Capmix
FDA 510(k) K771901 · Espe Dental Products
510(k) numberK771901
Submission
- Device name
- Capmix
- Applicant
- Espe Dental Products
Mchenry, IL, US - Received
- October 7, 1977
- Decision date
- October 20, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EFD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K991913 | Pentamix 2EFD · Traditional | Espe Dental AG | 07/26/1999SE |
| K923974 | Silimat PlusEFD · Traditional | Ivoclar North America, Inc. | 10/06/1992SE |
| K922203 | Ipt Capsule MixerEFD · Traditional | Ipt Technologies, Inc. | 06/03/1992SE |
| K915847 | Automix Dental AmalgamatorEFD · Traditional | Kerr Corporation (Danbury) | 03/02/1992SE |
| K914341 | Mixomat AmalgamatorEFD · Traditional | Degussa AG | 11/13/1991SE |
| K914340 | Duomat 3 AmalgamatorEFD · Traditional | Degussa AG | 11/13/1991SE |
| K914339 | Dentomat 3 AmalgamatorsEFD · Traditional | Degussa AG | 11/07/1991SE |
| K910632 | Accu-Mix AmalgamatorEFD · Traditional | Wykle Research, Inc. | 03/15/1991SE |
| K901909 | Silamat (Amalgamator)EFD · Traditional | Ivoclar North America, Inc. | 06/22/1990SE |
| K891612 | Drilling Machine W/Handpieces & Internal Irriga.EFD · Traditional | Implant Innovations International, Inc. | 06/12/1989SE |
More from Implant Innovations International, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K810950 | Visio-SealEBC · Traditional | 04/29/1981SE |
| K802819 | Ketac-Cem in Ref. to K802048EMA · Traditional | 11/24/1980SE |
| K802049 | Nimetic-DispersEBF · Traditional | 09/16/1980SE |
| K800031 | Permadyne Polyether Rubber ImpressionELW · Traditional | 02/05/1980SE |
| K771889 | UnioliteEBZ · Traditional | 10/20/1977SE |
| K771120 | Impreflex Alginate Impression MaterialLEW · Traditional | 08/03/1977SE |
| K771119 | Pastes, Restorative & Tinted, DebtalEBF · Traditional | 07/15/1977SE |
Questions and answers
When was Capmix cleared by the FDA?
Capmix (K771901) received a 510(k) decision of Substantially Equivalent on October 20, 1977, 13 days after the submission was received.
What is the product code of K771901?
The FDA product code is EFD – Amalgamator, Dental, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 872.3100.