510(k) Report

FDA applicant

Straumann USA, LLC (On Behalf of Institut Straumann Ag)

Andover, MA5 decisions2007–20200 recalls

FDA records 5 decisions for Straumann USA, LLC (On Behalf of Institut Straumann Ag) (Andover, MA) from 2007 to 2020: 5 510(k) clearances. Most are in product codes NHA (Abutment, Implant, Dental, Endosseous) and NPK (Barrier, Synthetic, Intraoral). Since 2016 its 510(k)s took a median of 163 days from receipt to decision, against 188 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Straumann USA (On Behalf of Institut Straumann Ag)”.

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 Straumann USA, LLC (On Behalf of Institut Straumann Ag)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2007: 12010: 12017: 22020: 1
2007high 2 (2017) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Straumann USA, LLC (On Behalf of Institut Straumann Ag) by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Straumann USA, LLC (On Behalf of…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NHAAbutment, Implant, Dental, Endosseous3decisions
  • NPKBarrier, Synthetic, Intraoral1decision
  • DZEImplant, Endosseous, Root-Form1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 163 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 188 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K171769Straumann PURE Ceramic ImplantsStraumann USA, LLC (On Behalf of Institut Straumann Ag) · 20172cite it
  • K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag) · 20172cite it

What has FDA decided for it lately?

  • K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag) · 2020
  • K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag) · 2017
  • K171769Straumann PURE Ceramic ImplantsStraumann USA, LLC (On Behalf of Institut Straumann Ag) · 2017
  • K101956Straumann MembragelStraumann USA (On Behalf of Institut Straumann Ag) · 2010
  • K071919P.004 AbutmentsStraumann USA (On Behalf of Institut Straumann Ag) · 2007

All 3 as Straumann USA, LLC (On Behalf of Institut Straumann Ag) →All 2 as Straumann USA (On Behalf of Institut Straumann Ag) →

Other applicant names beginning “Straumann”

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

Straumann USA 66The Straumann Co. 15Straumann Manufacturing, Inc. 4Straumann Institute, Ltd. 1