FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
E3 TORQUE CONTROL MOTOR
K Number: K103653
·
Decision May 26, 2011
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
60
Applicant Total
36
Review Days
164
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
- E3 TORQUE CONTROL MOTOR
- K Number
- K103653
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentsply International, Inc.
- Date Received
- December 13, 2010
- Decision Date
- May 26, 2011
- Product Code
- EBW
- 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 |
|---|---|---|---|
| EBW | Controller, Foot, Handpiece And Cord | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBW), ordered by most recent decision date.
Motor Handpiece and Control Unit (SDI10)
FDA 510(k)
FDA Class 1
·Dental
Star E900 Electric System
FDA 510(k)
FDA Class 1
·Dental
Motor and Apex Module (MaAM)
FDA 510(k)
FDA Class 1
·Dental
ELEC ENGINE (Model: ISE-170L)
FDA 510(k)
FDA Class 1
·Dental
Dental Implant Unit
FDA 510(k)
FDA Class 1
·Dental
NLZ Built-In Motor System
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Dentsply International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K160207 | ATLANTIS ISUS Implant Suprastructures | Sep 21, 2016 | Substantially Equivalent |
| K160232 | Disposable Barrier Sleeves and Covers | Jun 7, 2016 | Substantially Equivalent |
| K151439 | ATLANTIS ISUS | Feb 19, 2016 | Substantially Equivalent |
| K152247 | ATLANTIS Crown | Jan 29, 2016 | Substantially Equivalent |
| K151039 | ATLANTIS Abutment for NobelActive 3.0 | Jan 14, 2016 | Substantially Equivalent |
| K151619 | Prime&Bond Elect Universal Dental Adhesive | Oct 30, 2015 | Substantially Equivalent |
| K150535 | Cavitron Touch Ultrasonic Scaling System | Jun 16, 2015 | Substantially Equivalent |
| K142178 | PROROOT MTA WHITE, PROROOT MTA GRAY | Feb 26, 2015 | Substantially Equivalent |
| K131907 | RAYPEX 6 | Jan 31, 2014 | Substantially Equivalent |
| K131644 | ANKYLOS SYNCONE ABUTMENT 5(DEGREE) | Jan 22, 2014 | Substantially Equivalent |