Naturelle II & Lite II-N72-N74-L
FDA 510(k) K833774 · Jeneric Ind.
510(k) numberK833774
Submission
- Device name
- Naturelle II & Lite II-N72-N74-L
- Applicant
- Jeneric Ind.
Mchenry, IL, US - Received
- October 27, 1983
- Decision date
- January 24, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Ivoclar Vivadent, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K862822 | Rexillium N. B. F.EJH · Traditional | 09/02/1986SE |
| K862926 | Surgical VitexELE · Traditional | 08/29/1986SE |
| K854878 | H40 Base Metal AlloyEJH · Traditional | 01/30/1986SE |
| K844123 | RX CbyEJH · Traditional | 01/09/1985SE |
| K844122 | RX CBGEJH · Traditional | 01/09/1985SE |
| K840563 | RX C & B 20EJS · Traditional | 05/01/1984SE |
| K840561 | RX ElanEJS · Traditional | 05/01/1984SE |
| K840562 | Rex VEJH · Traditional | 04/13/1984SE |
| K834560 | Vitex P.D.AEJH · Traditional | 02/27/1984SE |
| K833736 | Gold-Palladium-Silver Based Cast/AlloyEIS · Traditional | 12/29/1983SE |
Questions and answers
When was Naturelle II & Lite II-N72-N74-L cleared by the FDA?
Naturelle II & Lite II-N72-N74-L (K833774) received a 510(k) decision of Substantially Equivalent on January 24, 1984, 89 days after the submission was received.
What is the product code of K833774?
The FDA product code is EJS – Alloy, Other Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.