Racestyptine Rings
FDA 510(k) K761024 · Septodont, Inc.
510(k) numberK761024
Submission
- Device name
- Racestyptine Rings
- Applicant
- Septodont, Inc.
Mchenry, IL, US - Received
- September 15, 1976
- Decision date
- November 19, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EIG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971284 | OpaldamEIG · Traditional | Ultradent Products, Inc. | 06/03/1997SE |
| K854711 | Fibrelight Illuminating Oral RetractorsEIG · Traditional | Downs Surgical , Ltd. | 02/25/1986SE |
| K832366 | Zoller Burned Lip ConformerEIG · Traditional | Universal Prosthetics, Inc. | 09/26/1983SE |
| K821784 | Beach Gingival Retraction Instr. Type BEIG · Traditional | Pacific Dental Corp. | 07/06/1982SE |
| K771973 | GingitractEIG · Traditional | Den-Mat Corp. | 11/07/1977SE |
| K771399 | Lip & Cheek RetractorEIG · Traditional | L.D. Caulk Co. | 08/26/1977SE |
| K760657 | Racestyptine CordEIG · Traditional | Septodont, Inc. | 09/27/1976SE |
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| K172839 | EndosolvKIF · Traditional | 02/13/2018SE |
| K140132 | BiodentineKIF · Traditional | 06/27/2014SE |
| K093711 | RacegelMVL · Traditional | 02/17/2010SE |
| K092251 | BiodentineKIF · Traditional | 10/30/2009SE |
| K063634 | RTR SyringeLYC · Abbreviated | 05/11/2007SE |
| K051010 | Securalloy, Septalloy NG 50 and Septalloy NG 70EJJ · Special | 05/02/2005SE |
| K032708 | Plastalgin and Plastalgin OrthoELW · Traditional | 11/20/2003SE |
| K780003 | Endosolv EKJJ · Traditional | 01/20/1978SE |
Questions and answers
When was Racestyptine Rings cleared by the FDA?
Racestyptine Rings (K761024) received a 510(k) decision of Substantially Equivalent on November 19, 1976, 65 days after the submission was received.
What is the product code of K761024?
The FDA product code is EIG – Retractor, All Types, a Class I (low risk) device regulated under 21 CFR 872.4565.