Cleared Traditional

K864321 - MICRO-VENT

K864321 is an FDA 510(k) clearance for MICRO-VENT, manufactured by Core-Vent Corp.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K864321 · Core-Vent Corp. · Dental device
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Jan 1987
Decision
65d
Days
Class 2
Risk

K864321 is an FDA 510(k) clearance for the MICRO-VENT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Core-Vent Corp. (Encino, US). The FDA issued a Cleared decision on January 7, 1987 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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 Core-Vent Corp. devices

FDA 510(k) Submission Details - K864321

510(k) Number K864321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1986
Decision Date January 07, 1987
Days to Decision 65 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 127d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 758
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K864321.
THE MICRO-VENT/HA
K873255 · Core-Vent Corp. · Mar 1988
VENT CORP PIB IMPLANT
K873818 · Core-Vent Corp. · Feb 1988
TITANODONT SUBCORTICAL IMPLANT WITH POROCOAT
K871219 · Depuy, Inc. · Jun 1987
SUB-VENT (TM) IMPLANT/ENDOSSEOUS BLADE IMPLANT
K861425 · Core-Vent Corp. · Nov 1986
IMZ INTRAMOBILE CYLINDER IMPLANT SYSTEM COMPONENTS
K863680 · Interpore Intl. · Oct 1986
SCREW-VENT (TM) IMPLANT/ENDOSSEOUS SCREW IMPLANT
K861426 · Core-Vent Corp. · Oct 1986