Cleared Traditional

NIC TONE ACRYLIC RESINS (K991577) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K991577 · Manufacturera Dental Continental · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

Device Classification

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 79
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K991577.
MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM
K032892 · Dentsply Intl. · Sep 2003
TRUBYTE DENTURE BASE RESIN SYSTEM
K011560 · Dentsply Intl. · Jul 2001
LUCITONE FRS FLEXIBEL DENTAL RESIN
K992956 · Dentsply Intl. · Oct 1999
LIQCRYLIC PRO DENTAL RESIN
K972573 · Dentsply Intl. · Sep 1997
TRUBYTE SOFT RELINE SYSTEM
K964040 · Dentsply Intl. · Dec 1996
PRECISE DENTURE BASE RESIN
K952351 · Dentsply Intl. · Jul 1995