FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OPALDAM
K Number: K971284
·
Decision Jun 3, 1997
Classifications
1
FEI Numbers
327
Registration Numbers
327
Same Product Code
7
Applicant Total
103
Review Days
57
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Basic Information
- Device Name
- OPALDAM
- K Number
- K971284
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ultradent Products, Inc.
- Date Received
- April 7, 1997
- Decision Date
- June 3, 1997
- Product Code
- EIG
- 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 |
|---|---|---|---|
| EIG | Retractor, All Types | FDA class 1 | Dental |
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