(70 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-fused-to-metal restorations. When used for porcelain-fused-to-metal restorations it is intended by the manufacturer that only Carrara Porcelain products be used with the Cera E alloy. After fabrication and finishing the completed prosthesis is approved and placed in the patient's mouth by the dentist.
Cera E Dental Alloy
The provided document is a 510(k) clearance letter from the FDA for a dental alloy device (Cera E Dental Alloy). It states that the device is substantially equivalent to legally marketed predicate devices.
*However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria related to AI or any other performance metrics typically associated with detailed device performance studies.
The letter is a regulatory approval, not a scientific study report. It focuses on:
- Substantial Equivalence: The primary basis for 510(k) clearance is demonstrating that a new device is "substantially equivalent" to a predicate device already on the market. This often means similar technological characteristics and indications for use, without raising new questions of safety and effectiveness.
- Intended Use Statement: The "Indications for Use" section (Page 3) describes how the device is intended to be used (e.g., by a dental lab technician for specific types of dental prostheses). This is a critical part of the regulatory submission.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance based on the provided text. The document simply doesn't contain that kind of information.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
। 10008 MAY
Ms. Gisela N. Everngam ·Sales Director Official Correspondent European Dental Imports, Incorporated 49 Emerson Road P.O. Box 799 Durham, New Hampshire 03824-0799
Re : K980661 Cera E Dental Alloy Trade Name: Requlatory Class: II Product Code: EJS Dated: February 12, 1998 Received: February 20, 1998
Dear Ms. 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 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. ਮੈ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 through 542 of
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Page 2 - Ms. Everngam
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 requlation (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" (21 CFR 807.97) . Other gener 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/dsmamain.html".
Sincerely yours
Timothy R. Ulbrich
Timothy A Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Premarket Notification for Cera E Dental Alloy Submitted by european dental imports, inc., Reg#1218814
INDICATIONS FOR USE:
510(K) Number:
Cera E Dental Alloy Device Name:
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.
When used for porcelain-fused-to-metal restorations it is intended by the manufacturer that only Carrara Porcelain products be used with the Cera E alloy.
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
| (Division Sign-Off) | |
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number |
| Prescription Use | OR | Over the Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) |
§ 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.