(20 days)
Not Found
Not Found
No
The summary describes a device used for casting dental prostheses, which is a traditional manufacturing process and does not mention any AI/ML components or functions.
No
The device is used to fabricate dental prostheses, which are then placed in the patient's mouth. It does not directly treat or diagnose a disease or condition.
No
The device is used to cast elements of dental prostheses, which are restorative devices, not diagnostic tools. Its function is to fabricate a physical product that is later placed in the patient's mouth, not to identify or characterize a disease or condition.
No
The provided text describes the intended use of a device for casting dental prostheses using precious metals and porcelain. This process inherently involves physical materials and manufacturing steps, indicating a hardware component (e.g., casting equipment, materials). There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used by a dental lab technician to fabricate dental prostheses (inlays, onlays, crowns, bridges, etc.) that are then placed in a patient's mouth by a dentist. This is a manufacturing process for a medical device intended for implantation or placement within the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples, providing diagnostic information, or being used for screening, diagnosis, or monitoring of a medical condition.
Therefore, this device falls under the category of a dental prosthetic manufacturing device, not an IVD.
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, posts, 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 Carrara alloys.
After fabrication and finishing the completed prosthesis is approved and placed in the patient's mouth by the dentist.
Product codes
EJT
Device Description
Not Found
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
dental lab technician, attending dentist
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of 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 or bird-like figure, with three curved lines representing its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 9 1998
Mr. Michael H. Everngam ·President European Dental Imports, Incorporated 49 Emerson Road P.O. Box 799 Durham, New Hampshire 03824-0799
K980597 Re : Carrara PDF, Carrara H, Carrara R Trade Name: Requlatory Class: II Product Code: EJT February 10, 1998 Dated: February 17, 1998 Received:
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 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, Druq, 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 Requlations, Title 21, Parts 800 to 895. A A 1000. For substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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
1
Page 2 - Mr. Everngam
not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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) 594-4618. 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 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,
Patricia Crescentiffe
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Premarket Notification for Carrara Dental Alloys Submitted by european dental imports, inc., Reg#1218814
INDICATIONS FOR USE:
510(K) Number: K980597
Device Name: Carrara Dental Alloys
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, posts, 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 Carrara alloys.
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)
w-w---------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation
(Division Sign-Off) PASS for MSR
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | K980597 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109) | Yes | OR | Over the Counter Use No |
|---|---|---|---|
| --------------------------------------- | ----- | ---- | ------------------------- |