FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
DELDENT ULTRASONIC INSERTS
K Number: K011179
·
Decision Jun 5, 2001
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
194
Applicant Total
6
Review Days
49
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
- DELDENT ULTRASONIC INSERTS
- K Number
- K011179
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4850
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Deldent , Ltd.
- Date Received
- April 17, 2001
- Decision Date
- June 5, 2001
- Product Code
- ELC
- 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 |
|---|---|---|---|
| ELC | Scaler, Ultrasonic | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ELC), ordered by most recent decision date.
Varios Combi Pro2
FDA 510(k)
FDA Class 2
·Dental
GBT Machine Airflow Prophylaxis Master
FDA 510(k)
FDA Class 2
·Dental
VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)
FDA 510(k)
FDA Class 2
·Dental
Integrated Endo System (Meet Endo-II)
FDA 510(k)
FDA Class 2
·Dental
OdneClean
FDA 510(k)
FDA Class 2
·Dental
Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017)
FDA 510(k)
FDA Class 2
·Dental
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 |
| K013969 | MINIBLASTER | Jan 10, 2002 | Substantially Equivalent |