Drilling Machine W/Handpieces & Internal Irriga.
FDA 510(k) K891612 · Implant Innovations International, Inc.
510(k) numberK891612
Submission
- Device name
- Drilling Machine W/Handpieces & Internal Irriga.
- Applicant
- Implant Innovations International, Inc.
West Palm Beach, FL, US - Received
- March 20, 1989
- Decision date
- June 12, 1989
- 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 |
| K891064 | Espe CapmixEFD · Traditional | Espe GmbH (Us) | 05/30/1989SE |
More from Espe GmbH (Us)
| 510(k) | Device | Decision |
|---|---|---|
| K935544 | 3I Standard Threaded/Self-Tapping Threaded Implants ModificationDZE · Traditional | 03/13/1995SE |
| K932123 | Implant Innovation Pre-Angled Abutment SystemDZE · Traditional | 05/27/1994SE |
| K911655 | ImplaretteEKJ · Traditional | 10/21/1991SE |
| K905303 | Abutment GloEJR · Traditional | 06/10/1991SE |
| K911701 | G-Floss & G-Floss IIJES · Traditional | 05/15/1991SE |
| K891613 | Overdenture AttachmentDZE · Traditional | 10/10/1989SE |
| K891617 | Insertion ToolsDZE · Traditional | 05/01/1989SE |
| K891618 | Titanium ForcepsDZE · Traditional | 04/17/1989SE |
| K891615 | Surgical DrillsDZE · Traditional | 04/17/1989SE |
| K874590 | Innovative Implants and Cover ScrewsDZE · Traditional | 05/11/1988SE |
Questions and answers
When was Drilling Machine W/Handpieces & Internal Irriga. cleared by the FDA?
Drilling Machine W/Handpieces & Internal Irriga. (K891612) received a 510(k) decision of Substantially Equivalent on June 12, 1989, 84 days after the submission was received.
What is the product code of K891612?
The FDA product code is EFD – Amalgamator, Dental, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 872.3100.