CeraClean
FDA 510(k) clearance K163171 · decided 2017-04-14
Clearance details
- K-number
- K163171
- Device name
- CeraClean
- Applicant
- Bisco, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-11-14
- Decision date
- 2017-04-14
- Days to decision
- 151 days
- Clearance type
- Traditional
- Product code
- PME
- Device class
- 2
- Regulation number
- 872.3260
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Schaumburg, IL, US
- 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 |
|---|---|---|
| KATANA Cleaner, KATANA Cleaner (Trial) (K191133) | Kuraray Noritake Dental, Inc. | 2019-10-08 |
| Resolve 2.0 (K152322) | Denali Corporation | 2015-12-16 |
Recalls involving this device
No recalls on record reference this clearance.