(52 days)
K 913704
Not Found
No
The 510(k) summary describes a dental alloy material and its intended uses, with no mention of software, algorithms, or any technology related to AI or ML.
No
Simidur KF plus is a palladium-base ceramic alloy used by dental technicians to fabricate dental appliances. It is a material used in the manufacturing process rather than a device intended for direct therapeutic action on a patient.
No
The device is a palladium-base ceramic alloy used by dental technicians to fabricate dental appliances, not to diagnose medical conditions.
No
The device description clearly states it is a palladium-base ceramic alloy, which is a physical material, 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. This is a medical device used in vivo (within the body) or for creating devices that will be used in vivo.
- Device Description: The description confirms it's a material used by dental technicians to create 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 typically used in laboratories or clinical settings to analyze samples like blood, urine, or tissue to diagnose diseases, monitor health, or determine compatibility. This device is a material used to create physical dental prosthetics.
N/A
Intended Use / Indications for Use
Simidur KF plus is a palladium-base ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients.
It is intended for manufacturing
- Crowns
- Short span bridges
- Long span bridges
- Removable partials
and can be used for
- . Telescopic and milling work
Simidur KF plus can be veneered with suitable dental ceramics as well as with dentalcomposites.
Product codes (comma separated list FDA assigned to the subject device)
ETS, EJS
Device Description
Simidur KF plus is a palladium-base ceramic alloy (79,7% Palladium), intended for dental technicians to fabricate dental restorations.
It has an indication which ranges from single crowns up to long span bridges with two or more pontics and to removable partials. It is free of copper and suitable for telescopic and milling work.
Simidur KF plus is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
Simidur KF plus can be veneered with suitable dental ceramics and with dental composites.
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): 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.
K 913704
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.
Not Found
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).
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
K 020194
Premarket Notification 510(k)
MAR 1 5 2002
Simidur KF plus
510 (k) Summary 5.
Submitter of 510(k):
Wieland Dental + Technik GmbH & Co. KG 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 |
2001-12-14
Date of Summary:
Trade name:
Simidur KF plus
Classification name: Product code: C.D.R section: Classification:
Alloy, precious metal, for clinical use ETS 872.3060 Class II
Legally marketed Argebond 80 equivalent device: K 913704 510(k) number:
Device description
Simidur KF plus is a palladium-base ceramic alloy (79,7% Palladium), intended for dental technicians to fabricate dental restorations.
It has an indication which ranges from single crowns up to long span bridges with two or more pontics and to removable partials. It is free of copper and suitable for telescopic and milling work.
Simidur KF plus is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
Simidur KF plus can be veneered with suitable dental ceramics and with dental composites.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2002
Dr. Gerhard Polzer Director, Regulatory Affairs Wieland Dental + Technik GmbH & Co. KG Schwenninger Strasse 13 75120 Pforzheim, GERMANY
Re: K020194
Trade/Device Name: Simidur KF Plus Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJS Dated: January 18, 2002 Received: January 22, 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 (1 11 ), it and 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.
2
Page 2 – Dr. Gerhard Polzer
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. 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,
[signature]
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Page 1 of 1
1/020194 510(k) Number (if known):_
Simidur KF plus Device Name:
Indications For Use:
Simidur KF plus is a palladium-base ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients.
It is intended for manufacturing
- Crowns .
- Short span bridges .
- Long span bridges .
- Removable partials .
and can be used for
- . Telescopic and milling work
Simidur KF plus can be veneered with suitable dental ceramics as well as with dentalcomposites.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Intention Course | |
| and General Hospital D. | |
| 510(k) Number: | K020194 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| --------------------------------------- | ------------------------------------------ | ---------------------- |
(Optional Formal 1-2-96)