FDAJune 25, 2024device
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-co...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
preat
UPCs
0084209217869000842092181898008420921819590084209217873700842092178775008420921788120084209217889800842092178997008420921789280084209217895900842092182130
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDANobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 90006622025-06-25
- FDAPreat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only2025-06-24
- FDABiomet 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.2025-04-02
- FDA9006767 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.2024-04-10
- FDAPreat Nobel Active/Conical-compatible RP Titanium Blank, REF 90009672024-02-09
- FDAPreat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental2023-07-18
- FDAPreat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental2023-07-18
- FDAPreat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental2023-07-18
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →