Device product

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

Z-1994-2026

March 27, 2026

Class II

Product summary

Firm: Straumann USA LLC
Event: Event 98681
Status: Ongoing
Classification: Class II
Quantity: 5 units
Official record key: device-enforcement:Z-1994-2026

Official wording

Reason: Includes an incorrect screw seat interface.

Code information: 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.

Distribution pattern: US distribution to AL, AZ, FL, HI, LA, MD, OH, VA.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Includes an incorrect screw seat interface.