Search Results
Found 6 results
510(k) Data Aggregation
K Number
K150295Device Name
LOCATOR RTx
Manufacturer
ZEST ANCHORS, INC.
Date Cleared
2015-07-24
(168 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
ZEST ANCHORS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LOCATOR® RTx Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla.
LOCATOR® RTx Attachment System is compatible with the following implant systems.
| Implant Manufacturer: | System: |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| BioHorizons | Internal Hex (3.0, 3.5, 4.5, 5.7 mm)<br>External Hex (3.5, 4.0, 5.0 mm) |
| Biomet 3i | Certain Internal (3.4, 4.1, 5.0, 6.0 mm)<br>External Hex (3.4, 4.1, 5.0, 6.0 mm) |
| Camlog | Camlog and Conelog; (3.3, 3.8, 4.3, 5.0 mm)<br>iSy (3.8, 4.4, 5.0 mm) |
| Dentsply | Ankylos (3.5, 4.5, 5.5, 7.0 mm)<br>XiVE/FRIALIT-2 (3.4, 3.8, 4.5, 5.5 mm)<br>Astra Tech OsseoSpeed EV (3.6, 4.2, 4.8 mm) |
| MIS Implants | Internal Hex (3.75, 4.5 mm) |
| Nobel Biocare | Replace: Internal (3.5, 4.3, 5.0, 6.0 mm),<br>NobelActive: Internal Conical (3.0, 3.5, 4.3, 5.0 mm),<br>Brånemark: External Hex (3.3, 3.75, 4.0, 5.0 mm) |
| Straumann | Tissue Level (3.5, 4.8, 6.5 mm)<br>Bone Level (3.3, 4.1, 4.8 mm) |
| Zimmer | Tapered Screw Vent: Internal Hex (3.5, 4.5, 5.7 mm)<br>Spline (3.25, 4.0, 5.0 mm)<br>Swiss Plus: Internal Octagon (3.8, 4.8 mm) |
Device Description
LOCATOR® RTx implant attachment system, consists of abutments, nylon or PEEK liners and denture caps to serve in a similar function to LOCATOR® as a resilient attachment for endosseous implants. All LOCATOR RTx abutments are made of titanium alloy and have the same coronal double ridge retention design that attaches to the overdenture component. The threaded apical end of the abutment connects to the implant and is specific to each compatible implant system and diameter. LOCATOR RTx is designed to accommodate a path of insertion on implants that are divergent up to 30° unless prohibited by the implant manufacturer. LOCATOR RTx abutments are provided with either TiCN or TiN coating and are available in six cuff heights (1, 2, 3, 4, 5, and 6 mm). They are provided in diameters 3.0 - 7.0 mm as shown in the compatibility table above.
Ask a Question
K Number
K083324Device Name
LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM
Manufacturer
ZEST ANCHORS, INC.
Date Cleared
2009-02-25
(105 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
ZEST ANCHORS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Locator Implant Anchor Abutment for Endosseous Dental Implants is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla.
The Locator Implant Bar Attachment System for Endosseous Dental Implants is appropriate for use with overdentures or partial dentures retained in whole or in part by bar splinted endosseous implants in the mandible or maxilla.
Device Description
Not Found
Ask a Question
K Number
K072878Device Name
MODIFICATION TO: LOCATOR IMPLANT ANCHOR
Manufacturer
ZEST ANCHORS, INC.
Date Cleared
2007-12-03
(55 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
ZEST ANCHORS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K042466Device Name
X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE
Manufacturer
ZEST ANCHORS, INC.
Date Cleared
2004-11-24
(72 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
ZEST ANCHORS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The X-2 Implant Attachment is designed for use with overdentures or partial dentures, retained in whole or in part by endosseous implants in the mandible or maxilla.
The X-2 Bar Attachment System is designed for use with overdentures or partial dentures retained in whole or in part by bar splinted endosseous implants in the mandible or maxilla.
The X-2 Distal Extension Attachment System is designed for use with partial dentures retained in whole or in part by bar splinted endosseous implants and crowned roots with a distal extension in the mandible or maxilla.
Device Description
Not Found
Ask a Question
K Number
K033699Device Name
LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587, 08588, 08586
Manufacturer
ZEST ANCHORS, INC.
Date Cleared
2004-04-22
(149 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
ZEST ANCHORS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Locator Bar Attachment System is designed for use with overdentures or partial dentures retained in whole or in part by bar splinted endosseous implants in the mandible or maxilla.
Device Description
Not Found
Ask a Question
K Number
K994257Device Name
LOCATOR IMPLANT ANCHOR
Manufacturer
ZEST ANCHORS, INC.
Date Cleared
2000-03-17
(92 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
ZEST ANCHORS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Locator Implant Anchor abutment for endosseous dental implants is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla.
Device Description
The Locator Implant Anchor is an abutment for endosseous implants.
Ask a Question
Page 1 of 1