FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DENTI-TRAY(TM)
K Number: K871493
·
Decision Jun 24, 1987
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
6
Applicant Total
3
Review Days
69
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Basic Information
- Device Name
- DENTI-TRAY(TM)
- K Number
- K871493
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Advanced Medical, Inc.
- Date Received
- April 16, 1987
- Decision Date
- June 24, 1987
- Product Code
- EKW
- 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 |
|---|---|---|---|
| EKW | Broach, Endodontic | FDA class 1 | Dental |
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