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Anthos

Model RX DC · CEFLA SOCIETA' COOPERATIVA · DI 08033837931720

EHD — Unit, X-Ray, Extraoral With Timer · Class II · 21 CFR 872.1800

UDILibrary device dossier · generated 2026-09-07 · 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.

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-01	0	1
2019-06	0	2
2020-02	0	2
2021-12	0	1.33
2022-02	0	1
2022-12	0	2
2023-08	0	2
2023-10	0	1
2026-02	0	1
2026-04	0	1

This device (reports/month)Average device in EHD (reports/device/month)

Regulatory clearances

None linked in the loaded window.

Predicate lineage

K163519 — cites (transitively): K080076 (d1), K120318 (d1), K030634 (d2), K043092 (d2) — cited as predicate by K182206

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — CEFLA SOCIETA' COOPERATIVA

Nothing in the loaded window.