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Aproxi 1100 and 4000 Series Dental Inlays

by Aproxi Aps Denmark 510(k)

510(k) K073047

Product code EBF

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK073047 Date7 Aug 2008ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
EBF
Device Class
Class II
Regulation
21 CFR Part 872.3690
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K073047 24 fields · synced 22 Oct 2026