Cleared Traditional

K050318 - BARI-KAD PACKING DEVICE

K050318 is an FDA 510(k) clearance for BARI-KAD PACKING DEVICE, manufactured by Bioenvelop Agro, Inc.. The device is a Class 1 Dental device with product code EIE cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K050318 · Bioenvelop Agro, Inc. · Dental device
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Mar 2005
Decision
23d
Days
Class 1
Risk

K050318 is an FDA 510(k) clearance for the BARI-KAD PACKING DEVICE. Classified as Dam, Rubber (product code EIE), Class I - General Controls.

Submitted by Bioenvelop Agro, Inc. (West Cadwell, US). The FDA issued a Cleared decision on March 4, 2005 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6300 - 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 Bioenvelop Agro, Inc. devices

FDA 510(k) Submission Details - K050318

510(k) Number K050318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2005
Decision Date March 04, 2005
Days to Decision 23 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
104d faster than avg
Panel avg: 127d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

EIE Device Classification - Class 1, General Controls

Product Code EIE Dam, Rubber
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6300
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 - EIE Dam, Rubber

All 12
Devices cleared under the same product code (EIE) and FDA review panel - the closest regulatory comparables to K050318.
armor LC
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