Rocatec(R) -Plus
FDA 510(k) K913857 · Espe GmbH (Us)
510(k) numberK913857
Submission
- Device name
- Rocatec(R) -Plus
- Applicant
- Espe GmbH (Us)
West Germany, DE - Received
- August 27, 1991
- Decision date
- December 16, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from American Dent-All, Inc.
| 510(k) | Device | Decision |
|---|---|---|
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| K913966 | Sono(R) -CemEBF · Traditional | 01/14/1992SE |
| K913965 | Espe(R) -SilKLE · Traditional | 12/04/1991SE |
| K905604 | Visio-Gem Art-SystemEBF · Traditional | 03/29/1991SE |
| K904096 | Photac-BondEJK · Traditional | 11/19/1990SE |
| K904097 | Photac-Bond AplicapEJK · Traditional | 11/09/1990SE |
| K904289 | Pertac Universal BondKLE · Traditional | 11/01/1990SE |
| K900510 | Pertac-HybridEBF · Traditional | 08/09/1990SE |
| K900558 | Pertac BondKLE · Traditional | 04/10/1990SE |
Questions and answers
When was Rocatec(R) -Plus cleared by the FDA?
Rocatec(R) -Plus (K913857) received a 510(k) decision of Substantially Equivalent on December 16, 1991, 111 days after the submission was received.
What is the product code of K913857?
The FDA product code is EJH – Alloy, Metal, Base, a Class II (moderate risk) device regulated under 21 CFR 872.3710.