Cleared Traditional

K941431 - BONE GRAFT DELIVERY SYRINGES

K941431 is an FDA 510(k) clearance for BONE GRAFT DELIVERY SYRINGES, manufactured by Bio-Interfaces, Inc.. The device is a Class 1 Dental device with product code EID cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K941431 · Bio-Interfaces, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
110d
Days
Class 1
Risk

K941431 is an FDA 510(k) clearance for the BONE GRAFT DELIVERY SYRINGES. Classified as Syringe, Restorative And Impression Material (product code EID), Class I - General Controls.

Submitted by Bio-Interfaces, Inc. (San Diego, US). The FDA issued a Cleared decision on July 12, 1994 after a review of 110 days - within the typical 510(k) review window.

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: 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 Bio-Interfaces, Inc. devices

FDA 510(k) Submission Details - K941431

510(k) Number K941431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1994
Decision Date July 12, 1994
Days to Decision 110 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
17d faster than avg
Panel avg: 127d · This submission: 110d
Pathway characteristics
Predicate-based equivalence.

EID Device Classification - Class 1, General Controls

Product Code EID Syringe, Restorative And Impression Material
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.

Regulatory Peers - EID Syringe, Restorative And Impression Material

All 10
Devices cleared under the same product code (EID) and FDA review panel - the closest regulatory comparables to K941431.
ACCESS IMPRESSION BARREL
K913974 · Centrix, Inc. · Feb 1992
CAULK'S VPS CARTRIDGE SYSTEM
K873153 · Dentsply Intl. · Sep 1987
IMPRESSION SYRINGE
K871937 · Dentsply Intl. · Jun 1987
CENTRIX RIBBON TUBES
K853282 · Centrix, Inc. · Aug 1985
UNITEK DISPOSABLE IMPRESSION SYRINGE
K851386 · Unitek Corp. · Apr 1985
G-C IMPRESSION SYRINGE
K812680 · G-C Intl. Corp. · Oct 1981