Cleared Traditional

K052780 - DENTAPLAST HOT, MODEL 16-XXX

K052780 is an FDA 510(k) clearance for DENTAPLAST HOT, manufactured by Bredent-Products For the Dental Technician Laborat. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K052780 · Bredent-Products For the Dental Technician Laborat · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
79d
Days
Class 2
Risk

K052780 is an FDA 510(k) clearance for the DENTAPLAST HOT, MODEL 16-XXX. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Bredent-Products For the Dental Technician Laborat (Tuttlingen, DE). The FDA issued a Cleared decision on December 21, 2005 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bredent-Products For the Dental Technician Laborat devices

FDA 510(k) Submission Details - K052780

510(k) Number K052780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2005
Decision Date December 21, 2005
Days to Decision 79 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 127d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EBI Resin, Denture, Relining, Repairing, Rebasing

All 210
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