FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VIBRATORY ENDODONTIC SYSTEM
K Number: K832378
·
Decision Oct 4, 1983
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
1
Applicant Total
3
Review Days
77
Basic Information
- Device Name
- VIBRATORY ENDODONTIC SYSTEM
- K Number
- K832378
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- SYNTEX DENTAL PRODUCTS, INC.
- Date Received
- July 19, 1983
- Decision Date
- October 4, 1983
- Product Code
- EKQ
- 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 |
|---|---|---|---|
| EKQ | Preparer, Root Canal Endodontic | FDA class 1 | Dental |
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