# K220823: Preat Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Preat Corporation
- Decided: Oct 26, 2022 after 219 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K960026 (1996). 356 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 358 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183518: Preat Abutments, Preat Corporation (2019) Summary page 4.

## Most influential descendants
- K243824: Preat Abutments (2025), 0 descendants of its own

## Recalls of this device
- Jun 24, 2025 · Class II · Z-2107-2025: Due to manufacturing error, digital analog rotational feature is 180 degrees off.
- Apr 10, 2024 · Class II · Z-2318-2024: Due to incorrect milled titanium abutment being packaged and labeled.
- Jul 18, 2023 · Class II · Z-0153-2024: The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
- Jul 18, 2023 · Class II · Z-0152-2024: The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
- Jul 18, 2023 · Class II · Z-0154-2024: The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
- Feb 21, 2023 · Class II · Z-1285-2023: Engaging titanium base contains a dimensional condition that allows vertical movement of the titanium base after the prosthetic screw is torqued to the recommended value, which if undetected and insta

## 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 the mesostructured components make up a two-piece abutment. All digitally designed custom abutments, superstructures, and/or hybrid crowns for use with Titanium Bases or Titanium Blanks are to be sent to a Preat validated milling center for manufacture.

Source page: https://510kreport.com/device/K220823
Methodology: https://510kreport.com/methodology