Identity
- Trade Name
- LOCATOR R-Tx EUDAMEDFDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- LOCATOR R-TX ABUTMENT ALL IN 1 EUDAMEDLOCATOR R-Tx Abument for Narrow Platform (NP) Internal Tri-Channel Connection Implant, Nobel Biocare, 2mm Cuff FDA UDI
- Model / Reference
- 30506-02 EUDAMEDFDA UDI
- Description
- LOCATOR R-Tx Abument for Narrow Platform (NP) Internal Tri-Channel Connection Implant, Nobel Biocare, 2mm Cuff FDA UDI
Identifiers
- Catalog Number
- 30506-02 FDA UDI
- Primary DI / UDI-DI
- 00840481112645 EUDAMEDFDA UDI
- Basic UDI-DI
- 08404811Z025EK 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
No
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
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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 0c12a1f1-5d43-44bd-baca-c44442f5ebd4 36 fields · synced Oct 7, 2026
- EUDAMED 7125e0fa-cd42-40eb-8c4d-7d7bb4695a75 61 fields · synced Oct 7, 2026