510(k) · Cleared
ClearedDisposa-Shield (TM) Infection Control Barrier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · EFB Handpiece, Air-Powered, Dental
Cleared on Apr 6, 1990 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Apr 6, 1990
- Review
- 88 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK900093 Disposa-Shield (TM) Infection Control BarrierDentsply Intl. · 1990
- Descendant · cites it directly · 2 of its ownK962288 Cover-All, Drape-IT-All, Chair Sleve, X-Ray Sleeve, Headrest CoverPinnacle Products, Inc. · 1997 · Recalled
- Descendant · 2 generations on · 1 of its ownK014239 Medsurg Equipment CoversInternational Medsurg Connection · 2002
- Descendant · cites it directly · 1 of its ownK963664 Dental Handpiece and AccessoryFilmtech, Inc. · 1996
- Descendant · 2 generations on · 0 of its ownK041501 Guangzhou Fortunique Drapes, Bags and CoversGuangzhou Fortunique, Ltd. · 2004 · Recalled
- Descendant · cites it directly · 0 of its ownK031851 Dentiseptic HPCBethel, Inc. · 2003
Most influential descendants
Showing 5 of 5 · See all- K962288Cover-All, Drape-IT-All, Chair Sleve, X-Ray Sleeve, Headrest CoverPinnacle Products, Inc. · 1997 · cites it directly2descendants
- K014239Medsurg Equipment CoversInternational Medsurg Connection · 2002 · 2 generations on1descendant
- K963664Dental Handpiece and AccessoryFilmtech, Inc. · 1996 · cites it directly1descendant
- K041501Guangzhou Fortunique Drapes, Bags and CoversGuangzhou Fortunique, Ltd. · 2004 · 2 generations on0descendants
- K031851Dentiseptic HPCBethel, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K900093 | Disposa-Shield (TM) Infection Control Barrier | Dentsply Intl. | 1990 | — |
| +1 | K962288 | Cover-All, Drape-IT-All, Chair Sleve, X-Ray Sleeve, Headrest Cover | Pinnacle Products, Inc. | 1997 | 3 |
| +2 | K014239 | Medsurg Equipment Covers | International Medsurg Connection | 2002 | — |
| +1 | K963664 | Dental Handpiece and Accessory | Filmtech, Inc. | 1996 | — |
| +2 | K041501 | Guangzhou Fortunique Drapes, Bags and Covers | Guangzhou Fortunique, Ltd. | 2004 | 6 |
| +1 | K031851 | Dentiseptic HPC | Bethel, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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 EFB? 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 EFB device
- #1 K262144 DIAMED Handpiece;DIAMED Airmotor;DIAMED…score 13.3 · 5 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? (5)
3 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, K962288 (Pinnacle Products, Inc., 1997) has gone furthest, with 2 descendants of its own.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EFB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EFB
209in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EFB
No recall names EFB since 2007.
Adverse event reports per year · EFB
83in 2025
MAUDE reports naming product code EFB, 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 | 12 | 61 | 0 | 13 |
| 2008 | 7 | 97 | 0 | 19 |
| 2009 | 11 | 120 | 0 | 40 |
| 2010 | 8 | 116 | 0 | 78 |
| 2011 | 4 | 168 | 0 | 96 |
| 2012 | 8 | 130 | 0 | 97 |
| 2013 | 3 | 207 | 0 | 61 |
| 2014 | 7 | 200 | 0 | 73 |
| 2015 | 7 | 296 | 0 | 87 |
| 2016 | 3 | 205 | 0 | 122 |
| 2017 | 7 | 246 | 0 | 153 |
| 2018 | 3 | 210 | 0 | 81 |
| 2019 | 3 | 348 | 0 | 117 |
| 2020 | 5 | 259 | 0 | 94 |
| 2021 | 2 | — | 0 | 123 |
| 2022 | 5 | 430 | 0 | 157 |
| 2023 | 4 | 158 | 0 | 116 |
| 2024 | 5 | 209 | 0 | 104 |
| 2025 | 1 | — | 0 | 83 |
| 2026 | 4 | 252 | 0 | — |
https://510kreport.com/device/K900093 · printed Nov 6, 2026
Cite this page
510(k) Report. “K900093: Disposa-Shield (TM) Infection Control Barrier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900093
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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