Vitex P.D.A
FDA 510(k) K834560 · Jeneric Ind.
510(k) numberK834560
Submission
- Device name
- Vitex P.D.A
- Applicant
- Jeneric Ind.
Mchenry, IL, US - Received
- December 28, 1983
- Decision date
- February 27, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EJH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K123929 | Begopal+EJH · Abbreviated | Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO | 03/14/2013SE |
| K040180 | Continum VEJH · Traditional | Aalba Dent, Inc. | 03/04/2004SE |
| K040179 | ContinumEJH · Traditional | Aalba Dent, Inc. | 03/03/2004SE |
| K033356 | Verasoft EsEJH · Traditional | Aalba Dent, Inc. | 12/30/2003SE |
| K033045 | Dream Bond, Dreamcast Chrome, Dreamcast V, Dream Flexicast, Dream LithecastEJH · Traditional | American Green Dent. Mfg, Inc. | 12/23/2003SE |
| K032136 | Wirobond CEJH · Traditional | Bego U.S.A. | 09/04/2003SE |
| K031627 | Nano-TicrownEJH · Traditional | Nano-Write Corp. | 06/11/2003SE |
| K030632 | PD Casta-HEJH · Traditional | Mountain Medico, Inc. | 05/07/2003SE |
| K030416 | Ceracast-VEJH · Traditional | Mountain Medico, Inc. | 04/14/2003SE |
| K030161 | SuperbondEJH · Traditional | American Dent-All, Inc. | 03/17/2003SE |
More from American Dent-All, 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 |
| K833774 | Naturelle II & Lite II-N72-N74-LEJS · Traditional | 01/24/1984SE |
| K833736 | Gold-Palladium-Silver Based Cast/AlloyEIS · Traditional | 12/29/1983SE |
Questions and answers
When was Vitex P.D.A cleared by the FDA?
Vitex P.D.A (K834560) received a 510(k) decision of Substantially Equivalent on February 27, 1984, 61 days after the submission was received.
What is the product code of K834560?
The FDA product code is EJH – Alloy, Metal, Base, a Class II (moderate risk) device regulated under 21 CFR 872.3710.