Apollo, Model 1124525
FDA 510(k) K020949 · Sterngold
510(k) numberK020949
Submission
- Device name
- Apollo, Model 1124525
- Applicant
- Sterngold
Attleboro, MA, US - Received
- March 25, 2002
- Decision date
- April 4, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K052463 | Prometal HN86EJT · Traditional | Prometal Technologies | 10/14/2005SE |
| K041378 | Bio 60EJT · Traditional | Kodent, Inc. | 08/02/2004SE |
| K040672 | Porta ReflexEJT · Traditional | Wieland Dental + Technik GmbH & Co. KG | 05/27/2004SE |
| K040524 | Porta Solder 1090 WEJT · Traditional | Wieland Dental + Technik GmbH & Co. KG | 05/20/2004SE |
| K040043 | NDX-40 AlloyEJT · Traditional | Heraeus Kulzer, Inc. | 03/03/2004SE |
| K034049 | Herador Ec, PF, C, H, NH, G, GG and MP; Heraloy U and G; Herabond N; Albabond C, B and…EJT · Traditional | Heraeus Kulzer,GmbH | 03/01/2004SE |
| K033279 | Gold Dental Casting AlloysEJT · Traditional | Bego U.S.A. | 01/15/2004SE |
| K033446 | APEX93, APEX87, APEX84, APEX85, APEX77, E-Sarang 88 and E-Sarang 82EJT · Traditional | We Dong Myung Dental Industrial Co., Ltd. | 11/13/2003SE |
| K033435 | E-Sarang 86, DM78, DM55EJT · Traditional | We Dong Myung Dental Industrial Co., Ltd. | 11/12/2003SE |
| K032320 | Appollo 3 AlloyEJT · Traditional | Dentsply International | 10/01/2003SE |
More from Dentsply International
| 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 |
| K021367 | Sterngold 66, Model #1180230EJS · Abbreviated | 05/16/2002SE |
| 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 Apollo, Model 1124525 cleared by the FDA?
Apollo, Model 1124525 (K020949) received a 510(k) decision of Substantially Equivalent on April 4, 2002, 10 days after the submission was received.
What is the product code of K020949?
The FDA product code is EJT – Alloy, Gold-Based Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.