# K993223: Rapicure 200 (Curing and Whitening Light)

- Pathway: 510(k) (Traditional)
- Applicant: Mediphotonix, LC
- Decided: Nov 1, 1999 after 35 days
- Product code: EBZ (Activator, Ultraviolet, For Polymerization)
- Device class: 2
- Regulation: 21 CFR 872.6070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K951425 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952333: Plasma Arc Curing System, American Dental Technologies, Inc. (1995) Summary page 1.
- K981948: Apollo 95E, Dental/Medical Diagnostic Systems, Inc. (1998) Summary page 1.
- K982615: Airdent Radiance Curing Light, Air Techniques, Inc. (1998) Summary page 1.
- K982318: Spectrum 800 Curing Unit, Dentsply Intl. (1998) Summary page 1.
- K980792: CU-100A Light Cure Unit, Rolence Enterprise Co., Ltd. (1998) Summary page 1.
- K980793: Q-Luxpro V/Q-Luxpro II Light Cure Unit, Rolence Enterprise Co., Ltd. (1998) Summary page 1.

## Indications for use
This device is intended for use: 1. As a source of illumination for curing dental restorative materials, 2. Assisting in the whitening process in a dental office.

Source page: https://510kreport.com/device/K993223
Methodology: https://510kreport.com/methodology