(47 days)
K 925973
Not Found
No
The device description is for a dental solder, a material used for joining dental alloy parts. There is no mention of software, algorithms, or any technology that would incorporate AI or ML.
No
The device is a dental brazing alloy used to join dental alloy parts, not to directly treat or diagnose a disease or condition in a patient.
No
Explanation: This device is a dental brazing alloy (solder) used to join dental alloy parts to form a dental restoration. It is a material used in the fabrication of a dental appliance, not a device that diagnoses a condition or disease.
No
The device description clearly states it is a "dental brazing alloy" and a "yellow alloy with high contents of precious metals," indicating it 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 join dental alloy parts to form a dental restoration (like bridges). This is a manufacturing process for a medical device that will be placed in the patient's mouth.
- Device Description: It's described as a "dental brazing alloy" and "filler material" used by dental technicians to fabricate dental appliances.
- Lack of Diagnostic Purpose: There is no mention of this 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 test samples like blood, urine, or tissue to diagnose or monitor a medical condition. This device is a material used in the creation of a dental prosthesis.
N/A
Intended Use / Indications for Use
Porta OP Solder M-1 is intended for use as a primary solder in operations in which dental alloy(s) parts are joined to form a dental restoration.
It should be used only together with recommended dental alloys with suitable melting ranges and compositions.
Product codes (comma separated list FDA assigned to the subject device)
EJT
Device Description
Porta OP Solder M-1 is a dental brazing alloy, that can be used by dental technicians to fabricate dental appliances for patients. It is a yellow alloy with high contents of precious metals (Gold, Platinum and Silver: 90,0%).
Porta OP Solder M-1 is suitable for use as a filler material in operations in which dental alloy(s) parts are joined to form a dental restoration, e.g. bridges.
It is intended as primary solder for dental casting alloys with appropriate melting ranges and compositions, especially BioPortadur, Portadur P 2, Auropal 1, Auropal 60, and Auropal 50, which are manufactured by Wieland Dental + Technik GmbH & Co. KG, Germany.
Porta OP Solder M-1 is highly corrosion resistant. It fully complies to the international standard ISO 9333 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): 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 925973
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
Premarket Notification 510(k)
Porta OP Solder M-1
5. 510 (k) Summary
K02452
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: 2002-06-18
PORTA OP SOLDER M-1 Trade name:
Classification name: Alloy, gold based, for clinical use Product code: EJT 872.3060 C.D.R section: Class II Classification:
Legally marketed Vacu-PF equivalent device: 510(k) number: K 925973
Device description
Porta OP Solder M-1 is a dental brazing alloy, that can be used by dental technicians to fabricate dental appliances for patients. It is a yellow alloy with high contents of precious metals (Gold, Platinum and Silver: 90,0%).
Porta OP Solder M-1 is suitable for use as a filler material in operations in which dental alloy(s) parts are joined to form a dental restoration, e.g. bridges.
It is intended as primary solder for dental casting alloys with appropriate melting ranges and compositions, especially BioPortadur, Portadur P 2, Auropal 1, Auropal 60, and Auropal 50, which are manufactured by Wieland Dental + Technik GmbH & Co. KG, Germany.
Porta OP Solder M-1 is highly corrosion resistant. It fully complies to the international standard ISO 9333 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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 1 2002
Dr. Gerhard Polzer Director, Regulatory Affairs Wieland Dental + Technik GmbH & Company KG Schwenninger Straße 13 D-75179 Pforzheim GERMANY
Re: K022452
Trade/Device Name: Porta OP Solder M-1 Regulation Number: 21 CFR 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: July 22, 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.
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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
Timothy Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
一
510(k) Number (if known) Porta OP Solder M-1
Device Name:_
Indications For Use:
Porta OP Solder M-1 is intended for use as a primary solder in operations in which dental alloy(s) parts are joined to form a dental restoration.
lt should be used only together with recommended dental alloys with suitable melting ranges and compositions.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | Over-The-Counter Use | |
|---|---|---|---|
| ------------------ | --- | -- | ---------------------- |
(Per 21 CFR 801.109)
| Susan Rikin | |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital, (Optional Format 1-2-96) | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K033452 |