OpenSensorX Series
FDA 510(k) clearance K220556 · decided 2022-04-13
Clearance details
- K-number
- K220556
- Device name
- OpenSensorX Series
- Applicant
- Dentimax, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-02-28
- Decision date
- 2022-04-13
- Days to decision
- 44 days
- Clearance type
- Special
- Product code
- MUH
- Device class
- 2
- Regulation number
- 872.1800
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mesa, AZ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Dentimax
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.