DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE
FDA 510(k) clearance K122065 · decided 2013-02-08
Clearance details
- K-number
- K122065
- Device name
- DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE
- Applicant
- Ormco Corp.
- Decision
- Substantially Equivalent
- Date received
- 2012-07-13
- Decision date
- 2013-02-08
- Days to decision
- 210 days
- Clearance type
- Traditional
- Product code
- NOF
- Device class
- 2
- Regulation number
- 872.3661
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Orange, CA, 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 |
|---|---|---|
| LYTHOS DIGITAL IMPRESSION SYSTEM (K141611) | Ormco Corp. | 2014-12-05 |
| 3M TRUE DEFINITION SCANNER (K122467) | 3M Company | 2012-11-20 |
| 3M UNITEK LAVA CHAIRSIDE ORAL SCANNER (K081961) | Brontes Technologies | 2008-09-05 |
| 3M ESPE LAVA CHAIRSIDE ORAL SCANNER (K073199) | Brontes Technologies | 2007-12-21 |
Recalls involving this device
No recalls on record reference this clearance.