Biosil F
FDA 510(k) K861820 · Degussa Dental, Inc.
510(k) numberK861820
Submission
- Device name
- Biosil F
- Applicant
- Degussa Dental, Inc.
Long Island, NY, US - Received
- May 12, 1986
- Decision date
- June 13, 1986
- 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 |
|---|---|---|
| K883758 | Albabond 60EJT · Traditional | 10/12/1988SE |
| K883511 | Albabond EEJS · Traditional | 10/06/1988SE |
| K883509 | Heraeus DG 63EJS · Traditional | 09/22/1988SE |
| K883508 | Hera HEJT · Traditional | 09/22/1988SE |
| K883510 | Degupal 4EJS · Traditional | 09/15/1988SE |
| K883507 | Heraeus C SpecialEJS · Traditional | 09/15/1988SE |
| K883512 | Heraeus WhiteEJS · Traditional | 09/06/1988SE |
| K883036 | Palliag NF IIIEJT · Traditional | 08/12/1988SE |
| K880033 | DegustarEJT · Traditional | 03/07/1988SE |
| K871808 | Duceram-Metal-Ceramic Dental Porcelain SystemELL · Traditional | 06/05/1987SE |
Questions and answers
When was Biosil F cleared by the FDA?
Biosil F (K861820) received a 510(k) decision of Substantially Equivalent on June 13, 1986, 32 days after the submission was received.
What is the product code of K861820?
The FDA product code is EJH – Alloy, Metal, Base, a Class II (moderate risk) device regulated under 21 CFR 872.3710.