Cleared Traditional

K911208 - TIN COATED DENTAL BURS

K911208 is an FDA 510(k) clearance for TIN COATED DENTAL BURS, manufactured by Surgical Precision Instruments, Corp.. The device is a Class 1 Dental device with product code EJL cleared through the Traditional 510(k) pathway after a 181-day FDA review.

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

FDA 510(k) Submission Details - K911208

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.

EJL Device Classification - Class 1, General Controls

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.

Regulatory Peers - EJL Bur, Dental

All 8
Devices cleared under the same product code (EJL) and FDA review panel - the closest regulatory comparables to K911208.
SMARTBURS
K080687 · S.S. White Burs, Inc. · Jun 2008
CERADRILL
K071352 · Gebr. Brasseler GmbH & Co. KG · Jun 2007
BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS
K061383 · B.T.I. Biotechnology Institute, Sl. · Aug 2006
DIAMONDS BURS-COMPOSIT FINISHING
K854690 · Almore Intl., Inc. · Mar 1986
DIAMOND BURS-HANDPIECE
K854691 · Almore Intl., Inc. · Mar 1986
DENTAL INSTRUMENTS
K823314 · Miltex, Inc. · Nov 1982