Product code PEM
- Device name
- Dental Barriers And Sleeves
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4370
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250735 | Dental Barrier and Sleeves | Fomed Industries, Inc. | 2025-06-10 |
| K250606 | Dental Barrier and Sleeves | Yueying Medical Instruments (Langfang) Co., Ltd. | 2025-05-29 |
| K242435 | Dental Barrier and Sleeves | Wellmed Dental Medical Supply Co., Ltd. | 2024-10-18 |
| K233918 | Dental Barrier and Sleeves | Yongqing Huaguan Dental Instruments Factory | 2024-05-09 |
| K220662 | Disposable Barrier Sleeves | Premium Plus (Dongguan) Limited | 2022-05-11 |
| K211026 | Minitube Dentasleeve Protective Barrier Sleeves | Minitube AB | 2021-08-03 |
| K201604 | Plasdent Disposable Barrier Sleeves and Barrier Film | Plasdent Corporation | 2020-12-23 |
| K191448 | Barrier Sleeves | Ivoclar Vivadent, AG | 2019-10-08 |
| K190484 | BH Medical Dental Barrier Sleeves and Barrier Film | Bh Medical Products Co., Ltd. | 2019-09-10 |
| K190949 | ScanX Barrier Envelopes | Air Techniques, Inc. | 2019-07-26 |
| K183263 | UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope | Unipack Medical Corporation | 2019-06-14 |
| K163447 | Premium Plus Disposable Barrier Sleeve | Premium Plus International Limited | 2017-06-20 |
| K160232 | Disposable Barrier Sleeves and Covers | Dentsply International, Inc. | 2016-06-07 |
| K151123 | Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film | Pac-Dent International, Inc. | 2016-03-03 |
| K132953 | TIDISHEILD | Tidi Products,Llc | 2014-02-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10618125192301 | Carina | TIDI PRODUCTS, LLC | 2025-09-22 |
| 10304040186722 | Acclean | HENRY SCHEIN, INC. | 2024-10-02 |
| 10371347011958 | Advance Dental Products | The Atlanta Dental Supply Company | 2024-01-04 |
| 10371347011941 | Advance Dental Products | The Atlanta Dental Supply Company | 2024-01-04 |
| 10665973029372 | Unipack | Dukal LLC | 2022-12-06 |
| 10810063752009 | Safco SafeWrap Tray Sleeves | SAFCO DENTAL SUPPLY CO. | 2022-12-02 |
| 10810063751996 | Safco SafeWrap Basics Syringe Sleeves | SAFCO DENTAL SUPPLY CO. | 2022-12-02 |
| 10810063751972 | Safco SafeWrap Chair Sleeves | SAFCO DENTAL SUPPLY CO. | 2022-12-02 |
| 10810063751965 | Safco SafeWrap Chair Sleeves | SAFCO DENTAL SUPPLY CO. | 2022-12-02 |
| 10810063751927 | Safco SafeWrap Curing Light Sleeves | SAFCO DENTAL SUPPLY CO. | 2022-12-02 |
| 10850455007454 | Advance Dental Products | The Atlanta Dental Supply Company | 2021-07-26 |
| 10843717102721 | Midway Select | MIDWAY DENTAL SUPPLY, LLC | 2019-07-19 |
| 10843717102547 | Midway Select | MIDWAY DENTAL SUPPLY, LLC | 2019-07-19 |
| 10302732958312 | Barrier Sleeve, Young Infinity Cordless Handpiece, 500ct | YOUNG DENTAL MANUFACTURING I, LLC | 2018-05-25 |
| 10302732958305 | Barrier Sleeve, Young Infinity Cordless Handpiece, 25ct | YOUNG DENTAL MANUFACTURING I, LLC | 2018-05-25 |
| 10302736704502 | Low Speed Handpiece Sleeve | YOUNG DENTAL MANUFACTURING I, LLC | 2017-10-27 |
| 10302736703505 | Light Handle Sleeve | YOUNG DENTAL MANUFACTURING I, LLC | 2017-10-27 |
| 10302736702508 | Short Pen Sleeve | YOUNG DENTAL MANUFACTURING I, LLC | 2017-10-27 |
| 10302736701501 | Narrow Scaler Sleeve | YOUNG DENTAL MANUFACTURING I, LLC | 2017-10-27 |
| 10304040040550 | Henry Schein | HENRY SCHEIN, INC. | 2017-03-30 |
| 10304040040635 | Henry Schein | HENRY SCHEIN, INC. | 2017-03-30 |
| 10304040040659 | Henry Schein | HENRY SCHEIN, INC. | 2017-03-30 |
| 10304040035730 | Henry Schein | HENRY SCHEIN, INC. | 2016-09-24 |
| 10304040035723 | Henry Schein Essentials | HENRY SCHEIN, INC. | 2016-09-24 |
| 10304040035716 | Henry Schein Essentials | HENRY SCHEIN, INC. | 2016-09-24 |
| 10304040035709 | Henry Schein Essentials | HENRY SCHEIN, INC. | 2016-09-24 |
| 10304040035693 | Henry Schein Essentials | HENRY SCHEIN, INC. | 2016-09-24 |
| 10304040035686 | Henry Schein Essentials | HENRY SCHEIN, INC. | 2016-09-24 |
| 10304040035679 | Henry Schein Essentials | HENRY SCHEIN, INC. | 2016-09-24 |
| 10304040035662 | Henry Schein Essentials | HENRY SCHEIN, INC. | 2016-09-24 |