510(k) · Cleared
ClearedUNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unipack Medical Corporation · PEM Dental Barriers And Sleeves
Cleared on Jun 14, 2019 as substantially equivalent to K151123 (Pac-Dent International, Inc., 2016) after a 203-day review. Its family tree reaches back 2 generations to 2014.
- Decided
- Jun 14, 2019
- Review
- 203 days
- Class
- Class II
- Product code
- PEM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K132953 (2014). No later device cites it as a predicate yet.
- 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 deviceK183263 UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier EnvelopeUnipack Medical Corporation · 2019
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) | K183263 | UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope | Unipack Medical Corporation | 2019 | — |
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 6…ate Device: Company: Pac-Dent International Inc. Device: Pac-Dent Barrier Sleeve, Cover-It™ Barrier Film 510(k): K151123 Date Cleared: March 3, 2016 1.1 Device Description: The UNiPACK Barrier Sleeve and Barrier Film consist of… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 3.3 years on median.
- None of the 2 ancestors has a recall.
- 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?
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"…
Read the full statement (607 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183263 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183263: UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183263
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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