DENTAPLAST HOT, MODEL 16-XXX— 510(k) K052780

Substantially Equivalent

Bredent-Products For the Dental Technician Laborat

FDA 510(k) clearance K052780 for DENTAPLAST HOT, MODEL 16-XXX, Substantially Equivalent on 2005-12-21. Applicant: Bredent-Products For the Dental Technician Laborat. Device class: 2.

Clearance details

Applicant: Bredent-Products For the Dental Technician Laborat
Product code: Code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
Advisory panel: Dental
Date received: 2005-10-03
Decision date: 2005-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuttlingen, DE

Download summary PDF View on FDA.gov ↗

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More clearances from Bredent-Products For the Dental Technician Laborat

K052779 — BRECOMP2005-12-20
K052781 — BREFORMANCE2005-12-09

Adverse events under product code EBI

product code EBI

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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