Identity
- Trade Name
- Medidenta FDA UDI
- Generic Name
- Endodontic apex locator FDA UDI
- Device Name
- Apex locator, endodontic FDA UDI
- Model / Reference
- COMPEX FDA UDI
- Description
- Apex locator, endodontic FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944843605579 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
No
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: Endodontic apex locator
Medidenta by Guilin Woodpecker Medical Instrument Co., Ltd. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endodontic apex locator.
- Brasseler USA — Peter Brasseler Holdings, LLC · U
- PATTERSON — PATTERSON DENTAL SUPPLY, INC. · U
- EndoPilot Komet — Schlumbohm GmbH & Co. KG · U
- Henry Schein — HENRY SCHEIN, INC. · U
- EndoPilot Cap for lip-contact — Schlumbohm GmbH & Co. KG · U
- Brasseler USA — Peter Brasseler Holdings, LLC · U
- OSADA ENDEX PLUS — OSADA ELECTRIC CO., LTD. · U
- Apex Connect — META SYSTEMS CO., LTD. · 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.
- 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.
- 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
- Guilin Woodpecker Medical Instrument Co., Ltd.
Sources (1)
- FDA UDI 87656a24-89e7-4c9d-8fe1-7e97804114b1 34 fields · synced May 30, 2026