510(k) Report

FDA applicant

The Straumann Co.

Cambridge, MA15 decisions1992–20048 recalls

FDA records 15 decisions for The Straumann Co. (Cambridge, MA) from 1992 to 2004: 14 510(k) clearances and 1 original PMA approval. Most are in product codes DZE (Implant, Endosseous, Root-Form) and JEY (Plate, Bone). Its devices cite 17 predicates, 1 of them its own earlier devices. 8 recalls are linked to its devices.

FDA’s records also spell it “The Straumann Company”.

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 The Straumann Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for The Straumann Co. since 2007.

Recalls per year

1in 2025

2018: 62025: 1
2007high 6 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — The Straumann Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like The Straumann Co.’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?

  • DZEImplant, Endosseous, Root-Form8decisions
  • JEYPlate, Bone1decision
  • DZLScrew, Fixation, Intraosseous1decision
  • GDMNeedle, Aspiration And Injection, Reusable1decision
  • LYCBone Grafting Material, Synthetic1decision
  • NHAAbutment, Implant, Dental, Endosseous1decision

Also: OAT (1), NQA (1).

Whose devices does it build on?

Its devices cite 17 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 27 times; 1 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.

  • K962023Plastic Protection Healing CapsThe Straumann Co. · 19964cite it
  • K920768Hollow Screw Implants 6MM, 14MM, 16MMThe Straumann Co. · 19924cite it
  • K955281Endosseous Dental Implant & AccessoriesThe Straumann Co. · 19963cite it
  • K955369MemfixThe Straumann Co. · 19963cite it
  • K960634Titanium Healing CapsThe Straumann Co. · 19963cite it
  • K041070Straumann Temporary CopingThe Straumann Co. · 20043cite it

What has FDA decided for it lately?

  • K041070Straumann Temporary CopingThe Straumann Co. · 2004
  • K040646Straumann GranulesThe Straumann Co. · 2004
  • K040469The Straumann Ortho Implant SystemThe Straumann Co. · 2004
  • K993862Modus Sagittal Split PlateThe Straumann Co. · 1999
  • P930021Biora Emdogain (R)The Straumann Company · 19967 recalls
  • K962023Plastic Protection Healing CapsThe Straumann Co. · 1996
  • K960634Titanium Healing CapsThe Straumann Co. · 19961 recall
  • K955281Endosseous Dental Implant & AccessoriesThe Straumann Co. · 1996

All 14 as The Straumann Co. →The one decision as The Straumann Company →

What has been recalled?

8 recalls linked to its devices; the latest:

  • P930021Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;Oct 17, 2025Class II
  • P930021Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099Mar 23, 2018Class II
  • P930021Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098WMar 23, 2018Class II
  • P930021Straumann¿ Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.115Mar 23, 2018Class II
  • P930021Straumann¿ Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Number 075.114WMar 23, 2018Class II
  • P930021Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116WMar 23, 2018Class II

Other applicant names beginning “The”

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

Straumann USA 66Straumann USA, LLC (On Behalf of Institut Straumann Ag) 5Straumann Manufacturing, Inc. 4Straumann Institute, Ltd. 1