Nano-Ticrown
FDA 510(k) K031627 · Nano-Write Corp.
510(k) numberK031627
Submission
- Device name
- Nano-Ticrown
- Applicant
- Nano-Write Corp.
Livermore, CA, US - Received
- May 27, 2003
- Decision date
- June 11, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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|---|---|---|---|
| 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 |
| 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 |
Questions and answers
When was Nano-Ticrown cleared by the FDA?
Nano-Ticrown (K031627) received a 510(k) decision of Substantially Equivalent on June 11, 2003, 15 days after the submission was received.
What is the product code of K031627?
The FDA product code is EJH – Alloy, Metal, Base, a Class II (moderate risk) device regulated under 21 CFR 872.3710.