| Device Type ID | 1154 |
| Device Name | Cotton, Roll |
| Regulation Description | Saliva Absorber. |
| Regulation Medical Specialty | Dental |
| 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) Exempt |
| CFR Regulation Number | 872.6050 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | EFN |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1154 |
| Device | Cotton, Roll |
| Product Code | EFN |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Saliva Absorber. |
| CFR Regulation Number | 872.6050 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 2 |
Appropriate Term/Code Not Available | 1 |
Product Quality Problem | 1 |
Nonstandard Device | 1 |
| Total Device Problems | 5 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | American Surgical Company | II | May-26-2016 |