Cleared Traditional

K870383 - ALGINATE WOOL FIBER

K870383 is an FDA 510(k) clearance for ALGINATE WOOL FIBER, manufactured by Adri. The device is a Class 1 Dental device with product code KHR cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K870383 · Adri · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1987
Decision
90d
Days
Class 1
Risk

K870383 is an FDA 510(k) clearance for the ALGINATE WOOL FIBER. Classified as Absorber, Saliva, Paper (product code KHR), Class I - General Controls.

Submitted by Adri (Park Forest, US). The FDA issued a Cleared decision on April 30, 1987 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6050 - 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 Adri devices

FDA 510(k) Submission Details - K870383

510(k) Number K870383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1987
Decision Date April 30, 1987
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

KHR Device Classification - Class 1, General Controls

Product Code KHR Absorber, Saliva, Paper
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6050
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.