Identity
- Trade Name
- SQUARE BROACH FDA UDI
- Generic Name
- Endodontic broach, smooth FDA UDI
- Device Name
- Endodontic instruments for professionnal use only FDA UDI
- Model / Reference
- n10 L29 FDA UDI
- Description
- Endodontic instruments for professionnal use only FDA UDI
Identifiers
- Catalog Number
- 20115008 FDA UDI
- Primary DI / UDI-DI
- J015201150081 FDA UDI
- FDA Product Code
- EKB FDA UDI
- GMDN Term
- Endodontic broach, smooth 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
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: Endodontic broach, smooth
Square Broach by Micro Mega — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endodontic broach, smooth.
- SMOOTH BROACH — MICRO MEGA · Class I
- SQUARE BROACH — MICRO MEGA · Class I
- SMOOTH BROACH — MICRO MEGA · Class I
- SQUARE BROACH — MICRO MEGA · 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 25541963-4718-432a-9c25-11213b354a5c 34 fields · synced May 30, 2026