# K143694: Rhondium One-Visit-Crown (OVC)

- Pathway: 510(k) (Traditional)
- Applicant: Rhondium, Ltd.
- Decided: May 15, 2015 after 142 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K910860 (1991). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072733: 3M Espe Adult Crown, 3M Company (2008) Summary page 6.
- K050401: Ceramage, Shofu Dental Corp. (2005) Summary page 6.
- K052501: Multiple Resin Tooth Bonding Agent, Cosmedent, Inc. (2005) Summary page 6.
- K092319: Star VPS, Model 80014-01, First Quater, Model 90649, First Half, Model 89387, Danville Materials, Inc. (2009) Summary page 6.

## Most influential descendants
- K172952: Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit (2018), 0 descendants of its own
- K162677: L- OVC (2016), 0 descendants of its own

## Recalls of this device
- Jan 31, 2019 · Class II · Z-0708-2020: The product was mislabeled with an incorrect expiration date.

## Indications for use
Rhondium One-Visit-Crown is intended for restoration of permanent teeth with a single unit crown.

Source page: https://510kreport.com/device/K143694
Methodology: https://510kreport.com/methodology