# K991011: Orascope

- Pathway: 510(k) (Traditional)
- Applicant: Fiberdent Corp.
- Decided: Jun 23, 1999 after 89 days
- Product code: EIA (Unit, Operative Dental)
- Device class: 1
- Regulation: 21 CFR 872.6640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K933671 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980474: Telicam, Dental/Medical Diagnostic Systems, Inc. (1998) Summary page 1.
- K933671: Ultracam, Dental Vision Direct, Inc. (1994) Summary page 1.

## Most influential descendants
- K093785: Modular Endoscope (2010), 0 descendants of its own

## Indications for use
The FiberDent Corporation Orascope™ is a non diagnostic fiberoptic visualization device used to illuminate and magnify dental surfaces.

Source page: https://510kreport.com/device/K991011
Methodology: https://510kreport.com/methodology