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The Bell BriefFrom Dr. Jennifer Bell, DDS
MEDIUMRegulatoryTier 1

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 066

SourceFederal Register (dental)Tier 1Hard News

By Health and Human Services Department, Food and Drug Administration

Originally at federalregister.gov

Summary & scoring by The Bell Brief (Dr. Jennifer Bell) using the Drill-Down Protocol (Drill-Down Score) — not the original publisher.

Why it matters for dental

Dental device and material makers (and the practices that buy their products) gain an updated FDA-recognized-standards list they can cite for faster 510(k) clearance; owners and DSO procurement teams should verify whether any new or withdrawn standards affect their preferred implant systems, handpieces, or restorative materials.

Key points

  • Recognition List 066 updates the roster of consensus standards FDA will accept for premarket submissions; manufacturers can declare conformity to these standards to support regulatory clearance.
  • Standards changes can alter the testing or documentation required for common dental devices such as endodontic files, orthodontic brackets, and chair-side CAD/CAM ceramics.
  • Device vendors may re-label or re-certify products after the list update; practices should confirm current regulatory status before bulk purchases or lease renewals.
  • The list does not impose new mandatory requirements but streamlines the pathway for compliant products; non-listed standards may still be used with additional justification.

Who should care

OwnerDSO

Read the original on Federal Register (dental)

Full reporting and any paywall content live on federalregister.gov. We summarize and score; we do not republish.

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