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Straumann USA LLC: Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments

Medical DevicesSource: FDA (device) · Date: 2026-05-06

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Straumann USA LLC
Product
Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments
Reason / hazard
Includes an incorrect screw seat interface.
Classification
Class II
Status
Ongoing
Distribution / sold at
US distribution to AL, AZ, FL, HI, LA, MD, OH, VA.
Recall initiated
2026-03-27
Code info
Article 010.0304. UDI: (01)07630031779977(11)YYMMDD(10)XXXXX. Project Numbers: 28000US_00811_00_b00, 28000US_00811_01_b00, 28000US_00426_00_b00, 28000US_00449_00_b00, 28000US_01266_00_b00.
Product quantity
5 units
Voluntary mandated
Voluntary: Firm initiated
City
Andover
State
MA
Country
United States
Event id
98681
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