Mk-Dent High Speed Dental Handpiece, Models HS 4021K, 4011K, 4012K, and HS 6021K, 6011K, 6012K
FDA 510(k) K032234 · Mk-Dent GmbH
510(k) numberK032234
Submission
- Device name
- Mk-Dent High Speed Dental Handpiece, Models HS 4021K, 4011K, 4012K, and HS 6021K, 6011K, 6012K
- Applicant
- Mk-Dent GmbH
Kumhausen, DE - Received
- July 21, 2003
- Decision date
- October 2, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Ttbio Corp.
| 510(k) | Device | Decision |
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| K051872 | Mk-Dent Low Speed Handpieces and Accessories Including Spare Parts, Tubings, and Light…EFB · Traditional | 10/03/2005SE |
Questions and answers
When was Mk-Dent High Speed Dental Handpiece, Models HS 4021K, 4011K, 4012K, and HS 6021K, 6011K, 6012K cleared by the FDA?
Mk-Dent High Speed Dental Handpiece, Models HS 4021K, 4011K, 4012K, and HS 6021K, 6011K, 6012K (K032234) received a 510(k) decision of Substantially Equivalent on October 2, 2003, 73 days after the submission was received.
What is the product code of K032234?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.