Cleared Traditional

K931093 - QUICK-CONNECT 360 SWIVEL TIP AUTOCLAVABLE SYRINGE

K931093 is an FDA 510(k) clearance for QUICK-CONNECT 360 SWIVEL TIP AUTOCLAVAB..., manufactured by Dentalez Group. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 324-day FDA review.

K931093 · Dentalez Group · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
324d
Days
Class 1
Risk

K931093 is an FDA 510(k) clearance for the QUICK-CONNECT 360 SWIVEL TIP AUTOCLAVABLE SYRINGE. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Dentalez Group (Lancaster, US). The FDA issued a Cleared decision on January 21, 1994 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K931093

510(k) Number K931093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1993
Decision Date January 21, 1994
Days to Decision 324 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
196d slower than avg
Panel avg: 128d · This submission: 324d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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.

Regulatory Peers - EIA Unit, Operative Dental

All 261
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K931093.
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ACE DENTAL IMPLANT KIT
K922651 · Ace Surgical Supply Co., Inc. · Jan 1994
K931093 · QUICK-CONNECT 360 SWIVEL TIP AUTOCLAVABLE SYRINGE
Download PDF FDA Summary Dentalez Group