Cleared Traditional

K834361 - JSB JET SYRINGE

K834361 is an FDA 510(k) clearance for JSB JET SYRINGE, manufactured by C.B.S. Biotechnics, Inc.. The device is a Class 2 Dental device with product code EGM cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K834361 · C.B.S. Biotechnics, Inc. · Dental device
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Mar 1984
Decision
130d
Days
Class 2
Risk

K834361 is an FDA 510(k) clearance for the JSB JET SYRINGE. Classified as Injector, Jet, Mechanical-powered (product code EGM), Class II - Special Controls.

Submitted by C.B.S. Biotechnics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 5, 1984 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4475 - 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 C.B.S. Biotechnics, Inc. devices

FDA 510(k) Submission Details - K834361

510(k) Number K834361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1983
Decision Date March 05, 1984
Days to Decision 130 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 128d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EGM Device Classification - Class 2, Special Controls

Product Code EGM Injector, Jet, Mechanical-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4475
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.