Resolve 2.0
FDA 510(k) clearance K152322 · decided 2015-12-16
Clearance details
- K-number
- K152322
- Device name
- Resolve 2.0
- Applicant
- Denali Corporation
- Decision
- Substantially Equivalent
- Date received
- 2015-08-17
- Decision date
- 2015-12-16
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- PME
- Device class
- 2
- Regulation number
- 872.3260
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Hanover, MA, 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 |
| CeraClean (K163171) | Bisco, Inc. | 2017-04-14 |
Recalls involving this device
No recalls on record reference this clearance.