MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011
FDA 510(k) clearance K051872 · decided 2005-10-03
Clearance details
- K-number
- K051872
- Device name
- MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011
- Applicant
- Mk-Dent GmbH
- Decision
- Substantially Equivalent
- Date received
- 2005-07-11
- Decision date
- 2005-10-03
- Days to decision
- 84 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.