FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NITINOL, NITI
K Number: K935638
·
Decision May 18, 1994
Classifications
1
FEI Numbers
168
Registration Numbers
168
Same Product Code
29
Applicant Total
7
Review Days
176
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Basic Information
- Device Name
- NITINOL, NITI
- K Number
- K935638
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.5410
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Highland Metals
- Date Received
- November 23, 1993
- Decision Date
- May 18, 1994
- Product Code
- DZC
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DZC | Wire, Orthodontic | FDA class 1 | Dental |
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Other Clearances by Highland Metals
| K Number | Device Name | ||
|---|---|---|---|
| K933374 | NITI COIL SPRINGS | Nov 19, 1993 | Substantially Equivalent |
| K933377 | STAINLESS STEEL ARCHES REPACKER RELABETER | Nov 16, 1993 | Substantially Equivalent |
| K933380 | REVERSE SURVE NITI ARCH WIRE | Nov 12, 1993 | Substantially Equivalent |
| K933378 | REVERSE CURVE NITI ARCH WIRE REPACKER RELABETER | Nov 12, 1993 | Substantially Equivalent |
| K933376 | NITI ARCH WIRE ON A SPOOL | Nov 12, 1993 | Substantially Equivalent |
| K933379 | STAINLESS STEEL ARCHES | Nov 12, 1993 | Substantially Equivalent |