Cleared Traditional

DENTAL X-RAY BITE BLOCK (K890355) - FDA 510(k) Clearance

Class I Dental device.

K890355 · Bite-A-Block · Dental device
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Jun 1989
Decision
139d
Days
Class 1
Risk

K890355 is an FDA 510(k) clearance for the DENTAL X-RAY BITE BLOCK. Classified as Holder, Film, X-ray (product code EGZ), Class I - General Controls.

Submitted by Bite-A-Block (Daly City, US). The FDA issued a Cleared decision on June 12, 1989 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.1905 - 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 Bite-A-Block devices

Submission Details

510(k) Number K890355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1989
Decision Date June 12, 1989
Days to Decision 139 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 127d · This submission: 139d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EGZ Holder, Film, X-ray
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.1905
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.