# K183263: UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope

- Pathway: 510(k) (Traditional)
- Applicant: Unipack Medical Corporation
- Decided: Jun 14, 2019 after 203 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.
No later device cites it as a predicate yet.
0 of 3 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 6.

## Indications for use
UNiPACK Barrier Sleeve and Barrier Film and UNiGlide Barrier Envelope are intended to be used as a barrier to cover dental instruments. This device is non-sterile and intended for single patient use only. Item # Description Designed For UBC-8010E E Tray Sleeve, 11-1/2" x 16" Instrument trays UBC-8011A A Tray Sleeve, 11-5/8" x 14-1/2" Instrument trays UBC-8012B B Tray Sleeve, 10-1/2" x 14" Instrument trays UBC-8013F F Tray Sleeve, 7-1/2" x 10-1/2" Instrument trays UBC-8021 Full Chair Cover, 29" x 80" Chairs/Stools UBC-8022 Full Chair Cover, 48" x 56" Chairs/Stools UBC-8023 Half Chair Cover, 27-1/2" x 24" Chair Headrest UBC-8024 Headrest Cover, 11" x 9-1/2" x 2" Chair Headrest UBC-8025 Headrest Cover, 14" x 9-1/2" x 2" Chair Headrest UBC-8028 Syringe Sleeve with Opening, Clear, 2-1/2"x 10" 3-way syringes, saliva ejectors and HVE valves UBC-8029 Syringe Sleeve with Opening, Blue, 2-1/2"x 10" 3-way syringes, saliva ejectors and HVE valves UBC-8031 T-Handle Cover (T Shape), 4" x 5-3/4" Most T-style dental chair light handles UBC-8032 Universal X-Ray Cover, 23" x 31" X-Ray head, Extra-Long UBC-8033 Universal X-Ray Cover, 15" x 26" X-Ray head, Regular UBC-8034 Curing Light, Pistol (Handle Only) Curing Lights, Pen Type UBC-80341-F Curing Light, Pistol (Full Cover with Vented Design) Curing Lights, Pen Type UBC-80342-S Curing Light, Pen Type (Small), 2" x 12-1/2" Curing Lights, Pen Type UBC-80343-L Curing Light, Pen (Large), 3-1/8" x 12-1/2" Curing Lights, Pen Type UBC-8035 Low Speed Pen Sleeve, 1-1/2" x 9" Curing Lights, Pen Type UBC-8036 High Speed Universal, 1" x 9" Curing Lights, Pen Type UBC-8035 Low Speed Pen Sleeve, 1-1/2" x 9" Curing Lights, Pen Type UBC-8036 High Speed Universal, 1" x 9" Curing Lights, Pen Type UBC-8037 Sensor Sleeve, Size 0 - Small Digital X-Ray sensor, universal, small, 1 3/8"X8" UBC-8038 Sensor Sleeve, Size 2 - Large Digital X-Ray sensor, universal, large, 1 5/8"X8" UBC-80392 Tube Sleeve, 2" x 1200', cut to length Dental unit tubing (2”) UBC-80394 Tube Sleeve, 4" x 1200', cut to length Dental unit tubing (4”) UBC-820824 X-Ray Sensor Sheath (Schick, Size 1) Digital X-Ray sensor (Schick/Dr. Suni Plus) UBC-820825 X-Ray Sensor Sheath (Schick, Size 2) Digital X-Ray sensor (Schick/Dr. Suni Plus) UBC-820861 X-Ray Sensor Sheath (Regam, Size 2) Digital X-Ray sensor (Regam) UBC-820978 X-Ray Sensor Sheath (Carestream/Kodak 6100, Size 1) Digital X Ray sensor (Kodak 6100) UBC-820979 X-Ray Sensor Sheath (Carestream/Kodak 6100, Size 2) Digital X Ray sensor (Kodak 6100) UBC-820999 X-Ray Sensor Sheath (Dexis/Universal) Digital X Ray sensor (Dexis) UBC-820831 Intraoral Camera Covers Pro-Den Systems/Dent-X, Pro-scope 1000 & Oral Scan, Easy Doc UBC-820855 Intraoral Camera Covers Siemens, Ceracam/Minicam Ultra UBC-820963 Intraoral Camera Covers Video Dental concepts, Quickcam Smile UBC-821013 Intraoral Camera Covers Digital Doc, Iris UBE-8160 UNiGLIDE PSP Barrier Envelope Size 0 Phosphor Plate Covers UBE-8161 UNiGLIDE PSP Barrier Envelope Size 1 Phosphor Plates Covers UBE-8162 UNiGLIDE PSP Barrier Envelope Size 2 Phosphor Plates Covers UBE-8050 Standard PSP Barrier Envelope Size 0 Phosphor Plates Covers UBE-8051 Standard PSP Barrier Envelope Size 1 Phosphor Plates Covers UBE-8052 Standard PSP Barrier Envelope Size 2 Phosphor Plates Covers UBE-8053 Standard PSP Barrier Envelope Size 3 Phosphor Plates Covers UBE-8054 Standard PSP Barrier Envelope Size 4 Phosphor Plates Covers UBC-8040-U Keyboard sleeves Computer keyboard, universal, 22"X14" UBC-8040-L Keyboard sleeves Computer keyboard, large, 19"X26" UBC-8041 LCD & Keyboard sleeves Computer screen and keyboard, universal UBC-8042 Laptop sleeves Laptop, universal UBC-8043-S Low-speed contra-angle handpiece sleeves w/paper backing Dental low-speed contra-angle handpiece, universal UBC-8043-L Low-speed long handpiece sleeves w/paper backing Dental low-speed long handpiece, universal UBC-8044 Optical PC mouse barriers Computer mouse, universal UBC-8055 Syringe sleeve w/paper backing Air/water syringe, universal UBC-8048 Barrier film – Blue Covers trays, accessories UBC-8049 Barrier Film - Clear Covers trays, accessories

Source page: https://510kreport.com/device/K183263
Methodology: https://510kreport.com/methodology