R & D Designation AP-047
FDA 510(k) K010611 · Jensen Industries, Inc.
510(k) numberK010611
Submission
- Device name
- R & D Designation AP-047
- Applicant
- Jensen Industries, Inc.
North Haven, CT, US - Received
- March 1, 2001
- Decision date
- March 27, 2001
- 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 |
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| 510(k) | Device | Decision |
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| K142043 | Insync ZR High Translucency ZirconiaEIH · Abbreviated | 12/18/2014SE |
| K112806 | Jensen ZirconiaEIH · Abbreviated | 12/01/2011SE |
| K111743 | The Insync Ceramic SystemEIH · Abbreviated | 09/14/2011SE |
| K070114 | Creation Cp-Zi PorcelainEIH · Abbreviated | 03/01/2007SE |
| K050838 | The Lf-P Ceramic SystemEIH · Abbreviated | 05/04/2005SE |
| K043201 | Willi Geller Creation Zi PorcelainEIH · Abbreviated | 01/11/2005SE |
| K043221 | Willi Geller Creation CP PorcelainEIH · Traditional | 12/20/2004SE |
| K032267 | R&D Designation AP-052-5EJT · Traditional | 09/17/2003SE |
| K022206 | Jensen Gold FoilEJT · Traditional | 08/29/2002SE |
Questions and answers
When was R & D Designation AP-047 cleared by the FDA?
R & D Designation AP-047 (K010611) received a 510(k) decision of Substantially Equivalent on March 27, 2001, 26 days after the submission was received.
What is the product code of K010611?
The FDA product code is EJT – Alloy, Gold-Based Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.