The following data is part of a premarket notification filed by Mk-dent Gmbh with the FDA for Mk-dent Low Speed Handpieces And Accessories Including Spare Parts, Tubings, And Light Power System, Models: Ls2011.
Device ID | K051872 |
510k Number | K051872 |
Device Name: | MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011 |
Classification | Handpiece, Air-powered, Dental |
Applicant | MK-DENT GMBH EISENHUTWEG 15 Kumhausen-preisenberg, DE 84036 |
Contact | Martina Gunderoth |
Correspondent | Martina Gunderoth MK-DENT GMBH EISENHUTWEG 15 Kumhausen-preisenberg, DE 84036 |
Product Code | EFB |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-07-11 |
Decision Date | 2005-10-03 |
Summary: | summary |