Identity
- Trade Name
- LOCATOR R-Tx FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Low Retention Insert, LOCATOR R-Tx Attachment System FDA UDI
- Model / Reference
- 30002-01 FDA UDI
- Description
- Low Retention Insert, LOCATOR R-Tx Attachment System FDA UDI
Identifiers
- Catalog Number
- 30002-01 FDA UDI
- Primary DI / UDI-DI
- 00840481109942 FDA UDI
- FDA Product Code
- EGG FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3165 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
High-level Disinfectant FDA UDI
Category: Dental implant suprastructure, permanent, preformed
LOCATOR R-Tx by Zest Anchors, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Zest Anchors, LLC
Sources (1)
- FDA UDI 55dfde50-401c-494e-aa75-85e4386a139e 35 fields · synced Jun 9, 2026