# K253774: Elos Accurate® Denture Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Elos Medtech Pinol A/S
- Decided: May 20, 2026 after 175 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: 14 generations back to K894595 (1990). 153 ancestors in all.
No later device cites it as a predicate yet.
0 of 154 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200827: LOCATOR R-Tx, Ivory Super Holdco, Incp. (2020) Summary page 5.

## Indications for use
The Elos Accurate® Denture Fixation System is intended to retain removable overdentures for patients with partial or complete edentulism. The Elos Accurate® Denture Fixation System is compatible with the implant systems listed in table 1: Astra Tech EV 3.6: platform diameter Ø2.9 mm; implant diameter Ø3.6 mm Astra Tech EV 4.2: platform diameter Ø3.5 mm; implant diameter Ø4.2 mm Astra Tech EV 4.8: platform diameter Ø4.1 mm; implant diameter Ø4.8 mm Astra Tech EV 5.4: platform diameter Ø4.6 mm; implant diameter Ø5.4 mm Straumann BLX RB/WB: platform diameter Ø2.9 mm; implant diameter Ø3.5/Ø3.75/Ø4/Ø4.5/Ø5/Ø5.5/Ø6.5 mm Nobel CC NP: platform diameter Ø3.0 mm; implant diameter Ø3.5/Ø3.75 mm Nobel CC RP: platform diameter Ø3.4 mm; implant diameter Ø4.3/Ø5 mm Nobel CC WP: platform diameter Ø4.4 mm; implant diameter Ø5.5/Ø6 mm Neodent GM: platform diameter Ø3 mm; implant diameter Ø3.5/Ø3.75/Ø4/Ø4.3/Ø5/Ø6/Ø7 mm Zimmer Screw-vent 3.5: platform diameter Ø3.4 mm; implant diameter Ø3.7/Ø4.1 mm Zimmer Screw-vent 4.5: platform diameter Ø4.4 mm; implant diameter Ø4.7 mm Zimmer Screw-vent 5.7: platform diameter Ø5.6 mm; implant diameter Ø6.0 mm

Source page: https://510kreport.com/device/K253774
Methodology: https://510kreport.com/methodology