Cleared Traditional

K891698 - ZAROLAN, DUALAN, TITAN AND SUPERON

K891698 is an FDA 510(k) clearance for ZAROLAN, manufactured by Dent Zar, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K891698 · Dent Zar, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1989
Decision
81d
Days
Class 2
Risk

K891698 is an FDA 510(k) clearance for the ZAROLAN, DUALAN, TITAN AND SUPERON. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Dent Zar, Inc. (Los Angeles, US). The FDA issued a Cleared decision on June 9, 1989 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Dent Zar, Inc. devices

FDA 510(k) Submission Details - K891698

510(k) Number K891698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1989
Decision Date June 09, 1989
Days to Decision 81 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 127d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 762
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K891698.
CROWN AND BRIDGE DENTAL RESTORATIVE COMPOSITE SYST
K894644 · Jeneric/Pentron, Inc. · Oct 1989
KULZER ADHESIVE CEMENT
K892455 · Kulzer, Inc. · Jun 1989
KULZER INLAY SYSTEM
K892454 · Kulzer, Inc. · Jun 1989
ESPE TULUX-CEM
K891020 · Espe GmbH (Us) · May 1989
ADHERENCE M5 MULTI-CURE COMPOSITE CEMENT SYSTEM
K891463 · Confi-Dental Products Co. · May 1989
CLEARFIL CR INLAY
K890123 · Kuraray Co. · Mar 1989