(79 days)
K 012826
Not Found
No
The summary describes a dental alloy material and its intended uses, with no mention of software, algorithms, or any technology that would incorporate AI or ML.
No
A therapeutic device is one that treats or prevents a disease. This device is a material used to fabricate dental appliances; it does not directly treat or prevent a condition.
No
The device is a gold-platinum ceramic alloy used by dental technicians to fabricate dental appliances. It is a material used in the manufacturing process, not a device used for diagnosis.
No
The device description clearly states it is a gold-platinum 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 for patients, such as inlays, crowns, bridges, etc. This is a medical device used for restoration and prosthetics within the body.
- Device Description: The description confirms it's a gold-platinum alloy used by dental technicians to create dental restorations. It focuses on material properties, biocompatibility, and compliance with standards for medical devices.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological or pathological state, or to monitor therapeutic measures.
Therefore, AGC Speziallegierung is a medical device, specifically a dental material, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
AGC Speziallegierung is a gold-platinum ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients.
It is intended for manufacturing
- Inlays/Onlays
- Crowns
- Short span bridges
- Long span bridges
- Pontics for AGC bridges
- Removable partials
and can be used for - Telescopic and milling work
AGC Speziallegierung can be veneered with suitable dental ceramics as well as with dental-composites.
Product codes (comma separated list FDA assigned to the subject device)
EJT
Device Description
AGC Speziallegierung is a gold-platinum ceramic alloy with a high content of noble metals (97,5%), intended for dental technicians to fabricate dental restorations.
It has an indication which ranges from inlays/onlays and single crowns up to long span bridges with two or more pontics and pontics for AGC bridges. In addition, it can be used for manufacturing removable partials. It is free of copper and suitable for telescopic and milling work.
AGC Speziallegierung 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.
AGC Speziallegierung can be veneered with suitable dental ceramics and with dental composites, in which the golden yellow color of the alloy provides an excellent basis for manufacturing aesthetically pleasing dental restorations.
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 012826
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
Ko20347
Premarket Notification 510(k)
AGC Speziallegierung
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: 2001-12-14
Trade name: AGC Speziallegierung
Classification name: Product code: EJT C.D.R section: Classification:
Alloy, gold based, for clinical use 872.3060 Class II
Legally marketed equivalent device: BioPorta G 510(k) number: K 012826
Device description
AGC Speziallegierung is a gold-platinum ceramic alloy with a high content of noble metals (97,5%), intended for dental technicians to fabricate dental restorations.
It has an indication which ranges from inlays/onlays and single crowns up to long span bridges with two or more pontics and pontics for AGC bridges. In addition, it can be used for manufacturing removable partials. It is free of copper and suitable for telescopic and milling work.
AGC Speziallegierung 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.
AGC Speziallegierung can be veneered with suitable dental ceramics and with dental composites, in which the golden yellow color of the alloy provides an excellent basis for manufacturing aesthetically pleasing dental restorations.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 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" around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping wing shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Gerhard Polzer Wieland Edelmetalle GmbH & Company Schwenninger Strabe 13 Pforzheim, GERMANY
Re: K020347
Trade/Device Name: AGC® Speziallegierung Regulation Number: 872.3060 Regulation Name: Alloy, Gold Based, For Clinical Use Regulatory Class: II Product Code: EJT Dated: February 1, 2002 Received: February 4, 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.
2
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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
. Ulatowski Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
NUMBER (IF KNOWN) : 510 (k)
DEVICE NAME:
AGC® Speziallegierung
INDICATIONS FOR USE:
AGC Speziallegierung is a gold-platinum ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients.
It is intended for manufacturing
• Inlays/Onlays
- · Crowns
· Short span bridges
• Long span bridges
• Pontics for AGC bridges
- · Removable partials
and can be used for
• Telescopic and milling work
AGC Speziallegierung can be veneered with suitable dental ceramics as well as with dental-composites.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use (Optional Format 1-2-96)
Susan Rumpe
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number __