Cleared Traditional

K991577 - NIC TONE ACRYLIC RESINS

K991577 is an FDA 510(k) clearance for NIC TONE ACRYLIC RESINS, manufactured by Manufacturera Dental Continental. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K991577 · Manufacturera Dental Continental · Dental device
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Sep 1999
Decision
139d
Days
Class 2
Risk

K991577 is an FDA 510(k) clearance for the NIC TONE ACRYLIC RESINS. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Manufacturera Dental Continental (Haguna Nyvel, US). The FDA issued a Cleared decision on September 22, 1999 after a review of 139 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Manufacturera Dental Continental devices

FDA 510(k) Submission Details - K991577

510(k) Number K991577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1999
Decision Date September 22, 1999
Days to Decision 139 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
12d slower than avg
Panel avg: 127d · This submission: 139d
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 K991577.
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
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
ACRON MC MODIFICATION
K991774 · GC America, Inc. · Jul 1999