(15 days)
Simidur Superior is a palladium - silver 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 Superior can be veneered with suitable dental ceramics as well as with dentalcomposites.
SIMIDUR SUPERIOR is a palladium-silver ceramic alloy with high contents of precious metals (87,0%), intended for dental technicians to fabricate dental restorations.
It has an indication for use which ranges from single crowns up to long span bridges with two or more pontics. In addition, it can be used for removable partials as well as for telescopic and milling work.
SIMIDUR SUPERIOR is highly corrosion resistant and has aan 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 SUPERIOR can be veneered with suitable dental ceramics and with dental composites.
I am unable to extract specific acceptance criteria for the device performance from the provided text. The document is a 510(k) summary for a dental alloy, Simidur Superior, and primarily focuses on its substantial equivalence to a predicate device and its compliance with general regulations and standards.
The text states:
- "SIMIDUR SUPERIOR 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."
However, it does not provide:
- A table of specific acceptance criteria (e.g., minimum tensile strength, maximum corrosion rate, specific biocompatibility test results with acceptance thresholds).
- Any details of a specific study or test results that "prove the device meets the acceptance criteria." The mention of compliance to ISO 9693 implies testing was done, but the results and methodologies are not described in this document.
Therefore, I cannot provide the requested table or details about a study, sample sizes, ground truth, experts, adjudication, or MRMC/standalone studies. This 510(k) summary is a declaration of compliance rather than a detailed report of performance testing.
{0}------------------------------------------------
MAR - 5 2004
Premarket Notification 510(k)
Simidur Superior
5. 510 (k) Summary
| 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 |
Date of Summary: 2004-02-16
SIMIDUR SUPERIOR Trade name:
I'M A
WINNER
Alloy, precious metal, for clinical use Classification name: Product code: ETS 872.3060 C.D.R section: Classification: Class II
Legally marketed Superior (Jensen Industries) equivalent device: Not known 510(k) number:
Device description
SIMIDUR SUPERIOR is a palladium-silver ceramic alloy with high contents of precious metals (87,0%), intended for dental technicians to fabricate dental restorations.
It has an indication for use which ranges from single crowns up to long span bridges with two or more pontics. In addition, it can be used for removable partials as well as for telescopic and milling work.
is highly corrosion resistant and has aan excellent SIMIDUR SUPERIOR 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 SUPERIOR can be veneered with suitable dental ceramics and with dental composites.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is facing to the right and has three wavy lines extending from its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 5 2004
Gerhard Polzer, Ph.D. Director, Regulatory Affairs Wieland Dental + Technik GmbH & Co. KG Schwenninger Strasse 13 D-75179 Pforzheim GERMANY
Re: K040436
Trade/Device Name: Simidur Superior Regulation Number: 21 CFR 872.3060 Regulation Namc: Gold Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Codes: EJS Dated: February 16, 2004 Received: February 19, 2004
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 controls provisions of 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 Mr), it may be bacyer in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roublish 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 Please be advised that PDA 3 issualled of a basical complies with other requirements mean that FDA has made a decornmanen untily Job administered by other Federal agencies. of the Act of ally receitar statutes and reguirements, including, but not limited to: registration You must comply with an the Fiel one (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807), laceling (2) CFR Part 800) regulation (21 CFR Part 820); and if requirements as set form in the quality systems (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) This letter will anow you to oegal mading of substantial equivalence of your device to a premiarket notification. THE FDF Intellige of coassification 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), If you desire specific advice for your do 10 304-4613. Additionally, for questions on please contact the Office of Comphanes at (2 s) .
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 (201) 594-4059. AISO, picaso note in regaranten comments obtain. Other general information on
premarket notification" (21CFR Part 807.97) you may obtain. Other general inf premarket nothreation (21 CF F F I via be obtained from the Division of Small your responsibilities ander also rece one as 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 vours,
Clarks
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
{3}------------------------------------------------
| Page | 1 |
|---|---|
| of | 1 |
:
.
| 510 (k) NUMBER (IF KNOWN) : | K040436 |
|---|---|
| DEVICE NAME: | Simidur Superior |
INDICATIONS FOR USE:
Simidur Superior is a palladium - silver ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients.
It is intended for manufacturing
- . Crowns
.
1
- Short span bridges a
- . Long span bridges
- Removable partials .
and can be used for
- . Telescopic and milling work
Simidur Superior 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)
| Prescription Use | ✓ | OR | Over-The-Counter-Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number | K040436 |
|---|---|
| --------------- | --------- |
§ 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.