Cleared Traditional

K873818 - VENT CORP PIB IMPLANT

K873818 is an FDA 510(k) clearance for VENT CORP PIB IMPLANT, 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 162-day FDA review.

K873818 · Core-Vent Corp. · Dental device
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Feb 1988
Decision
162d
Days
Class 2
Risk

K873818 is an FDA 510(k) clearance for the VENT CORP PIB IMPLANT. 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 February 26, 1988 after a review of 162 days - an extended review 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: 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 Core-Vent Corp. devices

FDA 510(k) Submission Details - K873818

510(k) Number K873818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1987
Decision Date February 26, 1988
Days to Decision 162 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
35d slower than avg
Panel avg: 127d · This submission: 162d
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 K873818.
BIO-VENT
K883717 · Core-Vent Corp. · Sep 1989
IMZ O-RING ATTACHMENT
K883211 · Interpore Intl. · Nov 1988
THE MICRO-VENT/HA
K873255 · Core-Vent Corp. · Mar 1988
TITANODONT SUBCORTICAL IMPLANT WITH POROCOAT
K871219 · Depuy, Inc. · Jun 1987
MICRO-VENT
K864321 · Core-Vent Corp. · Jan 1987
SUB-VENT (TM) IMPLANT/ENDOSSEOUS BLADE IMPLANT
K861425 · Core-Vent Corp. · Nov 1986