FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
1ST IMPRESSION
K Number: K921571
·
Decision Sep 10, 1993
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
3
Review Days
526
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Basic Information
- Device Name
- 1ST IMPRESSION
- K Number
- K921571
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wykle Research, Inc.
- Date Received
- April 2, 1992
- Decision Date
- September 10, 1993
- Product Code
- ELW
- 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 |
|---|---|---|---|
| ELW | Material, Impression | FDA class 2 | Dental |
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