Ultracrown(Tm) PD Alloy Post-Solder
FDA 510(k) K913860 · Dentsply Intl.
510(k) numberK913860
Submission
- Device name
- Ultracrown(Tm) PD Alloy Post-Solder
- Applicant
- Dentsply Intl.
York, PA, US - Received
- August 27, 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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| 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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Questions and answers
When was Ultracrown(Tm) PD Alloy Post-Solder cleared by the FDA?
Ultracrown(Tm) PD Alloy Post-Solder (K913860) received a 510(k) decision of Substantially Equivalent on November 13, 1991, 78 days after the submission was received.
What is the product code of K913860?
The FDA product code is EJS – Alloy, Other Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.