510(k) · Cleared
ClearedDisposable Barrier Sleeves and Covers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply International, Inc. · PEM Dental Barriers And Sleeves
Cleared on Jun 7, 2016 as substantially equivalent to K132953 (Tidi Products,Llc, 2014) after a 127-day review. Its family tree reaches back 1 generation to 2014. 3 later devices descend from it.
- Decided
- Jun 7, 2016
- Review
- 127 days
- Class
- Class II
- Product code
- PEM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K132953 (2014). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK132953 TidisheildTidi Products,Llc · 2014
- This deviceK160232 Disposable Barrier Sleeves and CoversDentsply International, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK191448 Barrier SleevesIvoclar Vivadent, AG · 2019
- Descendant · cites it directly · 0 of its ownK261956 Dental Barriers and Sleeves (AB0006)ANI Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK211026 Minitube Dentasleeve Protective Barrier SleevesMinitube AB · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K132953 | Tidisheild | Tidi Products,Llc | 2014 | — |
| 0 (this device) | K160232 | Disposable Barrier Sleeves and Covers | Dentsply International, Inc. | 2016 | — |
| +1 | K191448 | Barrier Sleeves | Ivoclar Vivadent, AG | 2019 | — |
| +1 | K261956 | Dental Barriers and Sleeves (AB0006) | ANI Co., Ltd. | 2026 | — |
| +2 | K211026 | Minitube Dentasleeve Protective Barrier Sleeves | Minitube AB | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K132953 | TidisheildSummary page 7…PEM 3. Predicate Device: Predicate Device Name 510(k) Company Name TIDIShield™ Curing K132953 TIDI Products, LLC Light Sleeve 4. Description of Device: The proposed devices, Dis… | 2014 |
What descends from it? (3)
2 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?
How does its category compare?
All PEM devicesPEM Dental Barriers And Sleeves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Disposable Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.
See the attached table for the product names, trade names and model numbers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160232 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160232: Disposable Barrier Sleeves and Covers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160232
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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