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.
| 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810113690087 | K032234 | 000 |
| E490QC5016SW1 | K032234 | 000 |
| E490QC5016NT1 | K032234 | 000 |
| E490QC5016KW1 | K032234 | 000 |
| E490QC5016K1 | K032234 | 000 |
| E490QC5015K1 | K032234 | 000 |
| E490QC4014W1 | K032234 | 000 |
| E490QC4014NT1 | K032234 | 000 |
| E490QC4014K1 | K032234 | 000 |
| E490QC4012K1 | K032234 | 000 |
| E490HP22WL1 | K032234 | 000 |
| E490HP22NL1 | K032234 | 000 |
| E490HP22KL1 | K032234 | 000 |
| E490HP21WL1 | K032234 | 000 |
| E490HP21SL1 | K032234 | 000 |
| E490HP21NL1 | K032234 | 000 |
| E490HP21KL1 | K032234 | 000 |
| E490QC5016W1 | K032234 | 000 |
| E490QC5116K1 | K032234 | 000 |
| E490QC5116KW1 | K032234 | 000 |
| 00810113690070 | K032234 | 000 |
| 00810113690063 | K032234 | 000 |
| 00810113690056 | K032234 | 000 |
| 00810113690049 | K032234 | 000 |
| 00810113690032 | K032234 | 000 |
| 00810113690025 | K032234 | 000 |
| 00810113690018 | K032234 | 000 |
| 00810113690001 | K032234 | 000 |
| 00810113691176 | K032234 | 000 |
| 00810113691169 | K032234 | 000 |
| E490QC6116KW1 | K032234 | 000 |
| E490QC6116K1 | K032234 | 000 |
| E490QC6016SW1 | K032234 | 000 |
| E490QC6016NT1 | K032234 | 000 |
| E490QC6016KW1 | K032234 | 000 |
| E490QC6016K1 | K032234 | 000 |
| E490HE22WL1 | K032234 | 000 |
| E490HE22W1 | K032234 | 000 |
| E490HE121 | K032234 | 000 |
| E490HE111 | K032234 | 000 |
| E490HC8021K1 | K032234 | 000 |
| E490HC22KL1 | K032234 | 000 |
| E490HC22K1 | K032234 | 000 |
| E490HC21KL1 | K032234 | 000 |
| E490HC21K1 | K032234 | 000 |
| E490HC20KL1 | K032234 | 000 |
| E490HC20K1 | K032234 | 000 |
| E490HB23KL1 | K032234 | 000 |
| E490HB23K1 | K032234 | 000 |
| E490HB21KL1 | K032234 | 000 |
| E490HB21K1 | K032234 | 000 |
| E490HB16L1 | K032234 | 000 |
| E490HB15L1 | K032234 | 000 |
| E490HB141 | K032234 | 000 |
| E490HE141 | K032234 | 000 |
| E490HE15L1 | K032234 | 000 |
| E490HE16L1 | K032234 | 000 |
| E490HE22NL1 | K032234 | 000 |
| E490HE22N1 | K032234 | 000 |
| E490HE22KL1 | K032234 | 000 |
| E490HE22K1 | K032234 | 000 |
| E490HE21WL1 | K032234 | 000 |
| E490HE21W1 | K032234 | 000 |
| E490HE21SL1 | K032234 | 000 |
| E490HE21NL1 | K032234 | 000 |
| E490HE21N1 | K032234 | 000 |
| E490HE21KL1 | K032234 | 000 |
| E490HE21K1 | K032234 | 000 |
| E490HE20KL1 | K032234 | 000 |
| E490HE20K1 | K032234 | 000 |
| E490HE181 | K032234 | 000 |
| E490HE17B1 | K032234 | 000 |
| E490HE171 | K032234 | 000 |
| E490HB121 | K032234 | 000 |
| 04050546151625 | K032234 | 000 |
| 04050546002484 | K032234 | 000 |
| 04050546002446 | K032234 | 000 |
| 04050546002439 | K032234 | 000 |
| 04050546002422 | K032234 | 000 |
| 04050546002415 | K032234 | 000 |
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| 04050546001494 | K032234 | 000 |
| 04050546001487 | K032234 | 000 |
| 04050546001395 | K032234 | 000 |
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| 04050546002521 | K032234 | 000 |
| 04050546151526 | K032234 | 000 |
| 04050546141428 | K032234 | 000 |
| 04050546003948 | K032234 | 000 |
| 04050546003931 | K032234 | 000 |
| 04050546003924 | K032234 | 000 |
| 04050546003917 | K032234 | 000 |
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| 04050546003849 | K032234 | 000 |
| 04050546003825 | K032234 | 000 |
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| 04050546003771 | K032234 | 000 |
| 04050546003765 | K032234 | 000 |
| 04050546003740 | K032234 | 000 |
| 04050546003733 | K032234 | 000 |
| 04050546001364 | K032234 | 000 |
| 04050546001357 | K032234 | 000 |
| 04050546000015 | K032234 | 000 |
| D884QC6016K0 | K032234 | 000 |
| D884QC4014K0 | K032234 | 000 |
| D884LE15L00 | K032234 | 000 |
| D884LE1100 | K032234 | 000 |
| D884LCH1100 | K032234 | 000 |
| 00810113690193 | K032234 | 000 |
| 00810113690186 | K032234 | 000 |
| 00810113690179 | K032234 | 000 |
| 00810113690162 | K032234 | 000 |
| 00810113690155 | K032234 | 000 |
| 00810113690148 | K032234 | 000 |
| 00810113690131 | K032234 | 000 |
| 00810113690124 | K032234 | 000 |
| 00810113690117 | K032234 | 000 |
| 00810113690100 | K032234 | 000 |
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| 04050546001319 | K032234 | 000 |
| 04050546001302 | K032234 | 000 |
| 04050546001296 | K032234 | 000 |
| 04050546001241 | K032234 | 000 |
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| 04050546000893 | K032234 | 000 |
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| 04050546000879 | K032234 | 000 |
| 04050546000862 | K032234 | 000 |
| 04050546000145 | K032234 | 000 |
| 04050546000077 | K032234 | 000 |
| 04050546000060 | K032234 | 000 |
| 00810113690094 | K032234 | 000 |