Cleared Traditional

K912632 - OCCLUDE

K912632 is an FDA 510(k) clearance for OCCLUDE, manufactured by Pascal Co., Inc.. The device is a Class 1 Dental device with product code EFH cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K912632 · Pascal Co., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
217d
Days
Class 1
Risk

K912632 is an FDA 510(k) clearance for the OCCLUDE. Classified as Paper, Articulation (product code EFH), Class I - General Controls.

Submitted by Pascal Co., Inc. (Bellevue, US). The FDA issued a Cleared decision on January 17, 1992 after a review of 217 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6140 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Pascal Co., Inc. devices

FDA 510(k) Submission Details - K912632

510(k) Number K912632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1991
Decision Date January 17, 1992
Days to Decision 217 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 127d · This submission: 217d
Pathway characteristics
Predicate-based equivalence.

EFH Device Classification - Class 1, General Controls

Product Code EFH Paper, Articulation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6140
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.