Rhondium One-Visit-Crown(OVC)— 510(k) K143694

Substantially Equivalent

Rhondium, Ltd.

FDA 510(k) clearance K143694 for Rhondium One-Visit-Crown(OVC), Substantially Equivalent on 2015-05-15. Applicant: Rhondium, Ltd.. Device class: 2.

Clearance details

Applicant: Rhondium, Ltd.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2014-12-24
Decision date: 2015-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Katikati, NZ

Download summary PDF View on FDA.gov ↗

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More clearances from Rhondium, Ltd.

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Recalls naming K143694

K-number listed on FDA's recall record

Z-0708-2020 — Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile, Rx. The firm name on the label is Rhondium Ltd., Katikati, New Zealand.Class II·Completed·RHONDIUM LIMITED·20190131

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143694.

Data sourced from openFDA. This site is unofficial and independent of the FDA.