Cleared Traditional

K052073 - FUTURAPRESS LT

K052073 is an FDA 510(k) clearance for FUTURAPRESS LT, manufactured by Schutz-Dental GmbH. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K052073 · Schutz-Dental GmbH · Dental device
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Oct 2005
Decision
86d
Days
Class 2
Risk

K052073 is an FDA 510(k) clearance for the FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Schutz-Dental GmbH (Rosbach, DE). The FDA issued a Cleared decision on October 26, 2005 after a review of 86 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 Schutz-Dental GmbH devices

FDA 510(k) Submission Details - K052073

510(k) Number K052073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2005
Decision Date October 26, 2005
Days to Decision 86 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 127d · This submission: 86d
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 176
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K052073.
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NATURE-CRYL HI PLUS
K051358 · GC America, Inc. · Jul 2005
PALAIMPACT
K043504 · Heraeus Kulzer, Inc. · Jan 2005
VERSYO.DIRECT
K043295 · Heraeus Kulzer, Inc. · Jan 2005