Cleared Traditional

K854494 - CERAM-ETCH

K854494 is an FDA 510(k) clearance for CERAM-ETCH, manufactured by Gresco Products, Inc.. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K854494 · Gresco Products, Inc. · Dental device
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Dec 1985
Decision
41d
Days
Class 2
Risk

K854494 is an FDA 510(k) clearance for the CERAM-ETCH. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Gresco Products, Inc. (Stafford, US). The FDA issued a Cleared decision on December 23, 1985 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3765 - 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 Gresco Products, Inc. devices

FDA 510(k) Submission Details - K854494

510(k) Number K854494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1985
Decision Date December 23, 1985
Days to Decision 41 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 127d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBC Device Classification - Class 2, Special Controls

Product Code EBC Sealant, Pit And Fissure, And Conditioner
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3765
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 - EBC Sealant, Pit And Fissure, And Conditioner

All 102
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K854494.
PRISMA METAL OPAQUERS
K862660 · Dentsply Intl. · Jul 1986
SEALITE
K862284 · Sybron Corp. · Jun 1986
PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT
K854882 · Lee Pharmaceuticals · Jan 1986
PIT AND FISSURE SEAANTS
K844308 · Dentsply Intl. · Jan 1985
CONCISE LIGHT CURED WHITE SEALANT
K844211 · 3M Company · Jan 1985
COMMAND ULTRASEAL PIT & FISSURE SEALANT
K843024 · Kerr Corporation (Danbury) · Sep 1984