510(k) · Cleared
ClearedPac-Dent Barrier Sleeve, Cover-It (TM) Barrier Film
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pac-Dent International, Inc. · PEM Dental Barriers And Sleeves
Cleared on Mar 3, 2016 as substantially equivalent to K132953 (Tidi Products,Llc, 2014) after a 310-day review. Its family tree reaches back 1 generation to 2014. 9 later devices descend from it.
- Decided
- Mar 3, 2016
- Review
- 310 days
- Class
- Class II
- Product code
- PEM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K132953 (2014). 9 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK132953 TidisheildTidi Products,Llc · 2014
- This deviceK151123 Pac-Dent Barrier Sleeve, Cover-It (TM) Barrier FilmPac-Dent International, Inc. · 2016
- Descendant · cites it directly · 4 of its ownK190484 BH Medical Dental Barrier Sleeves and Barrier FilmBh Medical Products Co., Ltd. · 2019
- Descendant · 2 generations on · 2 of its ownK233918 Dental Barrier and SleevesYongqing Huaguan Dental Instruments Factory · 2024
- Descendant · 2 generations on · 1 of its ownK250606 Dental Barrier and SleevesYueying Medical Instruments (Langfang) Co., Ltd. · 2025
- Descendant · cites it directly · 1 of its ownK163447 Premium Plus Disposable Barrier SleevePremium Plus International Limited · 2017
- Descendant · 3 generations on · 0 of its ownK262073 Hygienic Protective Bite Cover (2207-010-50)Dürr Dental SE · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K190484BH Medical Dental Barrier Sleeves and Barrier FilmBh Medical Products Co., Ltd. · 2019 · cites it directly4descendants
- K233918Dental Barrier and SleevesYongqing Huaguan Dental Instruments Factory · 2024 · 2 generations on2descendants
- K250606Dental Barrier and SleevesYueying Medical Instruments (Langfang) Co., Ltd. · 2025 · 2 generations on1descendant
- K163447Premium Plus Disposable Barrier SleevePremium Plus International Limited · 2017 · cites it directly1descendant
- K262073Hygienic Protective Bite Cover (2207-010-50)Dürr Dental SE · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K132953 | Tidisheild | Tidi Products,Llc | 2014 | — |
| 0 (this device) | K151123 | Pac-Dent Barrier Sleeve, Cover-It (TM) Barrier Film | Pac-Dent International, Inc. | 2016 | — |
| +1 | K190484 | BH Medical Dental Barrier Sleeves and Barrier Film | Bh Medical Products Co., Ltd. | 2019 | — |
| +2 | K233918 | Dental Barrier and Sleeves | Yongqing Huaguan Dental Instruments Factory | 2024 | — |
| +2 | K250606 | Dental Barrier and Sleeves | Yueying Medical Instruments (Langfang) Co., Ltd. | 2025 | — |
| +1 | K163447 | Premium Plus Disposable Barrier Sleeve | Premium Plus International Limited | 2017 | — |
| +3 | K262073 | Hygienic Protective Bite Cover (2207-010-50) | Dürr Dental SE | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K132953 | TidisheildSummary page 5…uct Code: PEM Classification Name: Surgical drape and drape accessories per 21 CFR 878.4370 Predicate Device Primary predicate device: TiDiShield Curing Light Sleeve - K132953 Reference Device: Cover-All, Chair Sleeve, Drape-it-All, Tray Sleeve, related products - K962288 Description of Device… | 2014 |
| † | K962288 | Cover-All, Drape-IT-All, Chair Sleve, X-Ray Sleeve, Headrest Cover | 1997 |
What descends from it? (9)
4 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?
How does its category compare?
All PEM devicesPEM Dental Barriers And Sleeves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
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…
Read the full statement (489 words)
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"
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151123 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151123: Pac-Dent Barrier Sleeve, Cover-It (TM) 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/K151123
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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