510(k) Report

FDA applicant

Riemser Arzneimittel AG

Durham, NC3 decisions2012–20130 recalls

FDA records 3 decisions for Riemser Arzneimittel AG (Durham, NC) from 2012 to 2013: 3 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and NPM (Bone Grafting Material, Animal Source). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Riemser Arzneimittel AG’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2012: 12013: 2
2012high 2 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Riemser Arzneimittel AG by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Riemser”

FDA records each applicant name separately; these may or may not be the same firm.