510(k) · Cleared
ClearedNano-Ticrown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nano-Write Corp. · EJH Alloy, Metal, Base
Cleared on Jun 11, 2003 as substantially equivalent to K901552 (Nobelpharma USA, Inc., 1991) and 1 other predicate after a 15-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Jun 11, 2003
- Review
- 15 days
- Class
- Class II
- Product code
- EJH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K901552 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK901552 (CP) Titanium and TI6AI-4V Alloy for Fixed ProstheNobelpharma USA, Inc. · 1991
- This deviceK031627 Nano-TicrownNano-Write Corp. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K901552 | (CP) Titanium and TI6AI-4V Alloy for Fixed Prosthe | Nobelpharma USA, Inc. | 1991 | — |
| 0 (this device) | K031627 | Nano-Ticrown | Nano-Write Corp. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EJH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All EJH devicesEJH Alloy, Metal, Base: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EJH
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · EJH
Too few EJH 510(k)s in any year since 2007 to give a median.
Recalls per year · EJH
No recall names EJH since 2007.
Adverse event reports per year · EJH
1in 2018
MAUDE reports naming product code EJH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (216 words)
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]
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031627 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031627: Nano-Ticrown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031627
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026