Cleared Traditional

K922638 - TEMPIT-E

K922638 is the FDA 510(k) clearance for TEMPIT-E by Centrix, Inc.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K922638 · Centrix, Inc. · Dental device
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Aug 1992
Decision
97d
Days
Class 2
Risk

K922638 is an FDA 510(k) clearance for the TEMPIT-E. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on August 10, 1992 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 Centrix, Inc. devices

Submission Details

510(k) Number K922638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1992
Decision Date August 10, 1992
Days to Decision 97 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 127d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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.