Identity
- Trade Name
- M800WL FDA UDI
- Generic Name
- Dental surgical power tool motorized handpiece/set, pneumatic FDA UDI
- Model / Reference
- M800WL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560264570429 FDA UDI
- 510(k) Number
- K203791 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Dental surgical power tool motorized handpiece/set, pneumatic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental surgical power tool motorized handpiece/set, pneumatic
M800wl by Nakanishi Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental surgical power tool motorized handpiece/set, pneumatic.
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Cleared under the same submission
K203791 also covers:
- DCI Edge — DCI International, LLC
- Cleaning Wire — NAKANISHI INC.
- FM-CL-M4 — NAKANISHI INC.
- FM-CL-M4-T — NAKANISHI INC.
- KCL Coupling Wrench — NAKANISHI INC.
- KCL-LED — NAKANISHI INC.
- M800 — NAKANISHI INC.
- M800KL — NAKANISHI INC.
- M800L — NAKANISHI INC.
- M900 — NAKANISHI INC.
- M900K — NAKANISHI INC.
- M900KL — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Nakanishi Inc.
Sources (1)
- FDA UDI da4479c1-c318-4415-a548-77c1d520fcf6 33 fields · synced May 30, 2026