ORTHODONTIC NITINOL SPRINGS
FDA 510(k) clearance K881331 · decided 1988-04-21
Clearance details
- K-number
- K881331
- Device name
- ORTHODONTIC NITINOL SPRINGS
- Applicant
- Flexmedics
- Decision
- Substantially Equivalent
- Date received
- 1988-03-29
- Decision date
- 1988-04-21
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- EJW
- Device class
- 1
- Regulation number
- 872.3285
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Minneapolis, MN, 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 |
|---|---|---|
| WIRONTOM CLASP WIRE (K901257) | Ivoclar North America, Inc. | 1990-04-25 |
| VITALLIUM WIRE (K872746) | Austenal Dental, Inc. | 1987-07-21 |
Recalls involving this device
No recalls on record reference this clearance.