Amalgamator
FDA 510(k) K880993 · Acecodent, Inc.
510(k) numberK880993
Submission
- Device name
- Amalgamator
- Applicant
- Acecodent, Inc.
Flushing, NY, US - Received
- March 8, 1988
- Decision date
- May 11, 1988
- 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 |
Questions and answers
When was Amalgamator cleared by the FDA?
Amalgamator (K880993) received a 510(k) decision of Substantially Equivalent on May 11, 1988, 64 days after the submission was received.
What is the product code of K880993?
The FDA product code is EFD – Amalgamator, Dental, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 872.3100.