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Elos Accurate Pre-Milled Blank

Elos Medtech Pinol A/S · Model PMB-NBA30-1 · UDI-DI 05712821017444

NHA Prescription

510(k) clearances

8,407

Adverse events (1 deaths)

225

Recalls

378

Facilities

Description

The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.

Recalls

Date	Firm	Reason
2026-07-13	Straumann USA LLC	There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the i
2026-03-27	Straumann USA LLC	Includes an incorrect screw seat interface.
2026-03-27	Straumann USA LLC	Includes an incorrect screw seat interface.
2026-03-17	Straumann USA LLC	A material mix-up had occurred during the manufacturing of Straumann Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorre
2026-03-17	Straumann USA LLC	A material mix-up had occurred during the manufacturing of Straumann Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorre
2025-09-30	Prismatik Dentalcraft, Inc.	Incorrect titanium screw, packaged with dental implant.
2025-06-25	Preat Corp	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
2025-06-24	Preat Corp	Due to manufacturing error, digital analog rotational feature is 180 degrees off.
2025-04-17	Straumann USA LLC	Incorrect blister labelling.
2025-04-02	Preat Corp	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 ass

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.