Cleared Traditional

PRESTYL JET INJECTOR (K922683) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K922683 · Bma Technologies S.A. · Dental device
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Apr 1994
Decision
676d
Days
Class 2
Risk

K922683 is an FDA 510(k) clearance for the PRESTYL JET INJECTOR. Classified as Syringe, Cartridge (product code EJI), Class II - Special Controls.

Submitted by Bma Technologies S.A. (Washington, US). The FDA issued a Cleared decision on April 11, 1994 after a review of 676 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6770 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Bma Technologies S.A. devices

Submission Details

510(k) Number K922683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1992
Decision Date April 11, 1994
Days to Decision 676 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
549d slower than avg
Panel avg: 127d · This submission: 676d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJI Syringe, Cartridge
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6770
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.