# K031627: Nano-Ticrown

- Pathway: 510(k) (Traditional)
- Applicant: Nano-Write Corp.
- Decided: Jun 11, 2003 after 15 days
- Product code: EJH (Alloy, Metal, Base)
- Device class: 2
- Regulation: 21 CFR 872.3710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K901552 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901552: (CP) Titanium and TI6AI-4V Alloy for Fixed Prosthe, Nobelpharma USA, Inc. (1991) Summary page 2.
- K001798: DC Titan, Austenal, Inc. (2000)

## Indications for use
This device entitled: Nano-TiCrown TM Titanium Metal Alloy Dental Device (aka: Nano-TiCrown TM ) is a Titaniumflitanium Nitride based alloy intended for use as a base metal alloy in the making of single uoit device porcelain-fused-to-metal (PFM) prosthetic dental materials and custom-made dental prosthetic devices, such as a porcelain-to-metalveneer for a tooth. The Nano-TiCrown is intended to be used as a single unit coping device, i.e., a PFM dental restorative device, and this device is not intended for use on metal only or other non-cerarnic porcelain restorations. Nano-TiCrown is a Class I1(non-exempt) medical device that is described within the Dental Products medical specialty panel of the U.S. Food and Drug Administration (FDA), under FDA Regulation Number 21 CFR 872.3710, and Product Code: EJH. The Nano-TiCrown TM device is recommended for all anterior and posterior tooth dental crown restorations. This Titaniumnitanium Nitride coping device (Le., Nano-TiCrownTM)is to be used by dental laboratories in the fabrication of PFM dental crowns for dentists. This Nano-TiCrown TM is intended to be marketed to medical professionals and for point-of-care use, and is not intended for sale over-the-counter in its current design. [Warning: This device should be used with caution where the patient has known metal allergies and specifically is not intended to be used where known patient allergies to Titanium exist]

Source page: https://510kreport.com/device/K031627
Methodology: https://510kreport.com/methodology