Cleared Traditional

K900177 - CORE-VENT ARMENTARIUM

K900177 is an FDA 510(k) clearance for CORE-VENT ARMENTARIUM, 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 163-day FDA review.

K900177 · Core-Vent Corp. · Dental device
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Jun 1990
Decision
163d
Days
Class 2
Risk

K900177 is an FDA 510(k) clearance for the CORE-VENT ARMENTARIUM. 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 June 28, 1990 after a review of 163 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 - K900177

510(k) Number K900177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1990
Decision Date June 28, 1990
Days to Decision 163 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
36d slower than avg
Panel avg: 127d · This submission: 163d
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 K900177.
SWEDE-VENT ENDOSSEOUS IMPLANT ABUTMENTS
K900182 · Core-Vent Corp. · Nov 1990
SWEDE-VENT ENDOSSEOUS HA COATED DENTAL IMPLANTS
K900634 · Core-Vent Corp. · Nov 1990
INTERPORE IMZ SINGLE TOOTH ATTACHMENT SYSTEM
K900793 · Interpore Intl. · Jul 1990
BONEFIT HOLLOW CYLINDER IMPLANTS
K894593 · Institut Straumann AG · Feb 1990
BONEFIT HOLLOW SCREW IMPLANTS
K894594 · Institut Straumann AG · Feb 1990
BONEFIT R SCREW IMPLANTS
K894595 · Institut Straumann AG · Feb 1990