(15 days)
Not Known
Not Found
No
The 510(k) summary describes a dental alloy material and its intended uses in fabricating dental appliances. There is no mention of software, algorithms, or any technology that would incorporate AI or ML.
No.
The device is a palladium-silver ceramic alloy used by dental technicians to fabricate dental appliances, not a therapeutic device itself.
No
Explanation: The device is a dental alloy used to fabricate dental appliances. It does not perform any diagnostic function.
No
The device description clearly states it is a palladium-silver ceramic alloy, which is a physical material used for fabricating dental appliances, 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 (crowns, bridges, partials) for patients. This is a direct application within the body or for use in the mouth, not for testing samples taken from the body.
- Device Description: The description confirms it's a dental alloy used to create restorations.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the body (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information.
This device falls under the category of a dental material used to create medical devices (the dental appliances themselves).
N/A
Intended Use / 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
- 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.
Product codes (comma separated list FDA assigned to the subject device)
ETS, EJS
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.
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.
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.
Not Known
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
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
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| 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 |
|---|---|
| --------------- | --------- |