510(k) · Cleared
ClearedPremium Plus Disposable Barrier Sleeve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Premium Plus International Limited · PEM Dental Barriers And Sleeves
Cleared on Jun 20, 2017 as substantially equivalent to K151123 (Pac-Dent International, Inc., 2016) after a 194-day review. Its family tree reaches back 2 generations to 2014. 1 later device descends from it.
- Decided
- Jun 20, 2017
- Review
- 194 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 backK151123 Pac-Dent Barrier Sleeve, Cover-It (TM) Barrier FilmPac-Dent International, Inc. · 2016
- This deviceK163447 Premium Plus Disposable Barrier SleevePremium Plus International Limited · 2017
- Descendant · cites it directly · 0 of its ownK190949 ScanX Barrier EnvelopesAir Techniques, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K190949ScanX Barrier EnvelopesAir Techniques, Inc. · 2019 · 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 | K151123 | Pac-Dent Barrier Sleeve, Cover-It (TM) Barrier Film | Pac-Dent International, Inc. | 2016 | — |
| 0 (this device) | K163447 | Premium Plus Disposable Barrier Sleeve | Premium Plus International Limited | 2017 | — |
| +1 | K190949 | ScanX Barrier Envelopes | Air Techniques, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K151123 | Pac-Dent Barrier Sleeve, Cover-It (TM) Barrier FilmSummary page 4…s Ⅱ Regulation Number: 21 CFR 878.4370 Product Code: PEM Predicate Device to Premium Plus Disposable Barrier Sleeves: Trade Name: Pac-Dent Barrier Sleeve 510(k) Number: K151123 Manufactured by: Pac-Dent International, Inc. Device Description: Premium Plus Disposable Barrier Sleeves are made of polyethyle… | 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 |
|---|---|---|---|
| K190949 | ScanX Barrier Envelopes | 2019 | 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 3 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K190949 (Air Techniques, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K151123.
How does its category compare?
All PEM devicesPEM Dental Barriers And Sleeves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Premium Plus Disposable Barrier Sleeve is intended to be used 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/K163447 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163447: Premium Plus Disposable Barrier Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163447
Report an extraction error
Are you the manufacturer?
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