Identity
- Trade Name
- LOCATOR R-Tx FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Attachment System, RP, Tissue Level, Blue Sky Bio One Stage, 4mm cuff FDA UDI
- Model / Reference
- 30906-04 FDA UDI
- Description
- Attachment System, RP, Tissue Level, Blue Sky Bio One Stage, 4mm cuff FDA UDI
Identifiers
- Catalog Number
- 30906-04 FDA UDI
- Primary DI / UDI-DI
- 00840481120763 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Contains Latex
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 — 4 Millimeter FDA UDI
Category: Dental implant suprastructure, permanent, preformed
The LOCATOR R-Tx is a prefabricated dental implant suprastructure, or permanent intermediate fixture level between a dental implant and final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural components like abutment screws, bars, and rings, which are often made of titanium, plastic, or gold alloy. The device is designed for permanent use and may be referred to as an abutment assembly or mesostructure.
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 (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zest Anchors, LLC
Sources (1)
- FDA UDI 7c2b0ae2-f77d-409f-a1f4-6b44b389eb2f 36 fields · synced Jul 21, 2026