Pentamix 2

FDA 510(k) K991913 · Espe Dental AG

Substantially Equivalent

510(k) numberK991913

Submission

Device name
Pentamix 2
Applicant
Espe Dental AG
Bavaria D-82228 Seefeld, DE
Received
June 7, 1999
Decision date
July 26, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EFD – Amalgamator, Dental, Ac-Powered
Device class
Class I (low risk)
Regulation
21 CFR 872.3100
Specialty
Dental

Other 510(k)s with product code EFD

510(k)DeviceApplicantDecision
K923974Silimat PlusEFD · Traditional Ivoclar North America, Inc.10/06/1992SE
K922203Ipt Capsule MixerEFD · Traditional Ipt Technologies, Inc.06/03/1992SE
K915847Automix Dental AmalgamatorEFD · Traditional Kerr Corporation (Danbury)03/02/1992SE
K914341Mixomat AmalgamatorEFD · Traditional Degussa AG11/13/1991SE
K914340Duomat 3 AmalgamatorEFD · Traditional Degussa AG11/13/1991SE
K914339Dentomat 3 AmalgamatorsEFD · Traditional Degussa AG11/07/1991SE
K910632Accu-Mix AmalgamatorEFD · Traditional Wykle Research, Inc.03/15/1991SE
K901909Silamat (Amalgamator)EFD · Traditional Ivoclar North America, Inc.06/22/1990SE
K891612Drilling Machine W/Handpieces & Internal Irriga.EFD · Traditional Implant Innovations International, Inc.06/12/1989SE
K891064Espe CapmixEFD · Traditional Espe GmbH (Us)05/30/1989SE

More from Espe GmbH (Us)

510(k)DeviceDecision
K011394Lava Frame, Lava Frame Shade, Lava CeramEIH · Traditional 06/29/2001SE
K011154Elipar FreelightEBZ · Traditional 05/16/2001SE
K002793Ketac Cem UEMA · Special 09/26/2000SE
K002364Protemp HEBG · Special 08/10/2000SE
K001494Modification to Prompt L-PopKLE · Traditional 07/07/2000SE
K000595Dimension Penta LELW · Traditional 04/05/2000SE
K000591Dimension Penta H, Dimension Penta H QuickELW · Traditional 03/30/2000SE
K000588Dimension Garant L, Dimension Garant L QuickELW · Traditional 03/30/2000SE
K994193Impregum Penta DuosoftELW · Traditional 01/28/2000SE
K994192Impregum Penta M MonosoftELW · Traditional 01/28/2000SE

Questions and answers

When was Pentamix 2 cleared by the FDA?

Pentamix 2 (K991913) received a 510(k) decision of Substantially Equivalent on July 26, 1999, 49 days after the submission was received.

What is the product code of K991913?

The FDA product code is EFD – Amalgamator, Dental, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 872.3100.