Wirobond C
FDA 510(k) K032136 · Bego U.S.A.
510(k) numberK032136
Submission
- Device name
- Wirobond C
- Applicant
- Bego U.S.A.
Lincoln, RI, US - Received
- July 11, 2003
- Decision date
- September 4, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K024214 | Kavo Everest TitanblankEJH · Traditional | Kavo America | 03/12/2003SE |
More from Kavo America
| 510(k) | Device | Decision |
|---|---|---|
| K033279 | Gold Dental Casting AlloysEJT · Traditional | 01/15/2004SE |
| K983082 | Begocer GEJT · Traditional | 10/28/1998SE |
| K983080 | Aurolloyd KFEJT · Traditional | 10/28/1998SE |
| K983079 | Platinlloyd 100EJT · Traditional | 10/23/1998SE |
| K983078 | BegopalEJS · Traditional | 10/23/1998SE |
| K983077 | Bio PontostarEJT · Traditional | 10/23/1998SE |
Questions and answers
When was Wirobond C cleared by the FDA?
Wirobond C (K032136) received a 510(k) decision of Substantially Equivalent on September 4, 2003, 55 days after the submission was received.
What is the product code of K032136?
The FDA product code is EJH – Alloy, Metal, Base, a Class II (moderate risk) device regulated under 21 CFR 872.3710.