Definition: Intended To Serve As A Disposable Barrier For Dental Instruments To Reduce The Risk Of Cross Contamination Between Dental Patients.
| Device Type ID | 1398 |
| Device Name | Dental Barriers And Sleeves |
| Physical State | Clear Polymer Film |
| Technical Method | Adhesively Applied To Patient Contacting Surfaces Of Reusable Dental Instruments/devices. |
| Target Area | For Devices To Be Used In Dental Surgery. |
| Regulation Description | Surgical Drape And Drape Accessories. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | Dental |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4370 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PEM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1398 |
| Device | Dental Barriers And Sleeves |
| Product Code | PEM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Drape And Drape Accessories. |
| CFR Regulation Number | 878.4370 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DENTSPLY INTERNATIONAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENTSPLY TULSA DENTAL SPECIALTIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PAC-DENT INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PREMIUM PLUS INTERNATIONAL LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TIDI PRODUCTS, LLC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |