FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PIEZOTOME
K Number: K060274
·
Decision May 1, 2006
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
48
Applicant Total
24
Review Days
88
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
- PIEZOTOME
- K Number
- K060274
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4120
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Satelec
- Date Received
- February 2, 2006
- Decision Date
- May 1, 2006
- 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 Satelec
| K Number | Device Name | ||
|---|---|---|---|
| K110379 | AIR-N-GO | Dec 8, 2011 | Substantially Equivalent |
| K100410 | PIEZOELECTRIC SYSTEM | Apr 28, 2010 | Substantially Equivalent |
| K091331 | PIEZOTOME 2 | Dec 11, 2009 | Substantially Equivalent |
| K091252 | IMPLANT CENTER 2 | Jul 22, 2009 | Substantially Equivalent |
| K082116 | HEMOSTASYL PASTE | Dec 17, 2008 | Substantially Equivalent |
| K072181 | MINI LED AUTOFOCUS | Sep 19, 2007 | Substantially Equivalent |
| K071965 | I-SURGE | Sep 10, 2007 | Substantially Equivalent |
| K060275 | PIEZOTOME | May 3, 2006 | Substantially Equivalent |
| K053328 | BIOSPLINT SPLINTING RIBBON | Jan 25, 2006 | Substantially Equivalent |
| K050895 | SURPASSON P5 NEWTRON | Apr 20, 2005 | Substantially Equivalent |