Cleared Traditional

K872810 - STRUNG DENTAL ROLLS

K872810 is an FDA 510(k) clearance for STRUNG DENTAL ROLLS, manufactured by American Silk Sutures, Inc.. The device is a Class 1 Dental device with product code EFN cleared through the Traditional 510(k) pathway after a 143-day FDA review.

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

FDA 510(k) Submission Details - K872810

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.

EFN Device Classification - Class 1, General Controls

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.