Cleared Traditional

TIN COATED DENTAL BURS (K911208) - FDA 510(k) Clearance

Class I Dental device.

K911208 · Surgical Precision Instruments, Corp. · Dental device
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Sep 1991
Decision
181d
Days
Class 1
Risk

K911208 is an FDA 510(k) clearance for the TIN COATED DENTAL BURS. Classified as Bur, Dental (product code EJL), Class I - General Controls.

Submitted by Surgical Precision Instruments, Corp. (Barrington, US). The FDA issued a Cleared decision on September 16, 1991 after a review of 181 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3240 - 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 Surgical Precision Instruments, Corp. devices

Submission Details

510(k) Number K911208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1991
Decision Date September 16, 1991
Days to Decision 181 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 127d · This submission: 181d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EJL Bur, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3240
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.