510(k) · Cleared
ClearedTelicam
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dental/Medical Diagnostic Systems, Inc. · EIA Unit, Operative Dental
Cleared on Apr 13, 1998 after a 66-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Apr 13, 1998
- Review
- 66 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980474 | Telicam | Dental/Medical Diagnostic Systems, Inc. | 1998 | — |
| +1 | K991011 | Orascope | Fiberdent Corp. | 1999 | — |
| +2 | K093785 | Modular Endoscope | Sialo Technology, Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2010 | 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? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991011 | Orascope | 1999 | 1 |
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, K991011 (Fiberdent Corp., 1999) 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?
Non diagnostic intraoral camera used by dentists to illuminate and magnify dental surfaces.
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/K980474 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980474: Telicam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980474
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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