Cleared Traditional

CERESTORE DENTIN PORCELAIN (K850821) - FDA 510(k) Clearance

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

K850821 · Johnson & Johnson Professionals, Inc. · Dental device
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Apr 1985
Decision
39d
Days
Class 2
Risk

K850821 is an FDA 510(k) clearance for the CERESTORE DENTIN PORCELAIN. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (East Windsor, US). The FDA issued a Cleared decision on April 8, 1985 after a review of 39 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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K850821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1985
Decision Date April 08, 1985
Days to Decision 39 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
88d faster than avg
Panel avg: 127d · This submission: 39d
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 166
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K850821.
OPAQUE PORCELAIN
K900393 · Dentsply Intl. · Apr 1990
DICOR CASTABLE CERAMIC-ALL PORCELAIN BRIDGES
K853707 · Dentsply Intl. · Nov 1985
SCOTCHPRIME CERAMIC PRIMER
K853698 · 3M Company · Nov 1985
CERESTORE CORE MATERIAL
K832286 · Johnson & Johnson Professionals, Inc. · Sep 1983
DENTAL CERAMIC FOR FABRICATION OF CROWN
K830955 · Dentsply Intl. · May 1983
DENTAL PORCELAIN POWDER
K830553 · Dentsply Intl. · Apr 1983