Cleared Traditional

K832286 - CERESTORE CORE MATERIAL

K832286 is the FDA 510(k) clearance for CERESTORE CORE MATERIAL by Johnson & Johnson Professionals, Inc.. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K832286 · Johnson & Johnson Professionals, Inc. · Dental device
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Sep 1983
Decision
75d
Days
Class 2
Risk

K832286 is an FDA 510(k) clearance for the CERESTORE CORE MATERIAL. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on September 26, 1983 after a review of 75 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 K832286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1983
Decision Date September 26, 1983
Days to Decision 75 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
52d faster than avg
Panel avg: 127d · This submission: 75d
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 278
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K832286.
CRYSTAR PORCELAIN MARGIN POWDER/LIQUID
K840873 · Shofu Dental Corp. · Apr 1984
SHOFU PORCELAIN STAIN
K834497 · Shofu Dental Corp. · Mar 1984
CRYSTAR PORCELAIN
K833643 · Shofu Dental Corp. · Dec 1983
DENTAL CERAMIC FOR FABRICATION OF CROWN
K830955 · Dentsply Intl. · May 1983
DENTAL PORCELAIN POWDER
K830553 · Dentsply Intl. · Apr 1983
PORCELAIN POWDER FOR CLINICAL USE
K810096 · Dentsply Intl. · Mar 1981