FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE FUGO BLADE FOR DENTISTRY
K Number: K063468
·
Decision Apr 18, 2007
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
18
Applicant Total
4
Review Days
153
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- THE FUGO BLADE FOR DENTISTRY
- K Number
- K063468
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4920
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medisurg , Ltd.
- Date Received
- November 16, 2006
- Decision Date
- April 18, 2007
- Product Code
- EKZ
- 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 |
|---|---|---|---|
| EKZ | Unit, Electrosurgical, And Accessories, Dental | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EKZ), ordered by most recent decision date.
Root ZX3
FDA 510(k)
FDA Class 2
·Dental
PERFECT TISSUE CONTOURING SYSTEM II
FDA 510(k)
FDA Class 2
·Dental
MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT
FDA 510(k)
FDA Class 2
·Dental
MC6A
FDA 510(k)
FDA Class 2
·Dental
X O ODONTOSURGE 4
FDA 510(k)
FDA Class 2
·Dental
BONART ART-E1 ELECTROSURGERY UNIT
FDA 510(k)
FDA Class 2
·Dental