Cleared Traditional

STRUNG DENTAL ROLLS

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

About This 510(k) Submission

K872810 is an FDA 510(k) clearance for the STRUNG DENTAL ROLLS, a Cotton, Roll (Class I — General Controls, product code EFN), submitted by American Silk Sutures, Inc. (Lynn, US). The FDA issued a Cleared decision on December 4, 1987, 143 days after receiving the submission on July 14, 1987. This device falls under the Dental review panel. Regulated under 21 CFR 872.6050.

Submission Details

510(k) Number K872810 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 1987
Decision Date December 04, 1987
Days to Decision 143 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EFN — Cotton, Roll
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6050

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