PREAT Corporation
Santa Maria, CA, US
PREAT Corporation appears in FDA device records in Santa Maria, CA. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 11 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for PREAT Corporation between 2022 and 2025. The busiest year on record is 2022, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2022 | 1 |
| 2025 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2918719 | 2918719 | PREAT Corporation | 2625 Skyway Drive, Santa Maria, CA 93455 US | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NHAAbutment, Implant, Dental, Endosseous
- NDPAccessories, Implant, Dental, Endosseous
- EGGAttachment, Precision, All
- EHOBar, Preformed
- EJLBur, Dental
- PNPDental Abutment Design Software For Dental Laboratory
- DZADrill, Dental, Intraoral
- EILGauge, Depth, Instrument, Dental
- EJBHandle, Instrument, Dental
- DZEImplant, Endosseous, Root-Form
- DZNInstruments, Dental Hand
- NOKMaterial, External Aesthetic Restoration, No Adhesive
- EBHMaterial, Impression Tray, Resin
- ELRPost, Root Canal
- EIDSyringe, Restorative And Impression Material
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2514-2025 | NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662 | 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. | Class II | Open, Classified | |
| Z-2107-2025 | Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only | Due to manufacturing error, digital analog rotational feature is 180 degrees off. | Class II | Open, Classified | |
| Z-1987-2025 | Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled 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. | 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. | Class II | Open, Classified | |
| Z-2687-2024 | Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straumann Tissue-Level-compatible WN Digital Analog, REF 9001303 3i Certain-compatible 5.0mm Digital Analog, REF 9001903 3i Certain-compatible 6.0mm Digital Analog, REF 9002003 Astra-compatible 3.0mm Digital Analog, REF 9002103 Astra-compatible Aqua 3.5/4.0mm Digital Analog, REF 9002203 Astra-compatible Lilac 4.5/5.0mm Digital Analog, REF 9002203 BioHorizons-compatible 3.0mm Digital Analog, REF 9005203 Legacy-compatible 3.0mm Digital Analog, REF 9005303 Digital Analog - BioHorizons - 3.5mm, Digital Analog - BioHorizons - 4.5mnm, REF 9005403 Legacy-compatible 3.5mm Digital Analog, REF 9005503 Legacy-compatible 5.7mm Digital Analog, REF 9008503 Astra EV 4.8mm Milled Titanium Abutment REF 9006767 Digital analogs are used for visual inspection of abutments and restoration in the dental laboratory. | 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. | Class II | Open, Classified | |
| Z-2318-2024 | 9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation. | Due to incorrect milled titanium abutment being packaged and labeled. | Class II | Open, Classified | |
| Z-1321-2024 | Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967 | 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. | Class II | Open, Classified | |
| Z-0154-2024 | Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental | The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage | Class II | Open, Classified | |
| Z-0153-2024 | Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental | The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage | Class II | Open, Classified | |
| Z-0152-2024 | Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental | The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage | Class II | Open, Classified | |
| Z-1285-2023 | Neodent GM X 6mm Engaging Titanium Base, REF: 9007162 | 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. | Class II | Open, Classified | |
| Z-1226-2023 | PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue. | Product is labeled with an incorrect expiration date. | Class III | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain