Cleared Traditional

K991996 - IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR

K991996 is an FDA 510(k) clearance for IMPACT-PLUS, manufactured by Denplus, Inc.. 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.

K991996 · Denplus, Inc. · Dental device
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Sep 1999
Decision
86d
Days
Class 2
Risk

K991996 is an FDA 510(k) clearance for the IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Denplus, Inc. (Montreal, Quebec, CA). The FDA issued a Cleared decision on September 8, 1999 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 Denplus, Inc. devices

FDA 510(k) Submission Details - K991996

510(k) Number K991996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1999
Decision Date September 08, 1999
Days to Decision 86 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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 214
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K991996.
LUCITONE FRS FLEXIBEL DENTAL RESIN
K992956 · Dentsply Intl. · 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
ACRON MC MODIFICATION
K991774 · GC America, Inc. · Jul 1999
GC RELINE SOFT/EXTRA SOFT
K990736 · GC America, Inc. · May 1999
VITRON M
K990763 · Espe Dental AG · May 1999