Cleared Traditional

K993827 - UFI GEL HARD

K993827 is an FDA 510(k) clearance for UFI GEL HARD, manufactured by Voco GmbH. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K993827 · Voco GmbH · Dental device
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Jan 2000
Decision
69d
Days
Class 2
Risk

K993827 is an FDA 510(k) clearance for the UFI GEL HARD. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Voco GmbH (Montreal, CA). The FDA issued a Cleared decision on January 20, 2000 after a review of 69 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 Voco GmbH devices

FDA 510(k) Submission Details - K993827

510(k) Number K993827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1999
Decision Date January 20, 2000
Days to Decision 69 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
58d faster than avg
Panel avg: 127d · This submission: 69d
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 239
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K993827.
HARD RELINER
K011277 · S & C Polymer GmbH · Jun 2001
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K992176 · St. George Technology, Inc. · Feb 2000
ENIGMA HI-BASE DENTURE BASE MATERIAL
K993717 · Davis Schottlander & Davis, Ltd. · Dec 1999
MODIFICATION TO LINER II: SOFT RELINE LIQUID
K991687 · Bosworth Co. · Oct 1999
LUCITONE FRS FLEXIBEL DENTAL RESIN
K992956 · Dentsply Intl. · Oct 1999