FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ORTHODONTIC ARCH WIRE
K Number: K924805
·
Decision Mar 31, 1993
Classifications
1
FEI Numbers
168
Registration Numbers
168
Same Product Code
29
Applicant Total
6
Review Days
188
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Basic Information
- Device Name
- ORTHODONTIC ARCH WIRE
- K Number
- K924805
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.5410
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ultimate Wireforms, Inc.
- Date Received
- September 24, 1992
- Decision Date
- March 31, 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 Ultimate Wireforms, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K960799 | ORTHO-ICE | May 9, 1996 | Substantially Equivalent |
| K923837 | DIMPLED MULTI MODULUS ARCH WIRE | Mar 31, 1993 | Substantially Equivalent |
| K923836 | .016' X .016 NICKEL TITANIUM UPRIGHTING SPRING | Dec 23, 1992 | Substantially Equivalent |
| K923838 | THE ULTIMATE RCS ARCH WIRE | Dec 4, 1992 | Substantially Equivalent |
| K923839 | NITINOL GENTLE TOUCH COIL SPRING | Oct 15, 1992 | Substantially Equivalent |