Identity
- Trade Name
- VarioSurg FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system handpiece tip, endodontic FDA UDI
- Model / Reference
- E30LD-S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560264562899 FDA UDI
- 510(k) Number
- K073678 FDA UDI
- FDA Product Code
- DZI FDA UDIELC FDA UDI
- GMDN Term
- Ultrasonic dental scaling/debridement system handpiece tip, endodontic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4120 FDA UDI872.4850 FDA UDI
- 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
Moist Heat or Steam Sterilization FDA UDI
Category: Ultrasonic dental scaling/debridement system handpiece tip, endodontic
VarioSurg by Nakanishi Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ultrasonic dental scaling/debridement system handpiece tip, endodontic.
- DTE — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
- WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
- Brasseler USA — Peter Brasseler Holdings, LLC · Class II
- WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
- Obtura Spartan — OBTURA SPARTAN ENDODONTICS · Class II
- WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
- MECTRON — MECTRON SPA · Class II
- WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
Cleared under the same submission
K073678 also covers:
- Basic-S Kit — NAKANISHI INC.
- Bone Cut Kit — NAKANISHI INC.
- Endo-S Kit — NAKANISHI INC.
- Implant Preparation Kit — NAKANISHI INC.
- Sinus Lift Kit — NAKANISHI INC.
- VarioSurg — NAKANISHI INC.
- VarioSurg — NAKANISHI INC.
- VarioSurg — NAKANISHI INC.
- VarioSurg — NAKANISHI INC.
- VarioSurg — NAKANISHI INC.
- VarioSurg — NAKANISHI INC.
- VarioSurg — NAKANISHI INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nakanishi Inc.
Sources (1)
- FDA UDI bcd29e75-924d-42fb-bbb6-99eac7d1328f 33 fields · synced May 30, 2026