Cleared Traditional

UNI-SYRINGE, UNI-TIP AND ACCESS SYRINGE TIPS (K942519) - FDA 510(k) Clearance

Class I Dental device.

K942519 · Bull Frog Mfg. Co. · Dental device
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Aug 1994
Decision
89d
Days
Class 1
Risk

K942519 is an FDA 510(k) clearance for the UNI-SYRINGE, UNI-TIP AND ACCESS SYRINGE TIPS. Classified as Unit, Syringe, Air And/or Water (product code ECB), Class I - General Controls.

Submitted by Bull Frog Mfg. Co. (Portland, US). The FDA issued a Cleared decision on August 23, 1994 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bull Frog Mfg. Co. devices

Submission Details

510(k) Number K942519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1994
Decision Date August 23, 1994
Days to Decision 89 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
38d faster than avg
Panel avg: 127d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ECB Unit, Syringe, Air And/or Water
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.