Cleared Traditional

STRUNG DENTAL ROLLS (K872810) - FDA 510(k) Clearance

Class I Dental device.

K872810 · American Silk Sutures, Inc. · Dental device
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Dec 1987
Decision
143d
Days
Class 1
Risk

K872810 is an FDA 510(k) clearance for the STRUNG DENTAL ROLLS. Classified as Cotton, Roll (product code EFN), Class I - General Controls.

Submitted by American Silk Sutures, Inc. (Lynn, US). The FDA issued a Cleared decision on December 4, 1987 after a review of 143 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 American Silk Sutures, Inc. devices

Submission Details

510(k) Number K872810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1987
Decision Date December 04, 1987
Days to Decision 143 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 127d · This submission: 143d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFN Cotton, Roll
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.