Cotton, Roll
The Cotton Roll is a dental device consisting of a cylindrical roll of absorbent cotton used to isolate teeth from saliva, retract soft tissues, and maintain a dry field during dental procedures. It is classified as FDA Class 1, the lowest risk category, and is GMP exempt, meaning it is also exempt from most good manufacturing practice requirements. The product code is EFN and the applicable regulation is 21 CFR 872.6050, under the Dental medical specialty.
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Basic Information
- Product Code
- EFN
- Device Class
- FDA class 1
- Regulation Number
- 872.6050
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K872810 | STRUNG DENTAL ROLLS | Dec 04, 1987 | Substantially Equivalent | American Silk Sutures, Inc. |
| K871464 | MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STER | Apr 30, 1987 | Substantially Equivalent | Medgroup Enterprises, Inc. |
| K863764 | COTTON ROLLS, NON-STERILE | Oct 27, 1986 | Substantially Equivalent | The Medical Group, Inc. |
| K861338 | DENTAL COTTON ROLLS, STERILE AND NON-STERILE | Aug 06, 1986 | Substantially Equivalent | Intl. Verbandstoff-Fabrik Schaffhau |
| K861727 | COTTON FILLED GAUZE SPONGES 2 X 2 | Jul 10, 1986 | Substantially Equivalent | Cross Country Paper Products Corp. |
| K843539 | TELEDYNE DENSCO DRY TIPS SALIVA ABSORB- | May 23, 1985 | Substantially Equivalent | Molnlycke A/S Hospital Products |
| K841327 | DENTAL COTTON ROLLS | Jul 03, 1984 | Substantially Equivalent | Intl. Verbandstoff-Fabrik Schaffhau |
| K834056 | SCHEIN COTTON ROLLS, NON-STERILE | Feb 03, 1984 | Substantially Equivalent | Henry Schein, Inc. |
| K830175 | STERILE COTTON ROLLS #3, 1 1/2 | Feb 18, 1983 | Substantially Equivalent | Veratex Corp. |
| K812709 | STERILE DENTAL ROLL | Oct 23, 1981 | Substantially Equivalent | Medspec Corp. |
| K810830 | HOYT COTTON ROLLS | Apr 14, 1981 | Substantially Equivalent | Hoyt Laboratories |
| K802429 | COTTON ROLLS | Oct 23, 1980 | Substantially Equivalent | Worldwide Surgical Gauze |
| K792391 | COTTON ROLL COMPRESSION CAPS | Dec 06, 1979 | Substantially Equivalent | Parker Laboratories, Inc. |
| K770063 | DISP. ABSORBENT COMPRESSED FIBRE WAFER | Jan 14, 1977 | Substantially Equivalent | Lorvic Corp. |
FEI Numbers
This FDA classification entry is associated with 206 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 206 registration numbers. Click on an entry to view related FDA registrations.