FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VARIOSURG
K Number: K073678
·
Decision Jul 10, 2008
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
48
Applicant Total
40
Review Days
195
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
- VARIOSURG
- K Number
- K073678
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4120
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Nakanishi, Inc.
- Date Received
- December 28, 2007
- Decision Date
- July 10, 2008
- 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 Nakanishi, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260773 | Varios Combi Pro2 | Mar 10, 2026 | Substantially Equivalent |
| K254163 | VarioSurg 4 | Dec 23, 2025 | Substantially Equivalent |
| K251689 | VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) | Sep 19, 2025 | Substantially Equivalent |
| K252662 | UniBur | Sep 19, 2025 | Substantially Equivalent |
| K241880 | Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) | Sep 20, 2024 | Substantially Equivalent |
| K233288 | NLZ Built-In Motor System | Jun 24, 2024 | Substantially Equivalent |
| K233117 | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) | Jun 20, 2024 | Substantially Equivalent |
| K233308 | Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) | Apr 25, 2024 | Substantially Equivalent |
| K230888 | Titanium Turbine | Jun 2, 2023 | Substantially Equivalent |
| K230106 | General Cutting Straight | May 24, 2023 | Substantially Equivalent |