ORTHODONTIC ARCH
FDA 510(k) clearance K872622 · decided 1987-10-09
Clearance details
- K-number
- K872622
- Device name
- ORTHODONTIC ARCH
- Applicant
- Wonder Wire
- Decision
- Substantially Equivalent
- Date received
- 1987-07-06
- Decision date
- 1987-10-09
- Days to decision
- 95 days
- Clearance type
- Traditional
- Product code
- EJZ
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Wyomissing, PA, 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 |
|---|---|---|
| DENTAL INSTRUMENTS - KNIVES (K823315) | Miltex, Inc. | 1982-11-24 |
Recalls involving this device
No recalls on record reference this clearance.