510(k) · Cleared
ClearedDental Barrier and Sleeves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yongqing Huaguan Dental Instruments Factory · PEM Dental Barriers And Sleeves
Cleared on May 9, 2024 as substantially equivalent to K190484 (Bh Medical Products Co., Ltd., 2019) after a 148-day review. Its family tree reaches back 3 generations to 2014. 2 later devices descend from it.
- Decided
- May 9, 2024
- Review
- 148 days
- Class
- Class II
- Product code
- PEM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K132953 (2014). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK132953 TidisheildTidi Products,Llc · 2014
- 2 generations backK151123 Pac-Dent Barrier Sleeve, Cover-It (TM) Barrier FilmPac-Dent International, Inc. · 2016
- 1 generation backK190484 BH Medical Dental Barrier Sleeves and Barrier FilmBh Medical Products Co., Ltd. · 2019
- This deviceK233918 Dental Barrier and SleevesYongqing Huaguan Dental Instruments Factory · 2024
- Descendant · cites it directly · 1 of its ownK250606 Dental Barrier and SleevesYueying Medical Instruments (Langfang) Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK262073 Hygienic Protective Bite Cover (2207-010-50)Dürr Dental SE · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K132953 | Tidisheild | Tidi Products,Llc | 2014 | — |
| −2 | K151123 | Pac-Dent Barrier Sleeve, Cover-It (TM) Barrier Film | Pac-Dent International, Inc. | 2016 | — |
| −1 | K190484 | BH Medical Dental Barrier Sleeves and Barrier Film | Bh Medical Products Co., Ltd. | 2019 | — |
| 0 (this device) | K233918 | Dental Barrier and Sleeves | Yongqing Huaguan Dental Instruments Factory | 2024 | — |
| +1 | K250606 | Dental Barrier and Sleeves | Yueying Medical Instruments (Langfang) Co., Ltd. | 2025 | — |
| +2 | K262073 | Hygienic Protective Bite Cover (2207-010-50) | Dürr Dental SE | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K190484 | BH Medical Dental Barrier Sleeves and Barrier FilmSummary page 5…gical Drape And Drape Accessories Classification: Class II Product code: PEM Regulation Number: 21 CFR 878.4370 C. Predicate device: Predicate Device: K190484 Product name: BH Medical Dental Barrier Sleeves and Barrier Film Manufacturer: BH Medical Products Co., Ltd. D. Intend… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250606 | Dental Barrier and Sleeves | 2025 | 1 |
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 10 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K250606 (Yueying Medical Instruments (Langfang) Co., Ltd., 2025) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K190484.
How does its category compare?
All PEM devicesPEM Dental Barriers And Sleeves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Dental Barrier and Sleeves are 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.
See the attached table for the model numbers and descriptions in 510(k) Summary.
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/K233918 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233918: Dental Barrier and Sleeves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233918
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