MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K
FDA 510(k) clearance K032234 · decided 2003-10-02
Clearance details
- K-number
- K032234
- Device name
- MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K
- Applicant
- Mk-Dent GmbH
- Decision
- Substantially Equivalent
- Date received
- 2003-07-21
- Decision date
- 2003-10-02
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- EFB
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Kumhausen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.