FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRASONIC TOOTH SCALER MODEL DSCIOP
K Number: K852540
·
Decision Jul 1, 1985
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
194
Applicant Total
53
Review Days
17
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
- ULTRASONIC TOOTH SCALER MODEL DSCIOP
- K Number
- K852540
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4850
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Parkell, Inc.
- Date Received
- June 14, 1985
- Decision Date
- July 1, 1985
- 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 Parkell, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243254 | Parkell Pit and Fissure Sealant | Aug 8, 2025 | Substantially Equivalent |
| K210259 | Parkell Self-Adhesive Cement | Jan 20, 2022 | Substantially Equivalent |
| K191103 | Parkell Desensitizer Gel | Nov 22, 2019 | Substantially Equivalent |
| K190930 | SmarTemp X1 | Sep 5, 2019 | Substantially Equivalent |
| K182296 | HyperFil-LV | Dec 14, 2018 | Substantially Equivalent |
| K172176 | Parkell Universal Adhesive | Nov 21, 2017 | Substantially Equivalent |
| K151518 | BRUSH&BOND PLUS | Sep 18, 2015 | Substantially Equivalent |
| K142848 | EAZY PRIMER | Feb 24, 2015 | Substantially Equivalent |
| K132115 | ABSOLUTE DENTIN 2 | Jun 25, 2014 | Substantially Equivalent |
| K113839 | RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE | Apr 12, 2012 | Substantially Equivalent |