(52 days)
K 901098
Not Found
No
The device description focuses on the material composition and intended use of a dental alloy, with no mention of AI or ML technologies.
No
The device is an alloy used to fabricate dental appliances, not a device that directly provides therapy or treatment to a patient.
No
Explanation: The device is a palladium-base ceramic alloy used by dental technicians to fabricate dental appliances. It is a material for manufacturing, not a tool for diagnosing 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 (crowns, bridges, partials, etc.). This is a medical device used in the treatment of patients, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description focuses on the material properties and its use in creating dental restorations. It mentions biocompatibility and compliance with medical device directives, further supporting its classification as a medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, Simidur S2 is a medical device, specifically a dental alloy used for fabricating restorations, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Simidur S2 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 S2 can be veneered with suitable dental ceramics as well as with dentalcomposites.
Product codes
EJS
Device Description
Simidur S2 is a palladium-base ceramic alloy with a high content of noble metals (81% ), intended for dental technicians to fabricate dental restorations. lt has an indication which ranges from single crowns up to long span bridges with two it has an indication which farges wortials. It is free of silver and suitable for telescopic and milling work. Simidur S2 is highly corrosion resistant and has an excellent biocompatibility. It fully Simidal U2 is highly ochooled ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices. Simidur S2 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)
K 901098
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
K,020)92
MAR 1 5 2002,
Premarket Notification 510(k)
Simidur S2
5. 510 (k) Summary
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:
Trade name:
Simidur S2
2001-12-14
Classification name: Product code: C.D.R section: Classification:
Alloy, precious metal, for clinical use ElS 872.3060 Class II
Legally marketed Spartan Plus equivalent device: K 901098 510(k) number:
Device description
Simidur S2 is a palladium-base ceramic alloy with a high content of noble metals (81% ), intended for dental technicians to fabricate dental restorations.
lt has an indication which ranges from single crowns up to long span bridges with two it has an indication which farges wortials. It is free of silver and suitable for telescopic and milling work.
Simidur S2 is highly corrosion resistant and has an excellent biocompatibility. It fully Simidal U2 is highly ochooled ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
Simidur S2 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 stylized eagle with three curved lines representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is in all capital letters and is arranged in a circular fashion to match the shape of the logo.
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: K020192
Trade/Device Name: Simidur S2 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 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.
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
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
K020192 510(k) Number (if known):_
Simidur S2 Device Name:
Indications For Use:
Simidur S2 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
(Per 21 CFR 801 109)
- Telescopic and milling work ●
Simidur S2 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, Infection Control,
and General Hospital Devices
K020192 =
Prescription Use \checkmark OR Over-The-Counter Use.....
(Optional Formal 1-2-96)