Product code EFN
- Device name
- Cotton, Roll
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.6050
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K872810 | STRUNG DENTAL ROLLS | American Silk Sutures, Inc. | 1987-12-04 |
| K871464 | MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STER | Medgroup Enterprises, Inc. | 1987-04-30 |
| K863764 | COTTON ROLLS, NON-STERILE | The Medical Group, Inc. | 1986-10-27 |
| K861338 | DENTAL COTTON ROLLS, STERILE AND NON-STERILE | Intl. Verbandstoff-Fabrik Schaffhau | 1986-08-06 |
| K861727 | COTTON FILLED GAUZE SPONGES 2 X 2 | Cross Country Paper Products Corp. | 1986-07-10 |
| K843539 | TELEDYNE DENSCO DRY TIPS SALIVA ABSORB- | Molnlycke A/S Hospital Products | 1985-05-23 |
| K841327 | DENTAL COTTON ROLLS | Intl. Verbandstoff-Fabrik Schaffhau | 1984-07-03 |
| K834056 | SCHEIN COTTON ROLLS, NON-STERILE | Henry Schein, Inc. | 1984-02-03 |
| K830175 | STERILE COTTON ROLLS #3, 1 1/2 | Veratex Corp. | 1983-02-18 |
| K812709 | STERILE DENTAL ROLL | Medspec Corp. | 1981-10-23 |
| K810830 | HOYT COTTON ROLLS | Hoyt Laboratories | 1981-04-14 |
| K802429 | COTTON ROLLS | Worldwide Surgical Gauze | 1980-10-23 |
| K792391 | COTTON ROLL COMPRESSION CAPS | Parker Laboratories, Inc. | 1979-12-06 |
| K770063 | DISP. ABSORBENT COMPRESSED FIBRE WAFER | Lorvic Corp. | 1977-01-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10304040184865 | Henry Schein | HENRY SCHEIN, INC. | 2024-08-15 |
| 10304040184858 | Henry Schein | HENRY SCHEIN, INC. | 2024-08-15 |
| 10304040184827 | Henry Schein | HENRY SCHEIN, INC. | 2024-08-15 |
| 10304040184810 | Henry Schein | HENRY SCHEIN, INC. | 2024-08-15 |
| 10304040184803 | Henry Schein | HENRY SCHEIN, INC. | 2024-08-15 |
| 10850053289535 | SURGYCO | Surgyco LLC | 2024-08-09 |
| 10850053289542 | SURGYCO | Surgyco LLC | 2024-08-09 |
| 10815878027588 | Burkhart Non-Woven Sponges | CROSSTEX INTERNATIONAL, INC. | 2024-04-09 |
| 10815878028486 | Burkhart Non-Woven Sponges | CROSSTEX INTERNATIONAL, INC. | 2024-04-09 |
| 10815878025324 | Burkhart Non-Woven Sponges | CROSSTEX INTERNATIONAL, INC. | 2024-04-09 |
| 10732224001408 | Cotton Rolls, Non-Sterile, Advantage Plus | CROSSTEX INTERNATIONAL, INC. | 2022-08-25 |
| 10732224000043 | Cotton Rolls | CROSSTEX INTERNATIONAL, INC. | 2022-08-25 |
| 10732224001187 | Crosstex International | CROSSTEX INTERNATIONAL, INC. | 2022-08-25 |
| 10732224001194 | Crosstex International | CROSSTEX INTERNATIONAL, INC. | 2022-08-25 |
| 10732224001361 | Crosstex International | CROSSTEX INTERNATIONAL, INC. | 2022-08-25 |
| 10732224000104 | Cotton Rolls | CROSSTEX INTERNATIONAL, INC. | 2022-08-19 |
| 10817508021300 | Beesure | ASCEND EAGLE INCORPORATED | 2022-05-18 |
| 10304040153625 | Henry Schein | HENRY SCHEIN, INC. | 2021-05-11 |
| 10304040153618 | Henry Schein | HENRY SCHEIN, INC. | 2021-05-11 |
| 10304040153601 | Henry Schein | HENRY SCHEIN, INC. | 2021-05-11 |
| 10304040153588 | Essentials | HENRY SCHEIN, INC. | 2021-05-10 |
| 10304040153724 | Henry Schein | HENRY SCHEIN, INC. | 2021-05-10 |
| 10304040153717 | Henry Schein | HENRY SCHEIN, INC. | 2021-05-10 |
| 10304040153595 | Henry Schein | HENRY SCHEIN, INC. | 2021-05-10 |
| 10195594951962 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2021-03-23 |
| 10885380054136 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-07-10 |
| 10885380054143 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-07-10 |
| 10686864055775 | MEDICOM SAFEBASICS | AMD Medicom Inc | 2019-01-16 |
| 10686864048562 | MEDICOM SAFEBASICS | AMD Medicom Inc | 2019-01-16 |
| 10686864048555 | MEDICOM | AMD Medicom Inc | 2019-01-16 |