Cleared Traditional

INTERPORE 200 POROUS HYDROXYAPATITE (K852975) - FDA 510(k) Clearance

Class I Dental device.

K852975 · Inrterpore Intl. · Dental device
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Oct 1985
Decision
108d
Days
Class 1
Risk

K852975 is an FDA 510(k) clearance for the INTERPORE 200 POROUS HYDROXYAPATITE. Classified as Wire, Orthodontic (product code DZC), Class I - General Controls.

Submitted by Inrterpore Intl. (Irvine, US). The FDA issued a Cleared decision on October 31, 1985 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5410 - 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 Inrterpore Intl. devices

Submission Details

510(k) Number K852975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1985
Decision Date October 31, 1985
Days to Decision 108 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 127d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DZC Wire, Orthodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.5410
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.