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APIXIA DIGIREX

Model 108MUS · DENTAMERICA, INC. · DI 00850461008066

MUH — System, X-Ray, Extraoral Source, Digital · Class II · 21 CFR 872.1800

UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

11222023-08: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 1/device08100204
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2023-0802
2023-1001
2026-0201
2026-0401
This device (reports/month)Average device in MUH (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — DENTAMERICA, INC.

  • NAI 2019-02-12 Dentamerica · 0 citations
  • NAI 2019-02-12 Dentamerica · 0 citations
  • NAI 2014-08-25 Dentamerica · 0 citations
  • NAI 2014-08-25 Dentamerica · 0 citations
  • NAI 2011-12-20 Dentamerica · 0 citations
  • NAI 2011-12-20 Dentamerica · 0 citations