# K981948: Apollo 95E

- Pathway: 510(k) (Traditional)
- Applicant: Dental/Medical Diagnostic Systems, Inc.
- Decided: Aug 18, 1998 after 76 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K993223: Rapicure 200 (Curing and Whitening Light) (1999), 0 descendants of its own
- K992102: Luma Light 2000 Cure Light (1999), 0 descendants of its own

## Indications for use
The Apollo 95E produces visible light for the polymerization of dental materials and for tooth whitening.

Source page: https://510kreport.com/device/K981948
Methodology: https://510kreport.com/methodology