Cleared Traditional

K833725 - PRE-LOADED C-R TUBES FOR SYRINGE

K833725 is an FDA 510(k) clearance for PRE-LOADED C-R TUBES FOR SYRINGE, manufactured by Centrix, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K833725 · Centrix, Inc. · Dental device
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Mar 1984
Decision
158d
Days
Class 2
Risk

K833725 is an FDA 510(k) clearance for the PRE-LOADED C-R TUBES FOR SYRINGE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Centrix, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 30, 1984 after a review of 158 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 - K833725

510(k) Number K833725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1983
Decision Date March 30, 1984
Days to Decision 158 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 127d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 784
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K833725.
JOHNSON & JOHNSON POSTERIOR DENTAL (ADAPTIC II)
K841518 · Johnson & Johnson Professionals, Inc. · May 1984
LIGHT CURED RESIN BONDED CERAMIC
K833797 · 3M Company · Apr 1984
ESTIC MICROFILL
K840176 · Kulzer, Inc. · Apr 1984
REMBRANDT SHADE MODIFICATION KIT
K841111 · Den-Mat Corp. · Mar 1984
CURAY-MATCH PAINT-ON COMPOSITE RESTOR
K833810 · Scientific Pharmaceuticals, Inc. · Feb 1984
MATERIAL TOOTHSADE RESIN
K834247 · Scientific Pharmaceuticals, Inc. · Feb 1984