MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011

Handpiece, Air-powered, Dental

MK-DENT GMBH

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.

Pre-market Notification Details

• 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

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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