510(k) · Cleared
ClearedTidisheild
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tidi Products,Llc · PEM Dental Barriers And Sleeves
Cleared on Feb 18, 2014 after a 151-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 14 later devices descend from it.
- Decided
- Feb 18, 2014
- Review
- 151 days
- Class
- Class II
- Product code
- PEM
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 3 citing it directly.
- This deviceK132953 TidisheildTidi Products,Llc · 2014
- Descendant · cites it directly · 9 of its ownK151123 Pac-Dent Barrier Sleeve, Cover-It (TM) Barrier FilmPac-Dent International, Inc. · 2016
- Descendant · 2 generations on · 4 of its ownK190484 BH Medical Dental Barrier Sleeves and Barrier FilmBh Medical Products Co., Ltd. · 2019
- Descendant · cites it directly · 3 of its ownK160232 Disposable Barrier Sleeves and CoversDentsply International, Inc. · 2016
- Descendant · 3 generations on · 2 of its ownK233918 Dental Barrier and SleevesYongqing Huaguan Dental Instruments Factory · 2024
- Descendant · 3 generations on · 1 of its ownK250606 Dental Barrier and SleevesYueying Medical Instruments (Langfang) Co., Ltd. · 2025
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K151123Pac-Dent Barrier Sleeve, Cover-It (TM) Barrier FilmPac-Dent International, Inc. · 2016 · cites it directly9descendants
- K190484BH Medical Dental Barrier Sleeves and Barrier FilmBh Medical Products Co., Ltd. · 2019 · 2 generations on4descendants
- K160232Disposable Barrier Sleeves and CoversDentsply International, Inc. · 2016 · cites it directly3descendants
- K233918Dental Barrier and SleevesYongqing Huaguan Dental Instruments Factory · 2024 · 3 generations on2descendants
- K250606Dental Barrier and SleevesYueying Medical Instruments (Langfang) Co., Ltd. · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K132953 | Tidisheild | Tidi Products,Llc | 2014 | — |
| +1 | K151123 | Pac-Dent Barrier Sleeve, Cover-It (TM) Barrier Film | Pac-Dent International, Inc. | 2016 | — |
| +2 | K190484 | BH Medical Dental Barrier Sleeves and Barrier Film | Bh Medical Products Co., Ltd. | 2019 | — |
| +1 | K160232 | Disposable Barrier Sleeves and Covers | Dentsply International, Inc. | 2016 | — |
| +3 | K233918 | Dental Barrier and Sleeves | Yongqing Huaguan Dental Instruments Factory | 2024 | — |
| +3 | K250606 | Dental Barrier and Sleeves | Yueying Medical Instruments (Langfang) Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (14)
See all 143 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?
- Of its descendants, K151123 (Pac-Dent International, Inc., 2016) has gone furthest, with 9 descendants of its own.
How does its category compare?
All PEM devicesPEM Dental Barriers And Sleeves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 TIDiShield Curing Light Sleeves are indicated for use as a barrier that is used as an accessory to dental instrument. These sleeves are non-sterile and are intended for single patient use only.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K132953 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132953: Tidisheild.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132953
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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