FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JETSONIC 2000
K Number: K990545
·
Decision Aug 11, 1999
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
47
Applicant Total
21
Review Days
170
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
- JETSONIC 2000
- K Number
- K990545
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6080
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sds Dental, Inc.
- Date Received
- February 22, 1999
- Decision Date
- August 11, 1999
- 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
RONDOFLEX PLUS 360
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
Other Clearances by Sds Dental, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K990546 | DELSONIC 2000 | Nov 5, 1999 | Substantially Equivalent |
| K964619 | DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL) | Jan 22, 1997 | Substantially Equivalent |
| K902864 | SURGICAL LIGHTING-CENTRA 450 | Sep 10, 1990 | Substantially Equivalent |
| K902865 | BAUMER SURGICAL TABLE | Sep 10, 1990 | Substantially Equivalent |
| K863011 | DENTATUS LS/EUROFLEX F-IV/ISOLIGHT REFLECT/CM-II | Oct 10, 1986 | Substantially Equivalent |
| K863021 | CM-II, CM-I WATER UNIT | Oct 1, 1986 | Substantially Equivalent |
| K863016 | DENTATUS L SET | Oct 1, 1986 | Substantially Equivalent |
| K863007 | EUROFLEX F-IV, ISOFLEX III | Oct 1, 1986 | Substantially Equivalent |
| K863015 | ISOPRAT C-III SET/ISOCART III AUXILIARY UNIT | Oct 1, 1986 | Substantially Equivalent |
| K863013 | ISOLAX PEDAL SET | Oct 1, 1986 | Substantially Equivalent |