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LOCATOR R-Tx
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 09260-2Ref 08820Ref 07305Ref 02704Ref 01484Ref 08317
Identity
- Trade Name
- LOCATOR EUDAMEDFDA UDILOCATOR R-Tx FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDIDental impression spacer FDA UDISurgical screwdriver, reusable FDA UDIFluted surgical drill bit, reusable FDA UDI
- Device Name
- LOCATOR Scan Body EUDAMEDLOCATOR ABUTMENT - STANDARD EUDAMEDLOCATOR DRILL/TAP EUDAMEDLOCATOR DRIVER EUDAMEDLOCATOR R-Tx Attachment System, 3.5/4.1 IC Implants, Avinent, 0.5mm Cuff FDA UDISCAN BODY, LOCATOR (2 PACK) FDA UDILOCATOR Abutment Driver Assembly for Sybron FDA UDILOCATOR Abutment for 3.3 BioSAF in s.r.l. x 4.0mm FDA UDILOCATOR Abutment for 5.0 3I (Hexed) X 0.73mm FDA UDIDrill Extender FDA UDILOCATOR Abutmentfor 3.6 Perform SM, Prodent x 4.0mm FDA UDI
- Model / Reference
- 09260-2 EUDAMEDFDA UDI08317 EUDAMEDFDA UDI02704 EUDAMEDFDA UDI08820 EUDAMEDFDA UDI07305 EUDAMEDFDA UDI01484 EUDAMEDFDA UDI32500-00 FDA UDI
- Description
- LOCATOR R-Tx Attachment System, 3.5/4.1 IC Implants, Avinent, 0.5mm Cuff FDA UDISCAN BODY, LOCATOR (2 PACK) FDA UDILOCATOR Abutment Driver Assembly for Sybron FDA UDILOCATOR Abutment for 3.3 BioSAF in s.r.l. x 4.0mm FDA UDILOCATOR Abutment for 5.0 3I (Hexed) X 0.73mm FDA UDIDrill Extender FDA UDILOCATOR Abutmentfor 3.6 Perform SM, Prodent x 4.0mm FDA UDI
Identifiers
- Catalog Number
- 02704 FDA UDI08820 FDA UDI01484 FDA UDI
- Primary DI / UDI-DI
- 00840481127427 EUDAMEDFDA UDI00840481106491 EUDAMEDFDA UDI00840481119705 EUDAMEDFDA UDI00840481105593 EUDAMEDFDA UDI00840481132698 EUDAMEDFDA UDI00840481103766 EUDAMEDFDA UDI00840481125904 FDA UDI
- Basic UDI-DI
- 08404811Z048EX EUDAMED08404811Z005ED EUDAMED08404811Z016EJ EUDAMED08404811Z017EL EUDAMED
- FDA Product Code
- NHA FDA UDINDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMEDL159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDIDental impression spacer FDA UDISurgical screwdriver, reusable FDA UDIFluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass IIb EUDAMEDClass IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI872.3980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDIFDA UDI
Implantable
Yes
EUDAMEDFDA UDIEUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 UDIFDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDIFDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 0.5 Millimeter FDA UDILength — 4 Millimeter FDA UDILength — 0.73 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.
- SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
- HS/HG Prosthetic System — OSSTEM IMPLANT Co., Ltd. · Class II
- DESS dental smart solutions — TERRATS MEDICAL SL. · Class II
- Diamodent — Diamodent · Class II
- Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 (13)
- FDA UDI 6c616d64-6dcf-4eb8-9cb7-567c5f0907ca 35 fields · synced Sep 30, 2026
- FDA UDI 38c311c2-663c-4b70-a780-6a87f7311802 34 fields · synced May 27, 2026
- FDA UDI 491e33e1-54b6-4656-af1d-3542fedac095 34 fields · synced May 29, 2026
- FDA UDI cc54d3ce-1f9c-4649-a860-cda70fd60708 36 fields · synced May 30, 2026
- FDA UDI d36d197a-b7e5-4537-a654-9cb3bafa2db0 36 fields · synced May 30, 2026
- FDA UDI 869d4477-416f-4586-aaed-59fa0c7818b6 34 fields · synced May 30, 2026
- FDA UDI 9085bea5-d71f-4475-a0ae-7bda1f7f5356 36 fields · synced May 30, 2026
- EUDAMED 8bcff78f-bf77-44c5-82a5-6a7681204cc2 61 fields · synced Jul 14, 2026
- EUDAMED 307b328b-863c-4067-a694-fec316fe1000 61 fields · synced Sep 17, 2026
- EUDAMED fc56348c-7238-48d8-b1b4-8155b4bca1fd 61 fields · synced Sep 17, 2026
- EUDAMED a83ee167-3406-4cd0-8f07-dc04d29ffbd1 61 fields · synced Sep 30, 2026
- EUDAMED 9ca7db2e-6a5e-4d8c-9940-61ab0adc6e17 61 fields · synced Sep 30, 2026
- EUDAMED 08721cc6-e9ce-4304-9b57-a32f67cfe842 61 fields · synced Sep 30, 2026