Aurofilm NP
FDA 510(k) K003387 · Metalor Dental USA Corp.
510(k) numberK003387
Submission
- Device name
- Aurofilm NP
- Applicant
- Metalor Dental USA Corp.
North Attleborough, MA, US - Received
- October 31, 2000
- Decision date
- January 9, 2001
- 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 |
|---|---|---|
| K993475 | Aurofluid M, Alloy No. 5315EJS · Traditional | 12/09/1999SE |
| K993506 | Pagalinor 4 , Alloy No. 5440EJS · Traditional | 12/08/1999SE |
| K993505 | V-Delta Special, Alloy No. 5154EJS · Traditional | 12/08/1999SE |
| K993508 | V-Supra Plus, Alloy No. 5025EJT · Traditional | 12/06/1999SE |
| K993507 | V-Supragold, Alloy No. 5024EJT · Traditional | 12/06/1999SE |
| K993474 | Deltapal, Alloy No. 5161EJS · Traditional | 12/02/1999SE |
| K982606 | Aurofluid CPFEJT · Traditional | 10/15/1998SE |
| K973372 | Aurofilm 2000EJT · Traditional | 11/26/1997SE |
| K972683 | V-Delta 450EJS · Traditional | 08/18/1997SE |
| K970045 | Solaro 33EJS · Traditional | 03/05/1997SE |
Questions and answers
When was Aurofilm NP cleared by the FDA?
Aurofilm NP (K003387) received a 510(k) decision of Substantially Equivalent on January 9, 2001, 70 days after the submission was received.
What is the product code of K003387?
The FDA product code is EJH – Alloy, Metal, Base, a Class II (moderate risk) device regulated under 21 CFR 872.3710.