Cleared Traditional

K894759 - ALLPAC(TM) MATERIAL

K894759 is an FDA 510(k) clearance for ALLPAC(TM) MATERIAL, manufactured by Barrier Concepts, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K894759 · Barrier Concepts, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1989
Decision
78d
Days
Class 1
Risk

K894759 is an FDA 510(k) clearance for the ALLPAC(TM) MATERIAL. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Barrier Concepts, Inc. (Columbia, US). The FDA issued a Cleared decision on October 13, 1989 after a review of 78 days - a notably fast clearance cycle.

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: 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 Barrier Concepts, Inc. devices

FDA 510(k) Submission Details - K894759

510(k) Number K894759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1989
Decision Date October 13, 1989
Days to Decision 78 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 127d · This submission: 78d
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 193
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K894759.
A-DEC IC MICRO-CART
K903453 · A-Dec, Inc. · Oct 1990
A-DEC DECADE CUSPIDOR
K903455 · A-Dec, Inc. · Oct 1990
SUCTION ORA-SWAB(R) BRUSH KIT
K901806 · Sage Products, Inc. · Aug 1990
DELIVERY PUMP FOR STERILE IRRIGANT & HANDPIECE DR.
K882526 · Aseptico, Inc. · Dec 1988
CM-II, CM-I WATER UNIT
K863021 · Sds Dental, Inc. · Oct 1986
EUROCART SR-4, EUROCART M-IV, ISOCART III
K863010 · Sds Dental, Inc. · Sep 1986