FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185
K Number: K032607
·
Decision Nov 10, 2003
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
48
Applicant Total
93
Review Days
77
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
- POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185
- K Number
- K032607
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4120
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Linvatec Corp.
- Date Received
- August 25, 2003
- Decision Date
- November 10, 2003
- 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 Linvatec Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K092998 | CONMED LINVATEC INTERCEPT IMPLANT | Dec 23, 2009 | Substantially Equivalent |
| K091549 | CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM | Jun 23, 2009 | Substantially Equivalent |
| K090835 | CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR | Jun 22, 2009 | Substantially Equivalent |
| K090186 | CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES | Apr 10, 2009 | Substantially Equivalent |
| K083281 | EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA- | Feb 25, 2009 | Substantially Equivalent |
| K060198 | MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW | May 11, 2006 | Substantially Equivalent |
| K060260 | MICROPOWER HAND PIECE HIGH SPEED DRILL | Apr 10, 2006 | Substantially Equivalent |
| K060270 | MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL | Apr 10, 2006 | Substantially Equivalent |
| K050519 | ADVANCED TURBO DRIVE SYSTEM | May 17, 2005 | Substantially Equivalent |
| K050497 | BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET | Mar 25, 2005 | Substantially Equivalent |