Cleared Traditional

K012473 - VIDENT HEXTOP, SYNOCTA IN-CERAM BLANK/COPING MANUFACTURED BY VIDENT

K012473 is an FDA 510(k) clearance for VIDENT HEXTOP, manufactured by Vident. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 405-day FDA review.

K012473 · Vident · Dental device
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Sep 2002
Decision
405d
Days
Class 2
Risk

K012473 is an FDA 510(k) clearance for the VIDENT HEXTOP, SYNOCTA IN-CERAM BLANK/COPING MANUFACTURED BY VIDENT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Vident (Brea, US). The FDA issued a Cleared decision on September 11, 2002 after a review of 405 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

FDA 510(k) Submission Details - K012473

510(k) Number K012473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2001
Decision Date September 11, 2002
Days to Decision 405 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
277d slower than avg
Panel avg: 128d · This submission: 405d
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 1547
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K012473.
POST AND CORE - THIN FOR THE BASIC DENTAL IMPLANT SYSTEM
K022912 · Basic Dental Implant Systems, Inc. · Sep 2002
3I DENTAL IMPLANT ACCESSORIES
K022113 · Implant Innovations, Inc. · Sep 2002
ABUTMENT AND PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM
K022859 · Straumann USA · Sep 2002
ENDOSSEOUS IMPLANT
K021355 · Branemark Integration AB · Aug 2002
3A DENTAL IMPLANT SYSTEM
K011879 · Osseco Biosource, Ltd. · Aug 2002
SCREWLINE
K022425 · Altatec Biotechnologies N.A., Inc. · Aug 2002
K012473 · VIDENT HEXTOP, SYNOCTA IN-CERAM BLANK/COPING MANUFACTURED BY VIDENT
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