PREAT Corporation
United Statesfrom the FDA registration address FDA establishment FEI 2918719
- Devices
- 4,222
- Registrations
- FDA
- FDA recalls
- 1111 ongoing
What PREAT Corporation makes
PREAT Corporation manufactures dental implant suprastructures, including permanent and temporary preformed components, as well as dental prosthesis/implant abutment screws, resilient and bar/sliding dental precision attachments, and dental implant analogs such as intraoral-scanning and single-use abutment analogs.
The company's devices are classified as Class I and Class II medical devices and are listed in the FDA's Unique Device Identification (FDA UDI) system. PREAT Corporation is based in the United States.
Catalogue
Search and filter all 4,222 devicesShowing 1-50 of 4,222
Company details
- FDA FEI number
- 2918719
- Address
- 2625 Skyway Drive, Santa Maria, CA, 93455
FDA recalls
FDA recall records list 11 recalls initiated by PREAT Corporation, the earliest on 2023-02-01 and the most recent on 2025-06-25. By recorded status: 11 ongoing. The reasons filed fall into these groups: labeling or instructions for use, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 5
- 2024 3
- 2025 3
- 2026 0
2025
- 25 Jun 2025 Z-2514-2025 Class II Ongoing 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 not fit onto the abutment in the correct orientation, resulting in restoration delay.
- 24 Jun 2025 Z-2107-2025 Class II Ongoing Due to manufacturing error, digital analog rotational feature is 180 degrees off.
- 2 Apr 2025 Z-1987-2025 Class II Ongoing 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.
2024
- 25 Jun 2024 Z-2687-2024 Class II Ongoing Due to a manufacturing issue, the product has a out of specification rotation of the digital analog used to visually inspect dental abutments and restorations.
- 10 Apr 2024 Z-2318-2024 Class II Ongoing Due to incorrect milled titanium abutment being packaged and labeled.
- 9 Feb 2024 Z-1321-2024 Class II Ongoing 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.
2023
- 18 Jul 2023 Z-0152-2024 Class II Ongoing The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
- 18 Jul 2023 Z-0153-2024 Class II Ongoing The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
- 18 Jul 2023 Z-0154-2024 Class II Ongoing The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
- 21 Feb 2023 Z-1285-2023 Class II Ongoing 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 installed on the implant, may lead to abutment/screw fracture, which could result in the abutment/screw/crown being ingested by the patient.
Show all 11 recalls
2023
- 1 Feb 2023 Z-1226-2023 Class III Ongoing Product is labeled with an incorrect expiration date.
Full distribution text
- 1 Feb 2023 Z-1226-2023 Class III Ongoing Product is labeled with an incorrect expiration date.
Frequently asked questions
How many devices does PREAT Corporation have in the registry?
The registry currently lists 4222 devices for PREAT Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list PREAT Corporation's devices?
Among its 50 most recently registered devices, PREAT Corporation has devices listed in FDA GUDID (50 devices).
What risk classes do PREAT Corporation's devices fall under?
Among its 50 most recently registered devices, the classes recorded for PREAT Corporation's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for PREAT Corporation?
FDA recall records list 11 recalls initiated by PREAT Corporation, the most recent initiated on 25 Jun 2025. 11 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from PREAT Corporation in the registry?
The most recently registered devices listed for PREAT Corporation include Preat 9001230-10, Preat 9003731-100, Preat 710106 and Preat 710045.