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RP Natural Profile Abutment 6.0mm x 4.0mm

STERNGOLD DENTAL LLC · Model 904247 · UDI-DI 00841549110672

NHA Prescription

510(k) clearances

8,407

Adverse events (1 deaths)

225

Recalls

378

Facilities

Description

The RP Natural Profile Abutment enables the clinician to restore cases that are periodontally and aesthetically demanding. This versatile system permits the development of an emergence profile which is in harmony with the soft tissue. Final margination can be prepared to accurately follow the gingival contours in order to achieve maximum aesthetics. Intended for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws directly into endosseous implants or they screw into Abutment Bases which are screwed into endosseous implants.

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.