Cleared Traditional

K911214 - NUTIP (TM) SYRINGE SHIELD

K911214 is an FDA 510(k) clearance for NUTIP (TM) SYRINGE SHIELD, manufactured by Western M/D, Inc.. The device is a Class 1 Dental device with product code EKJ cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K911214 · Western M/D, Inc. · Dental device
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Jul 1991
Decision
120d
Days
Class 1
Risk

K911214 is an FDA 510(k) clearance for the NUTIP (TM) SYRINGE SHIELD. Classified as Burnisher, Operative (product code EKJ), Class I - General Controls.

Submitted by Western M/D, Inc. (Burlingame, US). The FDA issued a Cleared decision on July 17, 1991 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 Western M/D, Inc. devices

FDA 510(k) Submission Details - K911214

510(k) Number K911214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1991
Decision Date July 17, 1991
Days to Decision 120 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 127d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

EKJ Device Classification - Class 1, General Controls

Product Code EKJ Burnisher, Operative
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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 - EKJ Burnisher, Operative

All 23
Devices cleared under the same product code (EKJ) and FDA review panel - the closest regulatory comparables to K911214.
APPLICATOR NOZZLE
K926368 · Centrix, Inc. · Sep 1993
PART 872 DEGUFILL H & DEGUFILL M DA
K914368 · Degussa AG · Nov 1991
IMPLARETTE
K911655 · Implant Innovations International, Inc. · Oct 1991
HARDCOATED PLASTIC FILLING INSTRUMENT
K912149 · Premier Dental Products Co. · Jun 1991
PULPDENT PIC N STIC
K911281 · Pulpdent Corp. · May 1991
MIRROR SHIELD
K901053 · Pulpdent Corp. · May 1990