# K183518: Preat Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Preat Corporation
- Decided: Mar 18, 2019 after 90 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K960026 (1996). 355 ancestors in all.
22 later devices descend from it; 4 cite it directly.
0 of 378 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170588: DESS Dental Smart Solutions, Terrats Medical SL (2017) Summary page 5.
- K120414: Osseospeed Plus, Astra Tech AB (2012) Summary page 5.
- K161416: Multi-unit Abutment Plus, Nobel Biocare AB (2017) Summary page 5.
- K151621: BioHorizons CAD/CAM Abutments, BioHorizons Implant Systems, Inc. (2016) Summary page 5.
- K100993: Inclusive Titanium Abutments for Astra Tech Osseospeed Implants, Prismatik Dentalcraft, Inc. (2010) Summary page 5.

## Most influential descendants
- K193096: S.I.N. Dental Implant System (2020), 8 descendants of its own
- K200817: URIS OMNI Narrow System & Prosthetic (2020), 6 descendants of its own
- K211921: S.I.N. Dental Implant System (2021), 5 descendants of its own
- K222231: S.I.N. Dental Implant System (2022), 4 descendants of its own
- K193335: Sherlock (2020), 3 descendants of its own

## Recalls of this device
- Jun 25, 2025 · Class II · Z-2514-2025: Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the flat is on the wrong side of the post, the crown will
- Apr 2, 2025 · Class II · Z-1987-2025: Due to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the mating screw to have a shorter engagement length into the associated implant.
- Feb 9, 2024 · Class II · Z-1321-2024: Due to a manufacturing issue, the screw seat location on the abutment product may be too high, causing mating screw to have a shorter engagement length into the associated implant.

## Indications for use
Preat Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations. The Titanium Base abutments consists of two major parts. Specifically, the titanium base and mesostructured components make up a two-piece abutment. All digitally designed custom abutments, superstructures, and/or hybrid crowns for use with Titanium Base or Titanium Blank are to be sent to a Preat validated milling center for manufacture. Compatible Implant Systems 3i OSSEOTITE® Certain®: implant body diameters 3.25, 4.0, 5.0, and 6.0 mm; implant platform diameters 3.4, 4.1, 5.0, and 6.0 mm. Astra Tech OsseoSpeed™: implant body diameters 3.0, 3.5, 4.0, 4.5, and 5.0 mm; implant platform diameters 3.0, 3.5/4.0, and 4.5/5.0 mm. BioHorizons Tapered Internal: implant body diameters 3.0, 3.5, and 4.0 mm; implant platform diameters 3.0, 3.5, and 4.5 mm. HIOSSEN ET III: implant body diameter 3.5 mm (Mini platform), and 4.0, 4.5, 5.0, 6.0, and 7.0 mm (Regular platform). Implant Direct Legacy: implant body diameters 3.2, 3.7, 4.2, 4.7, 5.2, 5.7, and 7.0 mm; implant platform diameters 3.0, 3.5, 4.5, and 5.7 mm. MegaGen AnyRidge: implant body diameters 3.5, 4.0, 4.5, 5.0, and 5.5 mm; implant platform diameter 3.5 mm. Neoss: implant body diameters 3.5, 4.0, 4.5, 5.0, and 5.5 mm; implant platform diameter 4.1 mm. NobelActive®: implant body diameter 3.5 mm (NP platform), and 4.3 and 5.0 mm (RP platform). Nobel Replace™: implant body diameter 3.5 mm (NP platform); 4.0, 4.3, and 5.0 mm (RP platform); 5.0 mm (WP platform); and 6.0 mm (6.0 platform). Straumann® Bone Level: implant body diameter 3.3 mm (NC platform), and 4.1 and 4.8 mm (RC platform). Straumann® Tissue Level: implant body diameters 3.3, 4.1, and 4.8 mm (RN platform), and 4.8 and 6.5 mm (WN platform). Zimmer Screw-Vent®/Tapered Screw-Vent®: implant body diameters 3.3, 3.7, and 4.1 mm (3.5 platform); 4.7 mm (4.5 platform); and 6.0 mm (5.7 platform).

Source page: https://510kreport.com/device/K183518
Methodology: https://510kreport.com/methodology