FDA Device Intelligence
HomeDevice types › NHA

Abutment, Implant, Dental, Endosseous

FDA product code NHA · Class 2 · Dental

99,398
Registered devices
8,407
Adverse events
225
Recalls
713
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-07-13Straumann USA LLCThere 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
2026-03-27Straumann USA LLCIncludes an incorrect screw seat interface.
2026-03-27Straumann USA LLCIncludes an incorrect screw seat interface.
2026-03-17Straumann USA LLCA material mix-up had occurred during the manufacturing of Straumann Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot
2026-03-17Straumann USA LLCA material mix-up had occurred during the manufacturing of Straumann Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot
2025-09-30Prismatik Dentalcraft, Inc.Incorrect titanium screw, packaged with dental implant.
2025-06-25Preat CorpEngaging 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 th
2025-06-24Preat CorpDue to manufacturing error, digital analog rotational feature is 180 degrees off.
2025-04-17Straumann USA LLCIncorrect blister labelling.
2025-04-02Preat CorpDue to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the mating screw to have a shorter engagement

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.