FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MATRX DENTAL UNIT
K Number: K893219
·
Decision Aug 7, 1989
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
283
Applicant Total
14
Review Days
102
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
- MATRX DENTAL UNIT
- K Number
- K893219
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Matrix Medica, Inc.
- Date Received
- April 27, 1989
- Decision Date
- August 7, 1989
- Product Code
- EIA
- 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 |
|---|---|---|---|
| EIA | Unit, Operative Dental | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EIA), ordered by most recent decision date.
Midmark Dental Delivery System
FDA 510(k)
FDA Class 1
·Dental
K5 Cart, K5 Mount, K5 Swing
FDA 510(k)
FDA Class 1
·Dental
Integral Dental Unit
FDA 510(k)
FDA Class 1
·Dental
Integral Dental Units
FDA 510(k)
FDA Class 1
·Dental
Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus
FDA 510(k)
FDA Class 1
·Dental
BDC Dental Unit
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Matrix Medica, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K961536 | FLEXSCOPE | Sep 18, 1996 | Substantially Equivalent |
| K923693 | KLORMAN | Jan 23, 1996 | Substantially Equivalent |
| K921982 | MATRX HOPE(R) 5 RESUSCITATOR | Oct 28, 1994 | Substantially Equivalent |
| K915353 | MATRX MEDICAL MAXIMIZER 1000 AND 2000 VACUUM PUMP | Dec 27, 1991 | Substantially Equivalent |
| K912661 | MATRX, PYRAMID TRIANGLE BANDAGE | Aug 21, 1991 | Substantially Equivalent |
| K900551 | MATRX DISPOSABLE NON-INVASIVE GELLED PACING ELEC. | May 9, 1990 | Substantially Equivalent |
| K895533 | LIFE DEFENSE PLUS(TM), DEFIBRILLATOR/MONITOR/PACER | Jan 26, 1990 | Substantially Equivalent |
| K895525 | MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER | Jan 26, 1990 | Substantially Equivalent |
| K883833 | NITRONOX(R), FIRST RESPONSE NITRONOX(TM) | Feb 17, 1989 | Substantially Equivalent |
| K884879 | CENTURION(TM) MIXER | Feb 9, 1989 | Substantially Equivalent |