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Variosurg

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K073678

by Nakanishi Inc.

Identity

Trade Name
VarioSurg FDA UDI
Generic Name
Dental ultrasonic surgical system handpiece tip FDA UDI
Model / Reference
SG16A FDA UDI

Identifiers

Primary DI / UDI-DI
04560264563087 FDA UDI
510(k) Number
K073678 FDA 510(k)FDA UDI
FDA Product Code
DZI FDA 510(k)FDA UDI
ELC FDA UDI
GMDN Term
Dental ultrasonic surgical system handpiece tip FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 872.4120 FDA 510(k)
Regulation Number
872.4120 FDA 510(k)FDA UDI
872.4850 FDA UDI
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Variosurg by Nakanishi Inc. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nakanishi Inc.
FDA Applicant
Nakanishi, Inc.

Sources (2)

  • FDA 510(k) K073678 24 fields · synced Jun 18, 2026
  • FDA UDI f5b6d899-caf2-49b3-93c3-9b4f7c836bf1 33 fields · synced May 27, 2026