Vera PDS & Vera Pdi
FDA 510(k) K915249 · Aalba Dent, Inc.
510(k) numberK915249
Submission
- Device name
- Vera PDS & Vera Pdi
- Applicant
- Aalba Dent, Inc.
Chicago, IL, US - Received
- November 15, 1991
- Decision date
- March 2, 1992
- 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 |
| 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 |
|---|---|---|
| K040180 | Continum VEJH · Traditional | 03/04/2004SE |
| K040179 | ContinumEJH · Traditional | 03/03/2004SE |
| K033356 | Verasoft EsEJH · Traditional | 12/30/2003SE |
| K982094 | Verabond 2EJH · Traditional | 07/22/1998SE |
| K972971 | NPG + 2EJH · Traditional | 01/05/1998SE |
| K973265 | Verabond 2VEJH · Traditional | 10/16/1997SE |
| K972607 | PlatalloyEJH · Traditional | 10/10/1997SE |
| K972534 | AlfalloyEJS · Traditional | 09/05/1997SE |
| K972533 | Vera SolderEJS · Traditional | 09/05/1997SE |
| K972632 | Vera PD SolderEJT · Traditional | 08/15/1997SE |
Questions and answers
When was Vera PDS & Vera Pdi cleared by the FDA?
Vera PDS & Vera Pdi (K915249) received a 510(k) decision of Substantially Equivalent on March 2, 1992, 108 days after the submission was received.
What is the product code of K915249?
The FDA product code is EJH – Alloy, Metal, Base, a Class II (moderate risk) device regulated under 21 CFR 872.3710.