FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMM DENTAL IRRIGATION TUBING SET
K Number: K090727
·
Decision Aug 13, 2009
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
60
Applicant Total
3
Review Days
147
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
- IMM DENTAL IRRIGATION TUBING SET
- K Number
- K090727
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innovative Medical Manufacturing Co.
- Date Received
- March 19, 2009
- Decision Date
- August 13, 2009
- 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