which is a material used in the fabrication of dental devices.
- Lack of IVD Characteristics: The description lacks any mention of analyzing samples from the human body (like blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality. This dental alloy does not fit that definition.
N/A
Intended Use / Indications for Use
Used by a dental lab technician, under the direction of an attending dentist, to cast elements of fixed and removable dental prostheses:
precious metal inlays, onlays, and crowns;
precious metal bridges, bars, and attachments;
precious metal copings and bridges for porcelain-fusedto-metal restorations.
Orion WX is recommended for use with any normal-fusingtemperature porcelain product in porcelain-fused-to-metal restorations of from one crown up to a full-span bridge.
After fabrication and finishing the completed prosthesis is approved and placed in the patient's mouth by the dentist.
Product codes
EJS
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
dental lab technician, under the direction of an attending dentist
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
Not Found
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): 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.
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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.
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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).
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§ 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 logo for the Department of Health & Human Services (HHS). The logo features the department's name encircling a stylized symbol. The symbol consists of three abstract human profiles facing right, with flowing lines beneath them, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY | 8 1998
Mr. Michael H. Everngam ·President European Dental Imports, Incorporated 49 Emerson Road Durham, New Hampshire 03824-0799
Re : K981002 Orion WX Dental Alloy Trade Name: Regulatory Class: II Product Code: EJS Dated: March 9, 1998 Received: March 18, 1998
Dear Mr. Everngam:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. Inc 2001 substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. Everngam
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
2
510(k) Premarket Notification for Orion WX Dental Alloy Submitted by european dental imports, inc., Reg#1218814
INDICATIONS FOR USE:
510(K) Number: K981002
Device Name: Orion WX Dental Alloy
Indications for Use:
Used by a dental lab technician, under the direction of an attending dentist, to cast elements of fixed and removable dental prostheses:
precious metal inlays, onlays, and crowns;
precious metal bridges, bars, and attachments;
precious metal copings and bridges for porcelain-fusedto-metal restorations.
Orion WX is recommended for use with any normal-fusingtemperature porcelain product in porcelain-fused-to-metal restorations of from one crown up to a full-span bridge.
After fabrication and finishing the completed prosthesis is approved and placed in the patient's mouth by the dentist.
(Please do not write below this line) ******************************************************************************************************************************************************************************
Concurrence of CDRH, Office of Device Evaluation
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
Over the Counter Use
Susan Russe
OR
ivision Sign-Off) Division of Dental, Infection Control, and General Hospit 510(k) Number
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