510(k) Report

FDA applicant

Nobel Biocare Services AG

Kloten, CH5 decisions2021–20232 recalls

FDA records 5 decisions for Nobel Biocare Services AG (Kloten, CH) from 2021 to 2023: 5 510(k) clearances. Most are in product codes KCT (Sterilization Wrap Containers, Trays…) and NHA (Abutment, Implant, Dental, Endosseous). Since 2016 its 510(k)s took a median of 204 days from receipt to decision, against 142 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 2 of them its own earlier devices. 2 recalls are 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 Nobel Biocare Services AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2021: 22022: 22023: 1
2021high 2 (2021) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

1in 2025

2022: 12025: 1
2021high 1 (2022) · low 0 (2021)2026

Class I Class II/III not classified

FIG. 1 — Nobel Biocare Services AG by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories2decisions
  • NHAAbutment, Implant, Dental, Endosseous2decisions
  • DZEImplant, Endosseous, Root-Form1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 204 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 142 days; 2 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 15 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 2 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.

  • K212932Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet TrayNobel Biocare Services AG · 20212cite it
  • K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG · 20212cite it
  • K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG · 20221cites it

What has FDA decided for it lately?

  • K231219NobelZygoma PureSet™ TrayNobel Biocare Services AG · 2023
  • K220339Esthetic Abutments Nobel Biocare N1Nobel Biocare Services AG · 2022
  • K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG · 2022
  • K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG · 20212 recalls
  • K212932Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet TrayNobel Biocare Services AG · 2021

All 5 as Nobel Biocare Services AG →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K211109. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm .…Jan 10, 2025Class II
  • K211109Nobel Biocare N1 TiUltra TCC NP 3.5x13mmJul 25, 2022Class II

Other applicant names beginning “Nobel”

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

Nobel Biocare AB 96Nobel Biocare Uas, Inc. 31Nobel Scientific Industries, Inc. 23Nobel Biocare USA, LLC 9Nobel Biocare C/O Medicim NV 1