Cleared Traditional

K950578 - SCREW-VENT IMPLANT

K950578 is an FDA 510(k) clearance for SCREW-VENT 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 165-day FDA review.

K950578 · Core-Vent Corp. · Dental device
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Jul 1995
Decision
165d
Days
Class 2
Risk

K950578 is an FDA 510(k) clearance for the SCREW-VENT IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Core-Vent Corp. (Las Vegas, US). The FDA issued a Cleared decision on July 11, 1995 after a review of 165 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 - K950578

510(k) Number K950578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1995
Decision Date July 11, 1995
Days to Decision 165 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 127d · This submission: 165d
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 K950578.
BIO-VENT IMPLANT
K950575 · Core-Vent Corp. · Jul 1995
BIO-VENT X IMPLANT
K950576 · Core-Vent Corp. · Jul 1995
SWEDE-VENT IMPLANT
K950577 · Core-Vent Corp. · Jul 1995
MICRO-VENT IMPLANT
K950579 · Core-Vent Corp. · Jul 1995
3I ASYST ABUTMENT PACKAGE SYSTEM
K951553 · Implant Innovations, Inc. · Jun 1995
STERI-OSS SELF TAPING IMPLANT
K952644 · Steri-Oss, Inc. · Jun 1995