510(k) · Cleared
ClearedDental Barriers and Sleeves (AB0006)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ANI Co., Ltd. · PEM Dental Barriers And Sleeves
Cleared on Sep 8, 2026 as substantially equivalent to K132953 (Tidi Products,Llc, 2014) and 1 other predicate after an 89-day review. Its family tree reaches back 2 generations to 2014.
- Decided
- Sep 8, 2026
- Review
- 89 days
- Class
- Class II
- Product code
- PEM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K132953 (2014). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 PEM? 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 PEM device
- #1 K250606 Dental Barrier and Sleevesscore 13.3 · 4 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 |
|---|---|---|---|
| * | K132953 | TidisheildSummary page 6…ice No. 1 Primary Manufacturer TIDI Products, LLC Device Name TIDIShield Curing Light Sleeve 510(k) Number K132953 Regulation Name Dental Barriers and Sleeves Regulation Number 21 CFR 878.4370 Reg… | 2014 |
| * | K160232 | Disposable Barrier Sleeves and CoversSummary page 7…edicate device No. 2 Primary Manufacturer DENTSPLY International Device Name Dental Barriers and Sleeves 510(k) Number K160232 Regulation Name Surgical Drape and Drape Accessories Regulation Number 21 CFR 878.4370 V.… | 2016 |
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 12 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K132953.
How does its category compare?
All PEM devicesPEM Dental Barriers And Sleeves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PEM
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PEM
163in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PEM
No recall names PEM since 2007.
Adverse event reports per year · PEM
No MAUDE report names PEM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 4 | 163 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Dental Barriers and Sleeves are intended to be used as a barrier to cover dental instruments.
This device is non-sterile and is intended for single patient use only.
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/K261956 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261956: Dental Barriers and Sleeves (AB0006).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261956
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026