510(k) · Cleared
Recalled · Class II · 2016Perioview Model DV-1 Fiberscope and Window Sheath.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentalview, Inc. · EIA Unit, Operative Dental
Cleared on Sep 15, 1998 after a 61-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 32 later devices descend from it. It has been recalled once.
- Decided
- Sep 15, 1998
- Review
- 61 days
- Class
- Class I
- Product code
- EIA
- Recalls
- 1
- Predicates
- 0
32 later devices descend from it, 1 citing it directly.
- This deviceK982480 Perioview Model DV-1 Fiberscope and Window Sheath.Dentalview, Inc. · 1998
- Descendant · cites it directly · 31 of its ownK023367 Detectar, Model N123-MINeks Technologies · 2003
- Descendant · 2 generations on · 28 of its ownK042394 Diagnodent Perio Tip (Accessory)Kavo America Corporation · 2005
- Descendant · 3 generations on · 27 of its ownK060080 Diagnodent 2190 with Periodontal ProbeKavo Dental Corporation · 2006
- Descendant · 3 generations on · 26 of its ownK073074 Key Laser Iii 1243 US with DetectKavo America · 2008
- Descendant · 4 generations on · 25 of its ownK101658 Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc. · 2010 · Recalled
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K023367Detectar, Model N123-MINeks Technologies · 2003 · cites it directly31descendants
- K042394Diagnodent Perio Tip (Accessory)Kavo America Corporation · 2005 · 2 generations on28descendants
- K060080Diagnodent 2190 with Periodontal ProbeKavo Dental Corporation · 2006 · 3 generations on27descendants
- K073074Key Laser Iii 1243 US with DetectKavo America · 2008 · 3 generations on26descendants
- K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc. · 2010 · 4 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982480 | Perioview Model DV-1 Fiberscope and Window Sheath. | Dentalview, Inc. | 1998 | — |
| +1 | K023367 | Detectar, Model N123-MI | Neks Technologies | 2003 | — |
| +2 | K042394 | Diagnodent Perio Tip (Accessory) | Kavo America Corporation | 2005 | — |
| +3 | K060080 | Diagnodent 2190 with Periodontal Probe | Kavo Dental Corporation | 2006 | — |
| +3 | K073074 | Key Laser Iii 1243 US with Detect | Kavo America | 2008 | — |
| +4 | K101658 | Waterlase MD Turbo Plus Model 7200XXX | Biolase Technology, Inc. | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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? (32)
See all 321 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023367 | Detectar, Model N123-MI | 2003 | 31 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 24, 2016 | Class II | Z-2530-2016 | Under Investigation by firm | The Perioscopy Sheaths are currently provided with a label that indicates the Sheath has a 3 year shelf-life/expiry date. Danville Materials has become aware that validation data are not available to support the 3-year… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K023367 (Neks Technologies, 2003) has gone furthest, with 31 descendants 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 PerioView Model DV-1 Fiberscope and Window Sheath is intended to be used with the PerioView family of dental instruments in direct visualization and therapy of periodontal disease and other situations that would require visualization of structures beneath the intact gum line within the oral cavity.
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/K982480 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982480: Perioview Model DV-1 Fiberscope and Window Sheath..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982480
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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