Identity
- Trade Name
- StarDental Instrument Solutions FDA UDI
- Generic Name
- Dental surgical power tool motorized handpiece/set, pneumatic FDA UDI
- Device Name
- MOTOR, 5K (ESA ATTACHMENT) FDA UDI
- Model / Reference
- 265208 FDA UDI
- Description
- MOTOR, 5K (ESA ATTACHMENT) FDA UDI
Identifiers
- Primary DI / UDI-DI
- D7022652080 FDA UDI
- FDA Product Code
- EGS 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental surgical power tool motorized handpiece/set, pneumatic
StarDental Instrument Solutions by Dentalez, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental surgical power tool motorized handpiece/set, pneumatic.
- Midwest 45 FBE NFO — J.MORITA MFG.CORP. · Class I
- Lares Research — Lares Research, Inc. · Class I
- Air-Driven Dental Handpieces — MDK CO., LTD. · Class I
- Vector R&D, Inc — Vector R&D, Inc. · Class I
- ARETE — J.MORITA MFG.CORP. · Class I
- M900 — NAKANISHI INC. · Class I
- iPA-HP — NAKANISHI INC. · Class I
- TK-98 LM Synea Vision — W & H Dentalwerk Bürmoos GmbH · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dentalez, Inc.
Sources (1)
- FDA UDI ff8bc9e3-7141-40e1-ac0f-acde86a78a68 34 fields · synced Jun 1, 2026