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Angle-Ease Colorz Adjustable HVE Tips

Model 70-42609 · PRACTICON, INC. · DI 00723896009949

EHZ — Evacuator, Oral Cavity · Class I · 21 CFR 872.6640

UDILibrary device dossier · generated 2026-09-15 · 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.

01112020-03: 0 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 1/device0312
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-0301
2023-1201
This device (reports/month)Average device in EHZ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — PRACTICON, INC.

  • VAI 2026-02-26 Practicon Inc · 3 citations
  • VAI 2026-02-26 Practicon Inc · 3 citations
  • NAI 2017-01-24 Practicon Inc · 0 citations
  • NAI 2017-01-24 Practicon Inc · 0 citations