EFN · Cotton, Roll
Dental · 21 CFR 872.6050 · Class 1
Overview
| Product Code | EFN |
|---|---|
| Device Name | Cotton, Roll |
| Regulation | 21 CFR 872.6050 |
| Device Class | Class 1 |
| Review Panel | Dental |
| GMP Exempt | Yes |
Identification
A saliva absorber is a device made of paper or cotton intended to absorb moisture from the oral cavity during dental procedures.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (14 of 14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K872810 | STRUNG DENTAL ROLLS | American Silk Sutures, Inc. | Dec 4, 1987 | SESE |
| K871464 | MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STER | Medgroup Enterprises, Inc. | Apr 30, 1987 | SESE |
| K863764 | COTTON ROLLS, NON-STERILE | The Medical Group, Inc. | Oct 27, 1986 | SESE |
| K861338 | DENTAL COTTON ROLLS, STERILE AND NON-STERILE | Intl. Verbandstoff-Fabrik Schaffhau | Aug 6, 1986 | SESE |
| K861727 | COTTON FILLED GAUZE SPONGES 2 X 2 | Cross Country Paper Products Corp. | Jul 10, 1986 | SESE |
| K843539 | TELEDYNE DENSCO DRY TIPS SALIVA ABSORB- | Molnlycke A/S Hospital Products | May 23, 1985 | SESE |
| K841327 | DENTAL COTTON ROLLS | Intl. Verbandstoff-Fabrik Schaffhau | Jul 3, 1984 | SESE |
| K834056 | SCHEIN COTTON ROLLS, NON-STERILE | Henry Schein, Inc. | Feb 3, 1984 | SESE |
| K830175 | STERILE COTTON ROLLS #3, 1 1/2 | Veratex Corp. | Feb 18, 1983 | SESE |
| K812709 | STERILE DENTAL ROLL | Medspec Corp. | Oct 23, 1981 | SESE |
| K810830 | HOYT COTTON ROLLS | Hoyt Laboratories | Apr 14, 1981 | SESE |
| K802429 | COTTON ROLLS | Worldwide Surgical Gauze | Oct 23, 1980 | SESE |
| K792391 | COTTON ROLL COMPRESSION CAPS | Parker Laboratories, Inc. | Dec 6, 1979 | SESE |
| K770063 | DISP. ABSORBENT COMPRESSED FIBRE WAFER | Lorvic Corp. | Jan 14, 1977 | SESE |
Top Applicants
- Intl. Verbandstoff-Fabrik Schaffhau — 2 clearances
- American Silk Sutures, Inc. — 1 clearance
- Cross Country Paper Products Corp. — 1 clearance
- Henry Schein, Inc. — 1 clearance
- Hoyt Laboratories — 1 clearance
