FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STAINLESS STEEL ARCHES REPACKER RELABETER
K Number: K933377
·
Decision Nov 16, 1993
Classifications
1
FEI Numbers
181
Registration Numbers
181
Same Product Code
29
Applicant Total
7
Review Days
130
Basic Information
- Device Name
- STAINLESS STEEL ARCHES REPACKER RELABETER
- K Number
- K933377
- 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
- July 9, 1993
- Decision Date
- November 16, 1993
- 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 | ||
|---|---|---|---|
| K935638 | NITINOL, NITI | May 18, 1994 | Substantially Equivalent |
| K933374 | NITI COIL SPRINGS | Nov 19, 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 |