510(k) · Cleared
ClearedUltracam
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dental Vision Direct, Inc. · EIA Unit, Operative Dental
Cleared on Mar 31, 1994 after a 246-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Mar 31, 1994
- Review
- 246 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK933671 UltracamDental Vision Direct, Inc. · 1994
- Descendant · cites it directly · 1 of its ownK991011 OrascopeFiberdent Corp. · 1999
- Descendant · cites it directly · 1 of its ownK981937 Welch Allyn Reveal Intraoral Camera SystemWelch Allyn, Inc. · 1998
- Descendant · 2 generations on · 0 of its ownK093785 Modular EndoscopeSialo Technology, Ltd. · 2010
- Descendant · 2 generations on · 0 of its ownK984556 Scican ClassicScholly Fiberoptic GmbH · 1999
Most influential descendants
Showing 4 of 4 · See all- K991011OrascopeFiberdent Corp. · 1999 · cites it directly1descendant
- K981937Welch Allyn Reveal Intraoral Camera SystemWelch Allyn, Inc. · 1998 · cites it directly1descendant
- K093785Modular EndoscopeSialo Technology, Ltd. · 2010 · 2 generations on0descendants
- K984556Scican ClassicScholly Fiberoptic GmbH · 1999 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K933671 | Ultracam | Dental Vision Direct, Inc. | 1994 | — |
| +1 | K991011 | Orascope | Fiberdent Corp. | 1999 | — |
| +1 | K981937 | Welch Allyn Reveal Intraoral Camera System | Welch Allyn, Inc. | 1998 | — |
| +2 | K093785 | Modular Endoscope | Sialo Technology, Ltd. | 2010 | — |
| +2 | K984556 | Scican Classic | Scholly Fiberoptic GmbH | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
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, 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 | — |
https://510kreport.com/device/K933671 · printed Nov 4, 2026
Cite this page
510(k) Report. “K933671: Ultracam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K933671
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026