# K041805: Microscope System

- Pathway: 510(k) (Traditional)
- Applicant: Miras Mirror Imaging Solutions, Ltd.
- Decided: Sep 21, 2004 after 77 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 K963778 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000112: Acucam Concept IV, Models A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401, Dentsply Intl. (2000). Our reading of the summary gave K100112, FDA’s number for Somona CWG Clavicle Fracture Repair Device Model Sonoma… (Sonoma Orthopedic Products, Inc.), decided Sep 28, 2010, after this device. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “AcuCam Concept IV Intraoral Camera System”. Summary page 2.
- K963778: CDR-Cam, Schick Technologies, Inc. (1996) Summary page 2.
- K984641: Flexiscope Optomodul, Schoelly Fiberoptic GmbH (1999) Summary page 2.
- (no number) Class I Exempt Dental Mirror: named in the summary without a submission number

## Indications for use
The MirroScopeTM System is indicated for use during dental examinations and procedures when a video image is desired.

Source page: https://510kreport.com/device/K041805
Methodology: https://510kreport.com/methodology