510(k) · Cleared
ClearedDenoptix Barrier Envelope (Size 0-4)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Apr 14, 1998 as substantially equivalent to K884827 (Eastman Kodak Company, 1989) after a 61-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Apr 14, 1998
- Review
- 61 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K884827 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK884827 Kodak Dental Barrier PacEastman Kodak Company · 1989
- This deviceK980543 Denoptix Barrier Envelope (Size 0-4)Dentsply Intl. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K884827 | Kodak Dental Barrier Pac | Eastman Kodak Company | 1989 | — |
| 0 (this device) | K980543 | Denoptix Barrier Envelope (Size 0-4) | Dentsply Intl. | 1998 | — |
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 EHD? 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 EHD device
- #1 K260795 Hand-held Dental X-ray System (HyperLight-M)score 14.1 · 8 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 |
|---|---|---|---|
| * | K884827 | Kodak Dental Barrier PacSummary page 1…-4970 o FeBRuARY 9, (198 DenOptix Barrier Envelope Dental Barrier Envelope Electrostatic X-ray Imaging System, IXK, 892.1630 Kodak ClinAsept Barrier Envelope, 510(k) K884827 The DenOptix Barrier Envelope is a single-use pouch available in sizes corresponding to standard intra-oral imaging plate dimens… | 1989 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All EHD devicesEHD Unit, X-Ray, Extraoral With Timer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EHD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EHD
58in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EHD
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EHD
6in 2024
MAUDE reports naming product code EHD, 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 | 1 | — | 0 | 5 |
| 2008 | 5 | 49 | 0 | 6 |
| 2009 | 4 | 92 | 0 | 38 |
| 2010 | 4 | 268 | 3 | 47 |
| 2011 | 3 | 102 | 3 | 26 |
| 2012 | 2 | — | 0 | 22 |
| 2013 | 4 | 216 | 0 | 21 |
| 2014 | 3 | 107 | 1 | 20 |
| 2015 | 1 | — | 0 | 110 |
| 2016 | 2 | — | 1 | 63 |
| 2017 | 4 | 28 | 1 | 66 |
| 2018 | 5 | 30 | 0 | 21 |
| 2019 | 4 | 173 | 0 | 21 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 8 | 58 | 0 | 4 |
| 2023 | 8 | 147 | 0 | 2 |
| 2024 | 7 | 58 | 0 | 6 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 6 | 128 | 0 | — |
What is it indicated for?
The DenOptix Barrier Envelope is a single-use device intended for use with the DenOptix Digital Imaging System (K955643) to prevent contamination of the phosphor imaging plate with saliva and other bodily fluids.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980543: Denoptix Barrier Envelope (Size 0-4).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980543
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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