Cleared Traditional

K781787 - ISOPLAST

K781787 is the FDA 510(k) clearance for ISOPLAST by Vivadent (Usa), Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K781787 · Vivadent (Usa), Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1978
Decision
62d
Days
Class 2
Risk

K781787 is an FDA 510(k) clearance for the ISOPLAST. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Vivadent (Usa), Inc. (Mchenry, US). The FDA issued a Cleared decision on December 20, 1978 after a review of 62 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 Vivadent (Usa), Inc. devices

Submission Details

510(k) Number K781787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1978
Decision Date December 20, 1978
Days to Decision 62 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 127d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 604
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K781787.
ANTERIOR/POSTERIOR RESTORATIVE LIQUID
K790822 · Scientific Pharmaceuticals, Inc. · Jul 1979
PAINT-ON RESTORATIVE, LIGHT CURED
K790963 · Scientific Pharmaceuticals, Inc. · Jul 1979
DENTAL COMPOSITE RESTORATIVE MATERIAL
K790594 · Wallace A. Erickson & Co. · Jun 1979
AUROFIL
K781687 · Wallace A. Erickson & Co. · Dec 1978
ZYTRON
K780796 · Premier Dental Products Co. · Jun 1978
NEW RESTODENT
K780965 · Lee Pharmaceuticals · Jun 1978