Cleared Traditional

K933507 - NEEDLETUBE SYRINGE CARTRTIDGE

K933507 is the FDA 510(k) clearance for NEEDLETUBE SYRINGE CARTRTIDGE by Centrix, Inc.. It is a Class 2 Dental device (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

Submission Details

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.

Device Classification

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 41
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