510(k) · Cleared
ClearedBH Medical Dental Barrier Sleeves and Barrier Film
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bh Medical Products Co., Ltd. · PEM Dental Barriers And Sleeves
Cleared on Sep 10, 2019 as substantially equivalent to K151123 (Pac-Dent International, Inc., 2016) after a 195-day review. Its family tree reaches back 2 generations to 2014. 4 later devices descend from it.
- Decided
- Sep 10, 2019
- Review
- 195 days
- Class
- Class II
- Product code
- PEM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K132953 (2014). 4 later devices descend from it, 3 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 deviceK190484 BH Medical Dental Barrier Sleeves and Barrier FilmBh Medical Products Co., Ltd. · 2019
- Descendant · cites it directly · 2 of its ownK233918 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
- Descendant · cites it directly · 0 of its ownK250735 Dental Barrier and SleevesFomed Industries, Inc. · 2025
Most influential descendants
Showing 4 of 4 · See all- K233918Dental Barrier and SleevesYongqing Huaguan Dental Instruments Factory · 2024 · cites it directly2descendants
- K250606Dental Barrier and SleevesYueying Medical Instruments (Langfang) Co., Ltd. · 2025 · cites it directly1descendant
- K262073Hygienic Protective Bite Cover (2207-010-50)Dürr Dental SE · 2026 · 2 generations on0descendants
- K250735Dental Barrier and SleevesFomed Industries, Inc. · 2025 · 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) | K190484 | BH Medical Dental Barrier Sleeves and Barrier Film | Bh Medical Products Co., Ltd. | 2019 | — |
| +1 | 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 | — |
| +1 | K250735 | Dental Barrier and Sleeves | Fomed Industries, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K151123 | Pac-Dent Barrier Sleeve, Cover-It (TM) Barrier FilmSummary page 5…4370 Product Code: PEM Predicate Device to BH Medical Dental Barrier Sleeves and Barrier Film: Trade Name: Pac-Dent Barrier Sleeve, Cover-It Barrier Film 510(k) Number: K151123 Manufactured by: Pac-Dent International, Inc. Device Description: BH Medical Dental Barrier Sleeves and Barrier Film consist of… | 2016 |
What descends from it? (4)
3 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?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K233918 (Yongqing Huaguan Dental Instruments Factory, 2024) has gone furthest, with 2 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. 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?
BH Medical Dental Barrier Sleeves and Barrier Film 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. Item # Model Designed for #992514 B tray sleeves Dental instrument tray, 10 1/2"x14"(360x270mm) #992515 E tray sleeves Dental instrument tray, 11 1/2"x16"(410x290mm) #992516 A tray sleeves Dental instrument tray, 7 1/2"x10 1/2"(270x190mm) #992446…
Read the full statement (545 words)
BH Medical Dental Barrier Sleeves and Barrier Film 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.
Item # Model Designed for
#992514 B tray sleeves Dental instrument tray, 10 1/2"x14"(360x270mm)
#992515 E tray sleeves Dental instrument tray, 11 1/2"x16"(410x290mm)
#992516 A tray sleeves Dental instrument tray, 7 1/2"x10 1/2"(270x190mm)
#992446 Headrest Cover Dental chair headrest, 11"x9 1/2"(250x280mm)
#992447 Headrest Cover Dental chair headrest, 14"x9 1/2"(250x360mm)
#992513 X-ray head sleeves X-ray head, universal, 15"x26"(660x380mm)
#992481 Full chair sleeves Dental chair, universal, 29"x80"(2020x730mm)
#992479 Half chair sleeves Half dental chair, universal, 27 1/2"x24"(680x600mm)
#992486 Syringe/HVE sleeve without tape Air/water syringe HVE universal, 2 1/2"x10"(250x60x22mm)
#991372 Digital x-ray sensor sleeve Digital x-ray sensor, universal, large, 1 5/8"x8"(210x43mm)
#991371 Digital x-ray sensor sleeve Digital x-ray sensor, universal, large, 1 3/8"x8"(210x36mm)
#992492 handpiece and pen sleeves-High speed Dental high-speed handpiece universal(200x28mm)
#992493 handpiece and pen sleeves-Lower speed Dental low-speed handpiece universal(200x38mm)
#992499 light handle sleeves light handles, universal, T-shape(154x73mm)
#992508 light handle sleeves light handles, universal, Rectanglar(150x105mm)
#992495 light cure sleeves Dental curing light, medium,20mm
#992496 light cure sleeves Dental curing light, large,25mm
#992497 light cure sleeves, curved tip Dental curing light, medium,(340x53x16mm)
#992498 light cure sleeves, curved tip Dental curing light, large,(340x84x16mm)
#992582 light cure sleeves, pen style Dental curing light, pen type,tip:40x27mm,total:250x50mm
#992583 light cure sleeves, pen style Dental curing light, pen type,,tip:55x26mm,total:250x52mm
#992584 light cure sleeves, pen style Dental curing light, pen type,tip:40x30mm,total:250x55mm
#991361 Barrier envelopes size 0 Digital x-ray sensor(Kodak 6100 size 0）,inner :36x23mm
#991362 Barrier envelopes size 1 Digital x-ray sensor(Kodak 6100 size 1）,inner :42x26mm
#991363 Barrier envelopes size 2 Digital x-ray sensor(Kodak 6100 size 2）,inner :45x33mm
#991364 Barrier envelopes size 3 Digital x-ray sensor(Kodak 6100 size 3）,inner :56x30mm
#991365 Barrier envelopes size 4 Digital x-ray sensor(Kodak 6100 size 4）,inner :80x60mm
#992489 Tubing sleeves roll（2“） Dental unit tubing, 2”,(50mm)
#992490 Tubing sleeves roll（4“） Dental unit tubing, 4”,(100mm)
#992483 Barrier film white Surface area that might be touched during procedure 4"x6",white,10cmx15cmx180m
#992482 Barrier film blue Surface area that might be touched during procedure 4"x6",blue,10cmx15cmx180m
#992585 Intraoral Camera Sleeves Digital intraoral camera sleeves, DMD Telicam, 228x43x13.5mm
#992586 Intraoral Camera Sleeves Digital intraoral camera sleeves, Siemens Ceracam/minicam Ultra, 228x43x24mm
#992587 Intraoral Camera Sleeves Digital intraoral camera sleeves, Dentsply Acucap Concept, 228x43x16.6mm
#992588 Intraoral Camera Sleeves Digital intraoral camera sleeves, Camsight OptumII, 228x25x17mm
#992589 Intraoral Camera Sleeves Digital intraoral camera sleeves, RF System SS21, 228x57x22mm
#992590 Intraoral Camera Sleeves Digital intraoral camera sleeves, Suni Sunic-am,228x48x31mm
#992591 Intraoral Camera Sleeves Digital intraoral camera sleeves, Digital Doc Iris,228x41x19mm
#992592 Intraoral Camera Sleeves Digital intraoral camera sleeves, Vision Tools Spectra Vu, 228x57x12mm
#992593 Intraoral Camera Sleeves Digital intraoral camera sleeves, Imagin Hot Rod, 228x50x17.5mm
#992594 Intraoral Camera Sleeves Digital intraoral camera sleeves, Carestream STV Pro I&II Kodak 1000, 228x35x18mm
#992595 Intraoral Camera Sleeves Digital intraoral camera sleeves, Video Dental Concepts Miniscope & Microscope TD-2000,228x53x29mm
#992596 Intraoral Camera Sleeves Digital intraoral camera sleeves, DMD Telicam Digital Doc Aurara, 228x35x22mm
#991367 Barrier envelopes size 0 Digital x-ray sensor (size 0),inner :25x37mm
#991368 Barrier envelopes size 1 Digital x-ray sensor (size 1),inner :26.5x43mm
#991369 Barrier envelopes size 2 Digital x-ray sensor (size 2),inner :44x33mm
#991374 Sensor sleeves Dental instrument tray, 100x43mm
#991373 Sensor sleeves Dental instrument tray, 250x63mm
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190484 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190484: BH Medical Dental Barrier Sleeves and Barrier Film.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190484
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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