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Manufacturer

Nobel Biocare: the manufacturer

Nobel Biocare makes the implant systems explained on this site. It is an independent third party with no connection to this website.

Company facts

Company (FDA filings)Nobel Biocare AG / Nobel Biocare Services AG, Kloten, Switzerland1
Parent companyEnvista Holdings Corporation2
Sister brands in Envista's implant businessImplant Direct, Alpha-Bio Tec3
FDA implant and abutment 510(k)sSince 1997 (see regulatory records)4
Recall records (FDA)76, of which 74 completed5
Precision manufacturing clean room
Illustration of precision medical manufacturing. Not a Nobel Biocare facility.

Product families today

Relationship with this website

None. Nobel Biocare does not own, operate, sponsor or endorse this website, and has no relationship with our clinical partner that we are aware of. We use its product names only to identify the products we explain.

Last updated 28 Sep 2026.

Sources

  1. Regulatory recordFDA 510(k) K212125 — Nobel Biocare Dental Implant Systems Portfolio – MR Conditional — U.S. Food and Drug Administration, 2021-09-24. Accessed 28 Sep 2026.
  2. Manufacturer documentationEnvista Holdings — Our company — Envista Holdings Corporation, 2026-09-28. Accessed 28 Sep 2026.
  3. Manufacturer documentationEnvista — Specialty Products & Technology (Nobel Biocare, Implant Direct, Alpha-Bio Tec) — Envista Holdings Corporation. Accessed 28 Sep 2026.
  4. Regulatory recordopenFDA 510(k) database — records with applicant "Nobel Biocare" (endosseous implants DZE and abutments NHA) — U.S. Food and Drug Administration (openFDA), 2026-09-28. Accessed 28 Sep 2026.
  5. Regulatory recordopenFDA device recall database — records with recalling firm "Nobel Biocare" (76 records) — U.S. Food and Drug Administration (openFDA), 2026-09-28. Accessed 28 Sep 2026.

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