FLEXI-POST
FDA 510(k) clearance K843018 · decided 1984-09-27
Clearance details
- K-number
- K843018
- Device name
- FLEXI-POST
- Applicant
- Essential Dental Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-08-01
- Decision date
- 1984-09-27
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- ECR
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Walker, MI, 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 |
|---|---|---|
| BAND SEATER (K951776) | Ormco Corp. | 1995-05-23 |
| DENTAURUM BAND SEATER AND BAND SEATING INSTRUMENTS (K935156) | Dentauraum, Inc. | 1994-02-03 |
Recalls involving this device
No recalls on record reference this clearance.