FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROTEK MINI-MAX DRILL SYSTEM
K Number: K874535
·
Decision Nov 23, 1987
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
48
Applicant Total
24
Review Days
20
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
- MICROTEK MINI-MAX DRILL SYSTEM
- K Number
- K874535
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4120
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Microtek Medical, Inc.
- Date Received
- November 3, 1987
- Decision Date
- November 23, 1987
- Product Code
- DZI
- 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 |
|---|---|---|---|
| DZI | Drill, Bone, Powered | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DZI), ordered by most recent decision date.
Implantmed Plus II & Piezomed Plus II Module
FDA 510(k)
FDA Class 2
·Dental
VarioSurg 4
FDA 510(k)
FDA Class 2
·Dental
MT-Bone
FDA 510(k)
FDA Class 2
·Dental
Surgical Drive System (Model: ES70, ES90, E8)
FDA 510(k)
FDA Class 2
·Dental
Guided Surgery Kit
FDA 510(k)
FDA Class 2
·Dental
TRAUS SUS20
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Microtek Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K110358 | VENODYNE V810 | May 5, 2011 | Substantially Equivalent |
| K102971 | FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK | Feb 23, 2011 | Substantially Equivalent |
| K062899 | MICROTEK MEDICAL SURGICAL GOWN/TOGA | Jan 25, 2007 | Substantially Equivalent |
| K060200 | MICROTEK MEDICAL WARMING DRAPE | May 31, 2006 | Substantially Equivalent |
| K050322 | MICROTEK EQUIPMENT DRAPES | May 17, 2005 | Substantially Equivalent |
| K022903 | CHILLBUSTER | Nov 27, 2002 | Substantially Equivalent |
| K020956 | VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA | May 16, 2002 | Substantially Equivalent |
| K011318 | VENODYNE DVT ADVANTAGE PLUS | Oct 25, 2001 | Substantially Equivalent |
| K001802 | VENODYNE DVT ADVANTAGE MODEL 610 | Jan 9, 2001 | Substantially Equivalent |
| K950906 | LESINSKI SURGICAL EAR DRESSING | Jun 22, 1995 | Substantially Equivalent |