FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RONDOFLEX PLUS 360
K Number: K042872
·
Decision Nov 23, 2004
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
47
Applicant Total
4
Review Days
36
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
- RONDOFLEX PLUS 360
- K Number
- K042872
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.6080
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kavo America Corporation
- Date Received
- October 18, 2004
- Decision Date
- November 23, 2004
- Product Code
- KOJ
- 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 |
|---|---|---|---|
| KOJ | Airbrush | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KOJ), ordered by most recent decision date.
turbodent touch
FDA 510(k)
FDA Class 2
·Dental
BETA-POWDER
FDA 510(k)
FDA Class 2
·Dental
PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER
FDA 510(k)
FDA Class 2
·Dental
PREPAIR
FDA 510(k)
FDA Class 2
·Dental
VELOPEX AQUACUT FLUID ABRASION UNIT
FDA 510(k)
FDA Class 2
·Dental
GROMAN PREPMASTER
FDA 510(k)
FDA Class 2
·Dental