(61 days)
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 Vesta 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.
Orion Vesta Dental Alloy
This document is an FDA 510(k) clearance letter for the Orion Vesta Dental Alloy. It does not contain the kind of detailed information about acceptance criteria, study design, or performance metrics that would be provided in a clinical study report or a more technical submission.
Therefore, I cannot extract the requested information as it is not present in the provided text.
Here's why and what kind of document would contain this information:
- 510(k) Clearance Letter: This letter confirms that a device is substantially equivalent to a legally marketed predicate device. It doesn't typically delve into the specifics of performance testing beyond stating that the device meets its intended use.
- Acceptance Criteria & Performance: This information would be found in the "Performance Data" or "Non-Clinical Testing" sections of the 510(k) submission itself (which is not provided here), or in a specific study report for the device.
- Study Details (Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone): These are all elements of a detailed study design and results, which would be in a clinical or non-clinical study report and not summarized in the clearance letter.
- Training Set Information: This is relevant for AI/ML-based devices, which the Orion Vesta Dental Alloy (a physical dental material) is not.
To answer your request, I would need a document that describes the actual testing and validation performed on the Orion Vesta Dental Alloy, rather than just the FDA's clearance letter.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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 : K981001 Trade Name: Orion Vesta Dental Alloy Requlatory 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. A - --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 action. In addition, FDA may publish further announcements 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
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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 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 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
Timo A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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510(k) Premarket Notification for Orion Vesta Dental Alloy Submitted by european dental imports, inc., Reg#1218814
INDICATIONS FOR USE:
510(K) Number: K981001
Device Name: Orion Vesta 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 Vesta 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)
OR
Over the Counter Use
Susan Runner
(Division Sign-Off)
Division of Dental, Infection Control
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number.
§ 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.