← Product Code [EJT](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJT) · K022459 # AUROPAL SOLDER M-1 (K022459) _Wieland Dental + Technik GmbH & Co. KG · EJT · Sep 12, 2002 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJT/K022459 ## Device Facts - **Applicant:** Wieland Dental + Technik GmbH & Co. KG - **Product Code:** [EJT](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJT.md) - **Decision Date:** Sep 12, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3060 - **Device Class:** Class 2 - **Review Panel:** Dental ## Indications for Use Auropal 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. ## Device Story Auropal Solder M-1 is a pale yellow, high-precious-metal (82% gold, palladium, silver) dental brazing alloy. Used by dental technicians in laboratory settings to join dental alloy components during the fabrication of restorations like bridges. Acts as a filler material; requires compatibility with specific dental alloys having matching melting ranges and compositions (e.g., ECO E4). Highly corrosion-resistant; provides structural integrity to joined dental appliances. Not for secondary soldering applications. ## Clinical Evidence Bench testing only. The device complies with international standard ISO 9333 for dental brazing alloys. ## Technological Characteristics Gold-based dental brazing alloy; 82% precious metal content (Au, Pd, Ag). Form factor: solder material. Complies with ISO 9333. Corrosion resistant. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Argesol #615 ([K942980](/device/K942980.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ### Premarket Notification 510(k) ## Auropal Solder M-1 K022459 #### 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: 2002-06-18 Trade name: AUROPAL SOLDER M-1 Classification name: Alloy, gold based, for clinical use Product code: EJT C.D.R section: 872.3060 Classification: Class II Legally marketed equivalent device: Argesol #615 510(k) number: K 942980 #### Device description Auropal Solder M-1 is a dental brazing alloy, that can be used by dental technicians to fabricate dental appliances for patients. It is a pale yellow alloy with high contents of precious metals (Gold, Palladium and Silver: 82%). Auropal 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 a primary solder for dental alloys with appropriate melting ranges and compositions, especially ECO E4, which is manufactured by Wieland Dental + Technik GmbH & Co. KG, Germany. In cases where secondary soldering is needed, Auropal Solder W-2 should be used. Auropal 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 symbol that resembles a human figure in profile, with three wavy lines extending from the head, representing the department's mission to protect the health of all Americans and provide essential human services. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # SFP 12 2002 Dr. Gerhard Polzer Director, Regulatory Affairs Wieland Dental + Technik GmbH & Company KG Schwenninger Straße 13 D-75179 Pforzheim GERMANY Re: K022459 Trade/Device Name: Auropal 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. {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.gov/cdrh/dsma/dsmamain.html Sincerely yours, Patricia Ciccotta Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Page 1 of 1 יין 510(k) Number (if known): K022459 Auropal Solder M-1 Device Name: Indications For Use: Auropal 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. (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) SRVOR SusaKuNOR Over-The-Counter Use..... (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices (Optional Format 1-2-96) 510(k) Number: K022459 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJT/K022459](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJT/K022459) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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