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ACE

Model 9700042 · ACE SURGICAL SUPPLY CO., INC. · DI 00614950031283

EAX — Mirror, Mouth · Class I · 21 CFR 872.4565

UDILibrary device dossier · generated 2026-09-16 · 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.

01122022-12: 0 reports for this device; peer average 1.5/device2026-06: 0 reports for this device; peer average 1/device1206
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2022-1201.5
2026-0601
This device (reports/month)Average device in EAX (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — ACE SURGICAL SUPPLY CO., INC.

  • VAI 2015-07-23 Ace Surgical Supply Co., Inc. · 5 citations