Cleared Traditional

K992956 - LUCITONE FRS FLEXIBEL DENTAL RESIN

K992956 is an FDA 510(k) clearance for LUCITONE FRS FLEXIBEL DENTAL RESIN, manufactured by Dentsply Intl.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K992956 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
34d
Days
Class 2
Risk

K992956 is an FDA 510(k) clearance for the LUCITONE FRS FLEXIBEL DENTAL RESIN. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on October 6, 1999 after a review of 34 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 Dentsply Intl. devices

FDA 510(k) Submission Details - K992956

510(k) Number K992956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1999
Decision Date October 06, 1999
Days to Decision 34 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 127d · This submission: 34d
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 259
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K992956.
UFI GEL HARD
K993827 · Voco GmbH · Jan 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
NIC TONE ACRYLIC RESINS
K991577 · Manufacturera Dental Continental · Sep 1999
HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400
K992609 · Kay See Dental Mfg. Co. · Sep 1999
IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR
K991996 · Denplus, Inc. · Sep 1999