Sterile Dental Roll
FDA 510(k) K812709 · Medspec Corp.
510(k) numberK812709
Submission
- Device name
- Sterile Dental Roll
- Applicant
- Medspec Corp.
Mchenry, IL, US - Received
- September 24, 1981
- Decision date
- October 23, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EFN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K872810 | Strung Dental RollsEFN · Traditional | American Silk Sutures, Inc. | 12/04/1987SE |
| K871464 | Medgroup Enterprises Cotton Gauze Sponges-Non SterEFN · Traditional | Medgroup Enterprises, Inc. | 04/30/1987SE |
| K863764 | Cotton Rolls, Non-SterileEFN · Traditional | The Medical Group, Inc. | 10/27/1986SE |
| K861338 | Dental Cotton Rolls, Sterile and Non-SterileEFN · Traditional | Intl. Verbandstoff-Fabrik Schaffhau | 08/06/1986SE |
| K861727 | Cotton Filled Gauze Sponges 2 X 2EFN · Traditional | Cross Country Paper Products Corp. | 07/10/1986SE |
| K843539 | Teledyne Densco Dry Tips Saliva Absorb-EFN · Traditional | Molnlycke A/S Hospital Products | 05/23/1985SE |
| K841327 | Dental Cotton RollsEFN · Traditional | Intl. Verbandstoff-Fabrik Schaffhau | 07/03/1984SE |
| K834056 | Schein Cotton Rolls, Non-SterileEFN · Traditional | Henry Schein, Inc. | 02/03/1984SE |
| K830175 | Sterile Cotton Rolls #3, 1 1/2EFN · Traditional | Veratex Corp. | 02/18/1983SE |
| K810830 | Hoyt Cotton RollsEFN · Traditional | Hoyt Laboratories | 04/14/1981SE |
More from Hoyt Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K813012 | Sterile Basin SetsLDQ · Traditional | 11/06/1981SE |
| K812711 | Sterile Gauze Pads 12PLYNAB · Traditional | 11/02/1981SE |
| K812710 | Sterile Laparotomy Sponges-X-Ray DetectGDY · Traditional | 11/02/1981SE |
| K812707 | Sterile Dissector Sponges-X-Ray DetectGDY · Traditional | 11/02/1981SE |
| K810071 | Sterile Silicone TubingGBS · Traditional | 02/12/1981SE |
| K810069 | Sterile AirwayCAE · Traditional | 02/02/1981SE |
| K802060 | Sterile Tonsil SpongesGDY · Traditional | 10/10/1980SE |
| K801069 | Sterile Isolation GownFYC · Traditional | 05/20/1980SE |
| K801068 | Sterile Abdominal PadKKX · Traditional | 05/20/1980SE |
| K800279 | Medspec Rubber Bands · Traditional | 05/02/1980SE |
Questions and answers
When was Sterile Dental Roll cleared by the FDA?
Sterile Dental Roll (K812709) received a 510(k) decision of Substantially Equivalent on October 23, 1981, 29 days after the submission was received.
What is the product code of K812709?
The FDA product code is EFN – Cotton, Roll, a Class I (low risk) device regulated under 21 CFR 872.6050.