FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
COMFORTRON DENTAL ANESTHESIA APPARATUS
K Number: K884586
·
Decision Apr 14, 1989
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
14
Applicant Total
3
Review Days
163
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
- COMFORTRON DENTAL ANESTHESIA APPARATUS
- K Number
- K884586
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- M. D. Products
- Date Received
- November 2, 1988
- Decision Date
- April 14, 1989
- Product Code
- LWM
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LWM | Device, Electrical Dental Anesthesia | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LWM), ordered by most recent decision date.
Dental Pain Eraser
FDA 510(k)
FDA Unclassified
·Unknown
Dental Pain Eraser
FDA 510(k)
FDA Unclassified
·Unknown
Dental Pain Eraser
FDA 510(k)
FDA Unclassified
·Unknown
TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670
FDA 510(k)
FDA Unclassified
·Unknown
3M DENTAL ELECTRONONIC ANESTHESIA (DEA0 SYSTEM 8670 ADDITIONAL APPLICATIONS
FDA 510(k)
FDA Unclassified
·Unknown