# K151123: Pac-Dent Barrier Sleeve, Cover-It (TM) Barrier Film

- Pathway: 510(k) (Traditional)
- Applicant: Pac-Dent International, Inc.
- Decided: Mar 3, 2016 after 310 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: 1 generation back to K132953 (2014). 1 ancestor in all.
9 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132953: Tidisheild, Tidi Products,Llc (2014) Summary page 5.

## Most influential descendants
- K190484: BH Medical Dental Barrier Sleeves and Barrier Film (2019), 4 descendants of its own
- K233918: Dental Barrier and Sleeves (2024), 2 descendants of its own
- K250606: Dental Barrier and Sleeves (2025), 1 descendant of its own
- K163447: Premium Plus Disposable Barrier Sleeve (2017), 1 descendant of its own
- K262073: Hygienic Protective Bite Cover (2207-010-50) (2026), 0 descendants of its own

## Indications for use
Pac-Dent Barrier Sleeve and Cover-It Barrier Film are intended to be used as a barrier to cover dental instruments. This device is non-sterile and is intended for single patient use only. Item# Model Designed for 101 B tray sleeves Dental instrument tray (size B) 101A A tray sleeves Dental instrument tray (size A) 102 Headrest cover Dental chair headrest, 11"X9 1/2" 103 Headrest cover Dental chair headrest, jumbo, 14"X9 1/2" 104 F tray sleeves Dental instrument tray (size F) 109 X-Ray sleeves X-Ray head, universal, 15"X26" 110 Universal X-Ray sleeves X-Ray head, universal, extra-long, 23"X31" 111 Full chair sleeves Dental chair, universal, 29"X80" 111SG S&G full chair sleeves Dental chair, Slip and Grip, 48"X56" 112 Half chair sleeves Half dental chair, universal, 27 1/2"X24" 100 Syringe sleeve w. opening, clear Air/water syringe HVE, universal 100B Syringe sleeve w. opening, blue Air/water syringe HVE, universal 100L Digital sensor sleeve Digital X-Ray sensor, universal, large, 1 5/8"X8" 100S Digital sensor sleeve Digital X-Ray sensor, universal, small, 1 3/8"X8" 103HP High-speed handpiece sleeves Dental high-speed handpiece, universal 104HP Low-speed handpiece sleeves Dental low-speed handpiece, universal 106 “T” handle sleeves T-style light handles, universal 190LED Sleeves for L.E. Demetron Dental curing light (L.E. Demetron) D250 LED Curing light sleeves for Demi Dental curing light (Demi) S121 Keyboard sleeves Computer keyboard, universal, 22"X14" S122 Keyboard sleeves Computer keyboard, large, 19"X26" S123 LCD & Keyboard sleeves Computer screen and keyboard, universal S124 Laptop sleeves Laptop, universal LCH500 Low-speed contra-angle handpiece sleeves w/paper backing Dental low-speed contra-angle handpiece, universal LLH500 Low-speed long handpiece sleeves w/paper backing Dental low-speed long handpiece, universal CM500 Optical PC mouse barriers Computer mouse, universal AWP400 Syringe sleeve W/paper backing Air/water syringe, universal DX-405 X-ray sensor sheaths, Gender,XDR® Size 1 Digital X-Ray sensor (Gender,XDR® Size 1) DX-406 X-ray sensor sheaths, Gender,XDR® Size 2 Digital X-Ray sensor (Gender,XDR® Size 2) DX-819 X-ray sensor sheaths, Suni/Lightyear Digital X-Ray sensor (Suni/Lightyear) DX-824 X-ray sensor sheaths, Schick/Dr.Suni Plus Digital X-Ray sensor (Schick/Dr.Suni Plus) DX-825 X-ray sensor sheaths, Schick/Dr.Suni Plus Digital X-Ray sensor (Schick/Dr.Suni Plus) DX-890 X-ray sensor sheaths, Sirona Size 2 Digital X-Ray sensor (Sirona Size 2) DX-904 X-ray sensor sheaths, Sirona Size 1 Digital X-Ray sensor (Sirona Size 1) DX-977 X-ray sensor sheaths, Kodak 6100 Size 0 Digital X-Ray sensor (Kodak 6100 Size 0) DX-978 X-ray sensor sheaths, Kodak 6100 Size 1 Digital X-Ray sensor (Kodak 6100 Size 1) DX-979 X-ray sensor sheaths, Kodak 6100 Size 2 Digital X-Ray sensor (Kodak 6100 Size 2) DX-999 X-ray sensor sheaths, Dexis Digital X-Ray sensor (Dexis) PIC250 Complete iCure curing light sleeves Dental curing light (iCure) CS250 Complete curing light sleeves Dental curing light, universal P3720 Tube sleeves(2”) Dental unit tubing (2”) P3740 Tube sleeves(4”) Dental unit tubing (4”) P4550 Curing Light Handle Sleeves Curing light handle, universal C101 Cover It Barrier film, clear Surface area that might be touched during procedure, 4"X6" C101B Cover It Barrier film, blue Surface area that might be touched during procedure, 4"X6"

Source page: https://510kreport.com/device/K151123
Methodology: https://510kreport.com/methodology