WIRONTOM CLASP WIRE
FDA 510(k) clearance K901257 · decided 1990-04-25
Clearance details
- K-number
- K901257
- Device name
- WIRONTOM CLASP WIRE
- Applicant
- Ivoclar North America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-03-15
- Decision date
- 1990-04-25
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- EJW
- Device class
- 1
- Regulation number
- 872.3285
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Amherst, NY, 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 |
|---|---|---|
| ORTHODONTIC NITINOL SPRINGS (K881331) | Flexmedics | 1988-04-21 |
| VITALLIUM WIRE (K872746) | Austenal Dental, Inc. | 1987-07-21 |
Recalls involving this device
No recalls on record reference this clearance.