BAND SEATER
FDA 510(k) clearance K951776 · decided 1995-05-23
Clearance details
- K-number
- K951776
- Device name
- BAND SEATER
- Applicant
- Ormco Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-04-13
- Decision date
- 1995-05-23
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- ECR
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Glendora, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ormco Corp.
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.
| Record | Firm | Date |
|---|---|---|
| DENTAURUM BAND SEATER AND BAND SEATING INSTRUMENTS (K935156) | Dentauraum, Inc. | 1994-02-03 |
| FLEXI-POST (K843018) | Essential Dental Systems, Inc. | 1984-09-27 |
Recalls involving this device
No recalls on record reference this clearance.