Sterngold 66, Model #1180230
FDA 510(k) K021367 · Sterngold
510(k) numberK021367
Submission
- Device name
- Sterngold 66, Model #1180230
- Applicant
- Sterngold
Attleboro, MA, US - Received
- April 30, 2002
- Decision date
- May 16, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EJS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K041433 | Bright Gold XHEJS · Traditional | Ivoclar Vivadent, Inc. | 08/19/2004SE |
| 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 |
| 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 |
| K014082 | D.Sign 53, Model NA1012204EJS · Traditional | Ivoclar Vivadent, Inc. | 01/30/2002SE |
More from Ivoclar Vivadent, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K092434 | Sterngold 2.2MM Angles Micro Era Dental Implant SystemDZE · Abbreviated | 11/10/2009SE |
| K041271 | Sterngold 3.25 Era Dental Implant SystemDZE · Abbreviated | 10/28/2004SE |
| K023580 | Sterngold Acid Etch Dental Implant SystemDZE · Abbreviated | 01/17/2003SE |
| K022252 | Sterngold 1, Model 1127781EJS · Abbreviated | 09/19/2002SE |
| K021741 | Critertion, Model #1067511EJT · Abbreviated | 06/26/2002SE |
| K021045 | Era ImplantDZE · Abbreviated | 06/26/2002SE |
| K020949 | Apollo, Model 1124525EJT · Abbreviated | 04/04/2002SE |
| K020391 | Stern Micro Era Attachment SystemDZE · Special | 03/08/2002SE |
| K003007 | GalaxyEJT · Abbreviated | 11/17/2000SE |
| K991436 | Sterngold Implamed Narrow Platform Dental Implants and Related Prosthetics and…DZE · Special | 05/07/1999SE |
Questions and answers
When was Sterngold 66, Model #1180230 cleared by the FDA?
Sterngold 66, Model #1180230 (K021367) received a 510(k) decision of Substantially Equivalent on May 16, 2002, 16 days after the submission was received.
What is the product code of K021367?
The FDA product code is EJS – Alloy, Other Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.