MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K

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 High Speed Dental Handpiece, Models Hs 4021k, 4011k, 4012k, And Hs 6021k, 6011k, 6012k.

Pre-market Notification Details

• Device ID: K032234
• 510k Number: K032234
• Device Name: MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K
• 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: 2003-07-21
• Decision Date: 2003-10-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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