510(k) · Cleared
ClearedDental Handpiece and Accessory
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Filmtech, Inc. · EFB Handpiece, Air-Powered, Dental
Cleared on Oct 24, 1996 as substantially equivalent to K900093 (Dentsply Intl., 1990) and 1 other predicate after a 41-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.
- Decided
- Oct 24, 1996
- Review
- 41 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K900093 (1990). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −1 | K900093 | Disposa-Shield (TM) Infection Control Barrier | Dentsply Intl. | 1990 | — |
| 0 (this device) | K963664 | Dental Handpiece and Accessory | Filmtech, Inc. | 1996 | — |
| +1 | K031851 | Dentiseptic HPC | Bethel, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
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 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? (2)
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 |
|---|---|---|---|
| * | K900093 | Disposa-Shield (TM) Infection Control BarrierSummary page 1…sory FDA Classification: Class II per 21 CFR 872.4200 3. Predicate Devices: Filmtech. Inc. claims substantial equivalence for their Brixton Infection Control Barrier to K900093 Dentsply International Inc.’s Disposa-Shield Infection Control Barrier and K952234 Cottrell, Ltd.’s Barrier All Film. 4. Intende… | 1990 |
| * | K952234 | Barrier All FilmSummary page 1…ch. Inc. claims substantial equivalence for their Brixton Infection Control Barrier to K900093 Dentsply International Inc.’s Disposa-Shield Infection Control Barrier and K952234 Cottrell, Ltd.’s Barrier All Film. 4. Intended Use: Brixton Infection Control Barrier is intended as a single use, transparent p… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031851 | Dentiseptic HPC | 2003 | 0 |
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?
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 | — |
What is it indicated for?
Brixton Infection Control Barrier is intended as a single use, transparent plastic, disposable, nonsterile barrier that will help reduce gross contamination and provide equipment surface protection for devices used within the dental/ clinical treatment setting.
Brixton Infection Control Barriers are available in an assortment of sizes and shapes, designed to accommodate the following types of equipment:
* Light Handles
* Chairs
* Headrests
* Air and Water Syringe sleeves (ties included)
* Stools
* X-Ray Heads
* Trays
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/K963664 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963664: Dental Handpiece and Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963664
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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