LOCATOR Overdenture Implant System
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- LOCATOR Overdenture Implant System EUDAMEDFDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- LODI All-IN ONE PACK - STANDARD EUDAMEDLOCATOR Overdenture Implant, 3.9mmD x 8mmL, 5mm Cuff FDA UDILOCATOR Overdenture Implant, 3.9mmD x 8mmL, 2.5mm Cuff FDA UDILOCATOR Overdenture Implant, 3.9mmD x 10mmL, 4mm Cuff FDA UDI
- Model / Reference
- 07505-02 EUDAMEDFDA UDI07506-04 EUDAMEDFDA UDI07505-05 FDA UDI
- Description
- LOCATOR Overdenture Implant, 3.9mmD x 8mmL, 5mm Cuff FDA UDILOCATOR Overdenture Implant, 3.9mmD x 8mmL, 2.5mm Cuff FDA UDILOCATOR Overdenture Implant, 3.9mmD x 10mmL, 4mm Cuff FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840481130960 EUDAMEDFDA UDI00840481131035 EUDAMEDFDA UDI00840481130991 FDA UDI
- Basic UDI-DI
- 08404811Z066EZ EUDAMED
- FDA Product Code
- DZE FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Length — 5 Millimeter FDA UDILength — 2.5 Millimeter FDA UDILength — 4 Millimeter FDA UDI
Category: Screw endosteal dental implant, two-piece
LOCATOR Overdenture Implant System 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 (5)
- FDA UDI 9a1aa520-b7ee-4e2b-bc08-334893a63fb5 35 fields · synced Sep 30, 2026
- FDA UDI 95c970a7-f366-4d2d-8f09-577bd85a770a 35 fields · synced May 27, 2026
- FDA UDI 7a075ced-18a2-4ab3-8b5b-1502cde92358 35 fields · synced May 30, 2026
- EUDAMED 37698c4d-93b2-4897-b4b9-7d1c257b0664 61 fields · synced Aug 1, 2026
- EUDAMED 4a83e3b2-3aae-413b-bfa5-641bbaca3e8b 61 fields · synced Sep 30, 2026