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Implant Direct Sybron Manufacturing LLC

2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Implant Direct Sybron Manufacturing LLC and translate it into plain English — free weekly digest, optional same-day alerts.

2025-08-06FDA-DeviceClass II
The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounting/removal of the Drill Stops. The Drill Stop Kit includes the Release Bracket, which is used for mounting and removing Drill Stops, as well as verifying the length of the Drill Stops via a ruler and depth markings. The Drill Stop Kit also allows for optional storage of some DLC drills. Drill Stops: The Drill Stop is a reusable (up to 30 osteotom
The Drill stop kit contains incorrect components.
2023-07-05FDA-DeviceClass II
LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW NE 3.5D, REF: 8735-80NNE; LEGACY SMARTBASE, NE 3.5D 2MML, REF: 8735-82NE LEGACY SMARTBASE NARROW NE 4.5D, REF: 8745-80NNE; LEGACY SMARTBASE. NE 4.5D, REF: 8745-82NE;
Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.

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