Cleared Traditional

K933507 - NEEDLETUBE SYRINGE CARTRTIDGE

K933507 is an FDA 510(k) clearance for NEEDLETUBE SYRINGE CARTRTIDGE, manufactured by Centrix, Inc.. The device is a Class 2 Dental device with product code EJK cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K933507 · Centrix, Inc. · Dental device
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Jan 1994
Decision
187d
Days
Class 2
Risk

K933507 is an FDA 510(k) clearance for the NEEDLETUBE SYRINGE CARTRTIDGE. Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on January 18, 1994 after a review of 187 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3250 - 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 Centrix, Inc. devices

FDA 510(k) Submission Details - K933507

510(k) Number K933507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1993
Decision Date January 18, 1994
Days to Decision 187 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 127d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJK Device Classification - Class 2, Special Controls

Product Code EJK Liner, Cavity, Calcium Hydroxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EJK Liner, Cavity, Calcium Hydroxide

All 60
Devices cleared under the same product code (EJK) and FDA review panel - the closest regulatory comparables to K933507.
PULPDENT CALCIUM HYDROXIDE PREPARATIONS
K944945 · Pulpdent Corp. · Nov 1994
LIFE
K944416 · Sybron Dental Specialties, Inc. · Nov 1994
CALCIUM HYDROXIDE PASTE
K943372 · Ultradent Products, Inc. · Sep 1994
STERIBASE (ACCUBASE)
K933999 · Centrix, Inc. · Jan 1994
VIVAGLASS LINER
K931502 · Ivoclar North America, Inc. · Jul 1993
CALCICUR
K926419 · Voco GmbH · Mar 1993