510(k) · Cleared
ClearedDigital Doc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Digital Doc, LLC · EIA Unit, Operative Dental
Cleared on Aug 10, 1998 after a 91-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Aug 10, 1998
- Review
- 91 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK981663 Digital DocDigital Doc, LLC · 1998
- Descendant · cites it directly · 1 of its ownK032341 Intra Oral Camera System and Accessories, Model Claris I310Sota Precision Optics, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK061175 Claris I310D Intraoral Camera System & AccessoriesSota Precision Optics, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK040691 Intra Oral Camera System & Accessories, Model Win-100DWin-Us Technology Co., Ltd. · 2004
Most influential descendants
Showing 3 of 3 · See all- K032341Intra Oral Camera System and Accessories, Model Claris I310Sota Precision Optics, Inc. · 2003 · cites it directly1descendant
- K061175Claris I310D Intraoral Camera System & AccessoriesSota Precision Optics, Inc. · 2006 · 2 generations on0descendants
- K040691Intra Oral Camera System & Accessories, Model Win-100DWin-Us Technology Co., Ltd. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981663 | Digital Doc | Digital Doc, LLC | 1998 | — |
| +1 | K032341 | Intra Oral Camera System and Accessories, Model Claris I310 | Sota Precision Optics, Inc. | 2003 | — |
| +2 | K061175 | Claris I310D Intraoral Camera System & Accessories | Sota Precision Optics, Inc. | 2006 | — |
| +1 | K040691 | Intra Oral Camera System & Accessories, Model Win-100D | Win-Us Technology Co., Ltd. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K032341 (Sota Precision Optics, Inc., 2003) has gone furthest, with 1 descendant of its own.
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 intraoral camera system, Digital Doc, of Digital Doc, Inc. is used to provide a view of the mouth in order to assist the dentist in describing dental procedureé and to show a patient before and after views of his mouth showing the patient results of the dental procedures which the dentist has performed on him.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981663 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981663: Digital Doc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981663
Report an extraction error
Are you the manufacturer?
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