Cleared Traditional

K853698 - SCOTCHPRIME CERAMIC PRIMER

K853698 is the FDA 510(k) clearance for SCOTCHPRIME CERAMIC PRIMER by 3M Company. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K853698 · 3M Company · Dental device
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Nov 1985
Decision
71d
Days
Class 2
Risk

K853698 is an FDA 510(k) clearance for the SCOTCHPRIME CERAMIC PRIMER. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by 3M Company (Cottae Grove, US). The FDA issued a Cleared decision on November 14, 1985 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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 3M Company devices

Submission Details

510(k) Number K853698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1985
Decision Date November 14, 1985
Days to Decision 71 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 127d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 260
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K853698.
PV-CERAMIC, CERAMINIQUE
K901261 · Ivoclar North America, Inc. · Jun 1990
OPAQUE PORCELAIN
K900393 · Dentsply Intl. · Apr 1990
DICOR CASTABLE CERAMIC-ALL PORCELAIN BRIDGES
K853707 · Dentsply Intl. · Nov 1985
CERESTORE DENTIN PORCELAIN
K850821 · Johnson & Johnson Professionals, Inc. · Apr 1985
CRYSTAR PORCELAIN MARGIN POWDER/LIQUID
K840873 · Shofu Dental Corp. · Apr 1984
SHOFU PORCELAIN STAIN
K834497 · Shofu Dental Corp. · Mar 1984