# K190484: BH Medical Dental Barrier Sleeves and Barrier Film

- Pathway: 510(k) (Traditional)
- Applicant: Bh Medical Products Co., Ltd.
- Decided: Sep 10, 2019 after 195 days
- Product code: PEM (Dental Barriers And Sleeves)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K132953 (2014). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151123: Pac-Dent Barrier Sleeve, Cover-It (TM) Barrier Film, Pac-Dent International, Inc. (2016) Summary page 5.

## Most influential descendants
- K233918: Dental Barrier and Sleeves (2024), 2 descendants of its own
- K250606: Dental Barrier and Sleeves (2025), 1 descendant of its own
- K262073: Hygienic Protective Bite Cover (2207-010-50) (2026), 0 descendants of its own
- K250735: Dental Barrier and Sleeves (2025), 0 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K190484
Methodology: https://510kreport.com/methodology