Septocalcine Ultra
FDA 510(k) K920692 · Specialites Septodont
510(k) numberK920692
Submission
- Device name
- Septocalcine Ultra
- Applicant
- Specialites Septodont
Washington, DC, US - Received
- February 14, 1992
- Decision date
- April 21, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K180344 | TheraCal DCEJK · Special | Bisco, Inc. | 04/05/2018SE |
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| K150559 | Life Fast Set, Life Regular SetEJK · Special | Sybron Dental Specialties | 06/19/2015SE |
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| K982773 | Quickset Liquid and PowderEMA · Traditional | 11/03/1998SE |
| K982671 | SecuralloyEJJ · Traditional | 10/19/1998SE |
| K980633 | Endosolv EKIF · Traditional | 05/01/1998SE |
| 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 Septocalcine Ultra cleared by the FDA?
Septocalcine Ultra (K920692) received a 510(k) decision of Substantially Equivalent on April 21, 1992, 67 days after the submission was received.
What is the product code of K920692?
The FDA product code is EJK – Liner, Cavity, Calcium Hydroxide, a Class II (moderate risk) device regulated under 21 CFR 872.3250.