PS System
FDA 510(k) clearance K211721 · decided 2021-12-02
Clearance details
- K-number
- K211721
- Device name
- PS System
- Applicant
- Inter-Med, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-06-04
- Decision date
- 2021-12-02
- Days to decision
- 181 days
- Clearance type
- Traditional
- Product code
- NYL
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Racine, WI, 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 |
|---|---|---|
| EndoVac Pure (K162436) | Kerr Corporation | 2016-12-21 |
| ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM (K140685) | Sybron Endo | 2014-07-02 |
| VATEA ENDONTIC IRRIGATION SYSTEM (K100606) | Redent Nova, Ltd. | 2010-05-28 |
| RINSENDO (K052271) | Air Techniques, Inc. | 2006-05-26 |
Recalls involving this device
No recalls on record reference this clearance.