Identity
- Trade Name
- EdgeOne-R Utopia FDA UDI
- Generic Name
- Rotary/reciprocating endodontic file/rasp, single-use FDA UDI
- Device Name
- Endodontic instrument for professional dental use only FDA UDI
- Model / Reference
- Asst v2 L21 Sterile FDA UDI
- Description
- Endodontic instrument for professional dental use only FDA UDI
Identifiers
- Catalog Number
- EORUA21Sv2 FDA UDI
- Primary DI / UDI-DI
- 03701310322765 FDA UDI
- FDA Product Code
- EKS FDA UDI
- GMDN Term
- Rotary/reciprocating endodontic file/rasp, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Rotary/reciprocating endodontic file/rasp, single-use
EdgeOne-R Utopia by Micro Mega — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rotary/reciprocating endodontic file/rasp, single-use.
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
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- EdgeTaper Encore Platinum — US Endodontics, LLC · Class I
- Peeso Reamers — TULSA DENTAL PRODUCTS LLC · Class I
- MiniKut — Dental Engineering Laboratories, LLC · Class I
- VaryFlex Reciprocating, VFRF 50, 25mm — ENDOPERFECTION LIMITED · Class I
- EDGEONE BLAZE UTOPIA — US Endodontics, LLC · 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 |
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Manufacturer
- Manufacturer
- Micro Mega
Sources (1)
- FDA UDI 86ed8b2f-8b3f-41a1-a9b6-2f340ec6dbfc 35 fields · synced Jun 1, 2026