# K162677: L- OVC

- Pathway: 510(k) (Traditional)
- Applicant: Rhondium, Ltd.
- Decided: Dec 21, 2016 after 86 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K910611 (1991). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143694: Rhondium One-Visit-Crown (OVC), Rhondium, Ltd. (2015) Summary page 4.
- K100512: Nobelprocera Ips E.Max Crown, Nobel Biocare AB (2010) Summary page 4.
- K090826: Monobond Plus, Ivoclar Vivadent, Inc. (2009) Summary page 4.
- K123397: Multilink Automix, Ivoclar Vivadent, AG (2013) Summary page 4.

## Indications for use
L-OVC is intended for restoration of permanent teeth with a single unit crown.

Source page: https://510kreport.com/device/K162677
Methodology: https://510kreport.com/methodology