(54 days)
Not Found
No
The summary describes a dental casting alloy and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a casting alloy used by dental technicians to fabricate dental appliances; it is not directly used for therapy in patients.
No
Explanation: The device is a casting alloy used by dental technicians to fabricate dental appliances, not to diagnose medical conditions. Its intended use is for manufacturing dental prosthetics like inlays, onlays, crowns, and bridges.
No
The device is a casting alloy, which is a physical material used to fabricate dental appliances. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "fabricate dental appliances for patients" such as inlays, onlays, crowns, and bridges. This is a manufacturing process for a medical device that will be placed in the patient's mouth.
- Device Description: The description details the composition of a casting alloy used for dental restorations.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose or monitor medical conditions. This device is a material used to create a physical dental restoration.
N/A
Intended Use / Indications for Use
Eco E4 is a silver-palladium casting alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing - Inlays/onlays - Crowns - Short span bridges - Long span bridges Eco E4 can be veneered with suitable dental composites.
Product codes
E12
Device Description
Eco E4 is a high strength silver-palladium casting alloy, intended for dental technicians to fabricate dental restorations. It consists of silver, palladium and gold (93,5%) as well as of copper and zinc. Eco E4 has an indication for use which ranges from inlays/onlays and crowns up to long span bridges with two or more pontics. It complies with the international standard ISO 8891 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
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 technicians
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)
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
K0224169
Premarket Notification 510(k)
Eco E4
5. 510 (k) Summary
SEP 1 8 2002
- Wieland Dental + Technik GmbH & Co. KG Submitter of 510(k): Schwenninger Str. 13 D-75179 Pforzheim Germany Phone: +49-7231-3705-0
| Contact person: | Dr. Gerhard Polzer |
|---|---|
| Phone: | +49-7231-3705-219 |
| Fax: | +49-7231-357959 |
| e-mail: | gerhard.polzer@wieland-dental.de |
Date of Summary: 2002-07-23
Trade name: Eco E4
Classification name: Product code: E12 C.D.R section: 872.3060 Classification: Class II
Alloy, Precious metal, for clinical use
Legally marketed Pagalin 2 equivalent device: 510(k) number: K911675
Device description
Eco E4 is a high strength silver-palladium casting alloy, intended for dental technicians to fabricate dental restorations.
It consists of silver, palladium and gold (93,5%) as well as of copper and zinc.
Eco E4 has an indication for use which ranges from inlays/onlays and crowns up to long span bridges with two or more pontics.
It complies with the international standard ISO 8891 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of flowing lines, possibly representing the interconnectedness of health and human services.
Public Health Service
SEP 1 8 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Gerhard Polzer Director, Regulatory Affairs Wieland Dental + Technik GmbH & Company KG Schwenninger Straße 13 D-75179 Pforzheim GERMANY
Re: K022469
Trade/Device Name: Eco E4 Regulation Number: 21 CFR 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJS Dated: July 23, 2002 Received: July 26, 2002
Dear Dr. Polzer:
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.
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.
2
Page 2 - Dr. Polzer
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Timothy A. Ulatowski
Timo Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
1 1
Page _ of _
510(k) Number (if known)
Eco E4
Device Name:_
、
Indications For Use:
Eco E4 is a silver-palladium casting alloy that can be used by dental technicians to fabricate dental appliances for patients.
It is intended for manufacturing
- Inlays/onlays
- Crowns
- Short span bridges
- Long span bridges
Eco E4 can be veneered with suitable dental composites.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| OR | |
| Over-The-Counter Use_____ |
| (Per 21 CFR 801.109) | (Division Sign-Off) |
|---|---|
| Susan Rogers | |
| (Optional Format 1-2-96) |
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
| 510(k) Number: | KO24169 |
|---|---|
| ---------------- | --------- |