510(k) · Cleared
ClearedAcucam Intraoral Camera Sheaths, Models 023545, 601111, 300407, 601285
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · KKX Drape, Surgical, Antimicrobial
Cleared on Feb 4, 2000 as substantially equivalent to K983406 (Banta Healthcare Group, Ltd., 1998) after a 52-day review. Its family tree reaches back 2 generations to 1987.
- Decided
- Feb 4, 2000
- Review
- 52 days
- Class
- Class II
- Product code
- KKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K871465 (1987). No later device cites it as a predicate yet.
- Root · 2 generations backK871465 Thermometer SheathsAbco Dealers, Inc. · 1987
- 1 generation backK983406 Sanitherm Oral Disposable Thermometer Sheaths for Mercury…Banta Healthcare Group, Ltd. · 1998
- This deviceK994211 Acucam Intraoral Camera Sheaths, Models 023545, 601111, 300407, 601285Dentsply Intl. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871465 | Thermometer Sheaths | Abco Dealers, Inc. | 1987 | — |
| −1 | K983406 | Sanitherm Oral Disposable Thermometer Sheaths for Mercury Thermometer… | Banta Healthcare Group, Ltd. | 1998 | — |
| 0 (this device) | K994211 | Acucam Intraoral Camera Sheaths, Models 023545, 601111, 300407, 601285 | Dentsply Intl. | 2000 | — |
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 KKX? 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 KKX device
- #1 K222578 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise…score 5.7 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K983406 | Sanitherm Oral Disposable Thermometer Sheaths for Mercury Thermometer, Senitherm Oral…Summary page 3…era Sheath Common Name: AcuCam Sheath Classification Name: Dental Operative Device, EIA, 872.6640 Predicate Device: Sanitherm Oral Disposable Thermometer Sheath, 510(k) K983406 Product Description: The AcuCam Intraoral Camera Sheath is a single-use device intended for use with intraoral camera systems. T… | 1998 |
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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 11.4 years on median.
- None of the 2 ancestors has a recall.
- 6 other devices also cite its predicate K983406.
How does its category compare?
All KKX devicesKKX Drape, Surgical, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KKX
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · KKX
182in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KKX
2in 2024
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · KKX
24in 2025
MAUDE reports naming product code KKX, 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 | 4 | 181 | 1 | 24 |
| 2008 | 5 | 164 | 0 | 24 |
| 2009 | 5 | 114 | 0 | 27 |
| 2010 | 8 | 107 | 1 | 25 |
| 2011 | 4 | 147 | 1 | 57 |
| 2012 | 2 | — | 1 | 40 |
| 2013 | 3 | 227 | 7 | 63 |
| 2014 | 6 | 182 | 7 (7) | 28 |
| 2015 | 2 | — | 0 | 33 |
| 2016 | 0 | — | 4 | 56 |
| 2017 | 1 | — | 0 | 30 |
| 2018 | 0 | — | 0 | 32 |
| 2019 | 0 | — | 0 | 41 |
| 2020 | 1 | — | 0 | 16 |
| 2021 | 1 | — | 0 | 41 |
| 2022 | 0 | — | 0 | 19 |
| 2023 | 2 | — | 0 | 32 |
| 2024 | 0 | — | 2 | 19 |
| 2025 | 0 | — | 0 | 24 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The AcuCam® Intraoral Camera Sheath is a single-use device intended for use with the various intraoral camera systems to prevent contamination of the camera handpiece 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/K994211 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994211: Acucam Intraoral Camera Sheaths, Models 023545, 601111, 300407, 601285.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994211
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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