# K200827: LOCATOR R-Tx

- Pathway: 510(k) (Special)
- Applicant: Ivory Super Holdco, Incp.
- Decided: Sep 2, 2020 after 156 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K894595 (1990). 152 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 154 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150295: LOCATOR RTx, Zest Anchors, Inc. (2015) Summary page 5.

## Most influential descendants
- K253774: Elos Accurate® Denture Fixation System (2026), 0 descendants of its own

## Indications for use
The LOCATOR R-Tx® 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 R-Tx Attachment System is compatible with the following implant systems: Implant Manufacturer: Implant System: Implant Diameters (Ø mm): Ace Surgical Infinity OCTAGON (3.3, 4.1, 4.8) Infinity TRI-CAM (3.5, 4.3, 5.0) Infinity External Hex (3.3, 3.75, 4.0, 4.75) Infinity Internal Hex (3.7, 4.1, 4.7, 5.1) Avinent Biomimetic Ocean (3.3, 3.5, 4.0, 4.5, 5.0) Biomimetic Coral (3.3, 3.8, 4.0, 4.2, 4.8) Biohorizons Tapered Internal (3.0) Tapered Plus (3.8) Laser-Lok (3.0) Biomet 3i 3iT3, NanoTite, OSSEOTITE (3.25, 3.75, 4.0) Blue Sky Bio Quattro (3.3, 4.1, 4.8) One Stage (3.3, 4.1, 4.8) Camlog SCREW-LINE ROOT-LINE 2 (3.3, 3.8, 4.3, 5.0) SCREW-LINE (3.3, 3.8, 4.3, 5.0) Dentsply Astra Tech OsseoSpeed EV (3.6, 4.2, 4.8) Xive Frialit-2 (3.4, 3.8, 4.5, 5.5) Ankylos C/X (3.5) Astra Tech OsseoSpeed TX (3.5, 4.0, 4.5, 5.0) Hiossen, Inc. SS (3.5, 4.0, 4.5) ET, TS (3.5, 4.0, 4.5, 5.0, 6.0, 7.0) US (3.5, 3.3, 4.5, 4.0, 5.0, 6.0, 7.0) Implant Direct Swish Plus (4.1, 4.8) SwishTapered (4.1, 4.8) InterActive (3.2, 3.7, 4.3, 5.0) ReActive (3.7, 4.2, 4.7, 5.7) Replant (3.5, 4.3, 5.0) Legacy 1, 2, 3, 4 (3.7, 4.2) Legacy 2, 3, 4 (3.2, 4.7, 5.2) Legacy 1, 3 (5.7) Legacy 2, 4 (5.7, 7.0) Legacy 1 (4.7) IDS MegaGen Any Ridge (3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0) Keystone PrimaConnex (3.5, 4.1, 5.0) Genesis (3.5) TILOBEMAXX (7.0, 8.0, 9.0) MIS C1 (3.3, 3.75, 4.2) V3 (3.3, 3.9, 4.3, 5.0) SEVEN (3.3) M4 (3.3) Nobel Replace, Replace Select, NobelSpeedy (3.5, 4.3, 5.0) NobelActive, NobelParallel CC, NobelReplace CC (3.5, 4.3, 5.5) Branemark, Nobel Speedy, Groovy (3.3, 3.75, 4.0, 5.0) OCO Biomedical Engage (3.25, 4.0, 5.0) Southern Implants Tri-Nex (3.5, 4.3, 5.0) Tri-MAX7 (7.0) External Hex (3.75, 4.0, 5.0, 5.1, 6.0, 7.0, 8.0) Straumann Roxolid SLActive, Roxolid SLA (3.3, 4.1, 4.8) Zimmer Trabecular Metal, Tapered Screw-Vent, Screw-Vent, Advent (3.7, 4.1, 4.7, 6.0) Spline Reliance Cylinder (3.25, 4.0, 5.0) Spline Twist (3.75)

Source page: https://510kreport.com/device/K200827
Methodology: https://510kreport.com/methodology