Cleared Traditional

K113753 - ZIMMER DENTAL TAPERED SCREW-VENT X

K113753 is the FDA 510(k) clearance for ZIMMER DENTAL TAPERED SCREW-VENT X by Zimmer Dental, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K113753 · Zimmer Dental, Inc. · Dental device
Download Printable Device Report (PDF)
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Aug 2012
Decision
253d
Days
Class 2
Risk

K113753 is an FDA 510(k) clearance for the ZIMMER DENTAL TAPERED SCREW-VENT X. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Zimmer Dental, Inc. (Carlsbad, US). The FDA issued a Cleared decision on August 30, 2012 after a review of 253 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 Zimmer Dental, Inc. devices

Submission Details

510(k) Number K113753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2011
Decision Date August 30, 2012
Days to Decision 253 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 127d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 581
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K113753.
TS FIXTURE SYSTEM
K121995 · Osstem Implant Co., Ltd. · Nov 2012
MS SA IMPLANT SYSTEM
K122171 · Osstem Implant Co., Ltd. · Nov 2012
BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS
K121787 · BioHorizons Implant Systems, Inc. · Sep 2012
ET/SS IMPLANT SYSTEM
K120847 · Osstem Implant Co., Ltd. · Aug 2012
BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM
K121131 · Straumann USA · Jun 2012
HAPTITE COATING IMPLANT SYSTEM
K111364 · Dentis Co., Ltd. · Feb 2012