Argebond 80
FDA 510(k) K913704 · Argen Precious Metals, Inc.
510(k) numberK913704
Submission
- Device name
- Argebond 80
- Applicant
- Argen Precious Metals, Inc.
San Diego, CA, US - Received
- August 19, 1991
- Decision date
- November 13, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K040436 | Simidur SuperiorEJS · Traditional | Wieland Dental + Technik GmbH & Co. KG | 03/05/2004SE |
| K022252 | Sterngold 1, Model 1127781EJS · Abbreviated | Sterngold | 09/19/2002SE |
| K022469 | Eco E4EJS · Traditional | Wieland Dental + Technik GmbH & Co. KG | 09/18/2002SE |
| K021367 | Sterngold 66, Model #1180230EJS · Abbreviated | Sterngold | 05/16/2002SE |
| K020195 | Simidur S1SEJS · Traditional | Wieland Dental + Technik GmbH & Co. KG | 03/15/2002SE |
| K020194 | Simidur KF PlusEJS · Traditional | Wieland Dental + Technik GmbH & Co. KG | 03/15/2002SE |
| K020192 | Simidur S2EJS · Traditional | Wieland Dental + Technik GmbH & Co. KG | 03/15/2002SE |
| K014042 | D.Sign 84EJS · Traditional | Ivoclar Vivadent, Inc. | 02/22/2002SE |
| K013809 | D.Sign 59EJS · Traditional | Ivoclar Vivadent, Inc. | 02/07/2002SE |
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| K961211 | Argelite 52+EJT · Traditional | 04/25/1996SE |
| K961285 | Argedent 40(GOLD-PALLADIUM-SILVER Alloy for Porcelain Application)EJT · Traditional | 04/18/1996SE |
| K954362 | Argistar 74EJT · Traditional | 10/12/1995SE |
| K954404 | Aurolite 45EJT · Traditional | 10/07/1995SE |
| K954371 | Surefire SEJT · Traditional | 10/07/1995SE |
| K954368 | Argedent Bio 87 PFEJT · Traditional | 10/07/1995SE |
| K954367 | Argistar Bio 75PFEJT · Traditional | 10/07/1995SE |
| K954361 | Argenco 68MEJT · Traditional | 10/07/1995SE |
Questions and answers
When was Argebond 80 cleared by the FDA?
Argebond 80 (K913704) received a 510(k) decision of Substantially Equivalent on November 13, 1991, 86 days after the submission was received.
What is the product code of K913704?
The FDA product code is EJS – Alloy, Other Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.