Endosolv E
FDA 510(k) K980633 · Specialites Septodont
510(k) numberK980633
Submission
- Device name
- Endosolv E
- Applicant
- Specialites Septodont
Washington, DC, US - Received
- February 19, 1998
- Decision date
- May 1, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K982671 | SecuralloyEJJ · Traditional | 10/19/1998SE |
| K920692 | Septocalcine UltraEJK · Traditional | 04/21/1992SE |
| K915467 | Cimpat S Dental CementEMA · Traditional | 02/03/1992SE |
| K915466 | Septopack Temporary FillingEBG · Traditional | 02/03/1992SE |
| K913573 | Safety Plus Dental Injection NeedleDZM · Traditional | 11/07/1991SE |
| K913572 | Autopack Non-Eugenol Periodontal DressingEMA · Traditional | 10/09/1991SE |
| K913574 | Septocal Cavity LinerEJK · Traditional | 09/30/1991SE |
Questions and answers
When was Endosolv E cleared by the FDA?
Endosolv E (K980633) received a 510(k) decision of Substantially Equivalent on May 1, 1998, 71 days after the submission was received.
What is the product code of K980633?
The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.