FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
MINIBLASTER
K Number: K013969
·
Decision Jan 10, 2002
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
47
Applicant Total
6
Review Days
38
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Basic Information
- Device Name
- MINIBLASTER
- K Number
- K013969
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6080
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Deldent , Ltd.
- Date Received
- December 3, 2001
- Decision Date
- January 10, 2002
- 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 |
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Other Clearances by Deldent , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K014249 | JETPOLISHER | Feb 19, 2002 | Substantially Equivalent |
| K014252 | JETSTREAM | Feb 19, 2002 | Substantially Equivalent |
| K014245 | JETSONIC 2000 | Jan 29, 2002 | Substantially Equivalent |
| K014238 | DELSONIC 2000 | Jan 24, 2002 | Substantially Equivalent |
| K011179 | DELDENT ULTRASONIC INSERTS | Jun 5, 2001 | Substantially Equivalent |