Cleared Traditional

K953101 - PARAGON IMPLANT SYSTEM

K953101 is an FDA 510(k) clearance for PARAGON IMPLANT SYSTEM, manufactured by Core-Vent Bio-Engineering, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K953101 · Core-Vent Bio-Engineering, Inc. · Dental device
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Dec 1995
Decision
171d
Days
Class 2
Risk

K953101 is an FDA 510(k) clearance for the PARAGON IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Core-Vent Bio-Engineering, Inc. (Calabasas, US). The FDA issued a Cleared decision on December 21, 1995 after a review of 171 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 Bio-Engineering, Inc. devices

FDA 510(k) Submission Details - K953101

510(k) Number K953101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1995
Decision Date December 21, 1995
Days to Decision 171 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
44d slower than avg
Panel avg: 127d · This submission: 171d
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 1314
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K953101.
RESTORE HA DENTAL IMPLANT SYSTEM
K954865 · Lifecore Biomedical, Inc. · Jan 1996
KIS MED THREAD IMPLANT & PROSTHESIS SYSTEM
K955048 · The Implant Center of the Palm Beaches · Jan 1996
CAL-FORM DENTAL IMPLANTS
K933646 · Cal-Form, Inc. · Jan 1996
INTEGRAL VII 4.9MM BIOINTEGRATED DENTAL IMPLANT SYSTEM
K946319 · Calcitek, Inc. · Nov 1995
INTEGRAL VIII BIOINTEGRATED DENTAL IMPLANT SYSTEM
K946345 · Calcitek, Inc. · Nov 1995
WIDE SCREWS TP-5B. PROS G5, TOOLS G5 OR 17-4 SS
K952985 · Implant Center of the Palm Beaches · Oct 1995