510(k) · Cleared
ClearedBarrier Sleeves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar Vivadent, AG · PEM Dental Barriers And Sleeves
Cleared on Oct 8, 2019 as substantially equivalent to K160232 (Dentsply International, Inc., 2016) after a 130-day review. Its family tree reaches back 2 generations to 2014. 1 later device descends from it.
- Decided
- Oct 8, 2019
- Review
- 130 days
- Class
- Class II
- Product code
- PEM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K132953 (2014). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK132953 TidisheildTidi Products,Llc · 2014
- 1 generation backK160232 Disposable Barrier Sleeves and CoversDentsply International, Inc. · 2016
- This deviceK191448 Barrier SleevesIvoclar Vivadent, AG · 2019
- Descendant · cites it directly · 0 of its ownK211026 Minitube Dentasleeve Protective Barrier SleevesMinitube AB · 2021
Most influential descendants
Showing 1 of 1 · See all- K211026Minitube Dentasleeve Protective Barrier SleevesMinitube AB · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K132953 | Tidisheild | Tidi Products,Llc | 2014 | — |
| −1 | K160232 | Disposable Barrier Sleeves and Covers | Dentsply International, Inc. | 2016 | — |
| 0 (this device) | K191448 | Barrier Sleeves | Ivoclar Vivadent, AG | 2019 | — |
| +1 | K211026 | Minitube Dentasleeve Protective Barrier Sleeves | Minitube AB | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K160232 | Disposable Barrier Sleeves and CoversSummary page 4…(878.4370) • Device Class: II • Product Code PEM Predicate Device: Disposable Barrier Sleeves and Covers (K160232) by DENTSPLY International Inc. Device Description: Barrier Sleeves are made of polyethylene film… | 2016 |
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 |
|---|---|---|---|
| K211026 | Minitube Dentasleeve Protective Barrier Sleeves | 2021 | 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?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K211026 (Minitube AB, 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K160232.
How does its category compare?
All PEM devicesPEM Dental Barriers And Sleeves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Barrier Sleeves 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191448: Barrier Sleeves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191448
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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