Identity
- Trade Name
- LOCATOR R-Tx EUDAMEDFDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- LOCATOR R-TX ABUTMENT - STANDARD EUDAMEDLOCATOR R-Tx Abutment, Neodent CM Connection, 2 mm cuff FDA UDI
- Model / Reference
- 32301-02-AO EUDAMEDFDA UDI
- Description
- LOCATOR R-Tx Abutment, Neodent CM Connection, 2 mm cuff FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840481129452 EUDAMEDFDA UDI
- Basic UDI-DI
- 08404811Z039EW EUDAMED
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Length — 2 Millimeter FDA UDI
Category: Dental implant suprastructure, permanent, preformed
LOCATOR R-Tx by Zest Anchors, LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
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- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Zest Anchors, LLC
Sources (2)
- FDA UDI e2de3d77-6e6d-40b7-9257-69ee1dc9237f 35 fields · synced Oct 7, 2026
- EUDAMED 130aafb1-b2fa-47ab-9e3e-20cd77bed22d 61 fields · synced Oct 7, 2026