FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AMD DENTIST AND HYGIENIST KITS
K Number: K925115
·
Decision Jul 5, 1994
Classifications
1
FEI Numbers
99
Registration Numbers
99
Same Product Code
71
Applicant Total
32
Review Days
634
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Basic Information
- Device Name
- AMD DENTIST AND HYGIENIST KITS
- K Number
- K925115
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advance Medical Designs, Inc.
- Date Received
- October 9, 1992
- Decision Date
- July 5, 1994
- Product Code
- EKJ
- 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 |
|---|---|---|---|
| EKJ | Burnisher, Operative | FDA class 1 | Dental |
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