Identity
- Trade Name
- EDGE ENDO FDA UDI
- Generic Name
- Endodontic apex locator FDA UDI
- Device Name
- EdgeApex Tester FDA UDI
- Model / Reference
- EEALUT FDA UDI
- Description
- EdgeApex Tester FDA UDI
Identifiers
- Catalog Number
- EEALUT FDA UDI
- Primary DI / UDI-DI
- 00810988031350 FDA UDI
- 510(k) Number
- K181087 FDA UDI
- FDA Product Code
- LQY FDA UDI
- GMDN Term
- Endodontic apex locator FDA UDI
Classification
- Device Class
- U 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endodontic apex locator
Edge Endo by Handpiece Parts & Repairs, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endodontic apex locator.
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- Medidenta — Guilin Woodpecker Medical Instrument Co., Ltd. · U
- PATTERSON — PATTERSON DENTAL SUPPLY, INC. · U
- DTE — Guilin Woodpecker Medical Instrument Co., Ltd. · U
- EndoPilot Komet — Schlumbohm GmbH & Co. KG · U
- Henry Schein — HENRY SCHEIN, INC. · U
- EndoPilot Cap for lip-contact — Schlumbohm GmbH & Co. KG · U
Cleared under the same submission
K181087 also covers:
- Accurator — Beyes Dental Canada Inc
- Accurator — Beyes Dental Canada Inc
- Accurator — Beyes Dental Canada Inc
- Accurator — Beyes Dental Canada Inc
- ApexPilot — Beyes Dental Canada Inc
- ApexPilot — Beyes Dental Canada Inc
- DTE — Guilin Woodpecker Medical Instrument Co., Ltd.
- Medidenta — Guilin Woodpecker Medical Instrument Co., Ltd.
- WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd.
- WOODPECKER, DTE — Guilin Woodpecker Medical Instrument Co., Ltd.
- WOODPECKER, DTE — Guilin Woodpecker Medical Instrument Co., Ltd.
- WOODPECKER, DTE — Guilin Woodpecker Medical Instrument Co., Ltd.
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 U | Pending data |
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Manufacturer
- Manufacturer
- Handpiece Parts & Repairs, Inc.
Sources (1)
- FDA UDI 73ba4a2d-28ad-475b-8810-1c899e7ac59f 35 fields · synced May 30, 2026