510(k) · Cleared
ClearedIntra Oral Camera System and Accessories, Model Claris I310
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sota Precision Optics, Inc. · EIA Unit, Operative Dental
Cleared on Aug 25, 2003 as substantially equivalent to K981663 (Digital Doc, LLC, 1998) after a 27-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.
- Decided
- Aug 25, 2003
- Review
- 27 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981663 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK981663 Digital DocDigital Doc, LLC · 1998
- This deviceK032341 Intra Oral Camera System and Accessories, Model Claris I310Sota Precision Optics, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK061175 Claris I310D Intraoral Camera System & AccessoriesSota Precision Optics, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K061175Claris I310D Intraoral Camera System & AccessoriesSota Precision Optics, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981663 | Digital Doc | Digital Doc, LLC | 1998 | — |
| 0 (this device) | K032341 | Intra Oral Camera System and Accessories, Model Claris I310 | Sota Precision Optics, Inc. | 2003 | — |
| +1 | K061175 | Claris I310D Intraoral Camera System & Accessories | Sota Precision Optics, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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? (1)
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 |
|---|---|---|---|
| * | K981663 | Digital DocSummary page 1…e Classification Name: Unit, Operative, Dental 10Substantial Equivalency is claimed against the following device: DIGITAL DOC from Digital Doc, Inc. 510k # K981663 11-Description Of the Device: (FW technicat ~pscificatiom,refer to the user m a n 4 1 (Full listlng and photos of accessories i… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061175 | Claris I310D Intraoral Camera System & Accessories | 2006 | 0 |
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?
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?
Claris i310 intra oral camera system and accessories is indicated for use to provide the dentist and the patient with a view of the mouth before and after the dental procedure, which assists the dentist in describing the dental procedure being performed as well as showing the results
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032341 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032341: Intra Oral Camera System and Accessories, Model Claris I310.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032341
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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