Clean & More
FDA 510(k) clearance K151748 · decided 2016-03-11
Clearance details
- K-number
- K151748
- Device name
- Clean & More
- Applicant
- 3M Deutschland GmbH
- Decision
- Substantially Equivalent
- Date received
- 2015-06-29
- Decision date
- 2016-03-11
- Days to decision
- 256 days
- Clearance type
- Traditional
- Product code
- PIP
- Device class
- 2
- Regulation number
- 872.6080
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Seefeld, DE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CLINPRO PROPHY POWDER (K140684) | 3M Deutschland GmbH | 2014-10-24 |
Recalls involving this device
No recalls on record reference this clearance.