510(k) · Cleared
ClearedMicroscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Miras Mirror Imaging Solutions, Ltd. · EIA Unit, Operative Dental
Cleared on Sep 21, 2004 as substantially equivalent to K000112 (Dentsply Intl., 2000) and 2 other predicates after a 77-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Sep 21, 2004
- Review
- 77 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K963778 (1996). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK963778 CDR-CamSchick Technologies, Inc. · 1996
- This deviceK041805 Microscope SystemMiras Mirror Imaging Solutions, Ltd. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963778 | CDR-Cam | Schick Technologies, Inc. | 1996 | — |
| 0 (this device) | K041805 | Microscope System | Miras Mirror Imaging Solutions, Ltd. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EIA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EIA device
- #1 K231845 Dental unit Model: Marescore 14.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K000112 | Acucam Concept IV, Models A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401 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”. | 2000 |
| * | K963778 | CDR-CamSummary page 2…Intraoral Camera System (Dentsply International, Inc.), cleared under K1000112 * The Cdr-Cam System (Schick Technologies, Inc.), cleared under K963778 • The FlexiScope Optomodul (Schoelly Fiberoptic, Gmbh), cleared under K984641 * Class I Exempt Dental Mir… | 1996 |
| * | K984641 | Flexiscope OptomodulSummary page 2…The Cdr-Cam System (Schick Technologies, Inc.), cleared under K963778 • The FlexiScope Optomodul (Schoelly Fiberoptic, Gmbh), cleared under K984641 * Class I Exempt Dental Mirror (product code EAX) Performance Standards: No performance standards have been establis… | 1999 |
| * | — | Class I Exempt Dental Mirror Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K000112.
How does its category compare?
All EIA devicesEIA Unit, Operative Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EIA
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EIA
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EIA
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EIA
47in 2025
MAUDE reports naming product code EIA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 90 | 0 | 0 |
| 2008 | 6 | 72 | 0 | 0 |
| 2009 | 3 | 109 | 0 | 0 |
| 2010 | 3 | 270 | 0 | 2 |
| 2011 | 5 | 150 | 0 | 3 |
| 2012 | 2 | — | 1 | 7 |
| 2013 | 2 | — | 1 | 6 |
| 2014 | 2 | — | 0 | 255 |
| 2015 | 7 | 214 | 0 | 452 |
| 2016 | 4 | 182 | 0 | 151 |
| 2017 | 1 | — | 0 | 64 |
| 2018 | 2 | — | 0 | 73 |
| 2019 | 2 | — | 0 | 68 |
| 2020 | 1 | — | 0 | 48 |
| 2021 | 0 | — | 0 | 49 |
| 2022 | 3 | 265 | 0 | 44 |
| 2023 | 3 | 686 | 0 | 53 |
| 2024 | 3 | 251 | 0 | 53 |
| 2025 | 7 | 178 | 0 | 47 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The MirroScopeTM System is indicated for use during dental examinations and procedures when a video image is desired.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041805 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041805: Microscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041805
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026