Cleared Traditional

K133255 - ZERAMEX T AND ZERAMEX PLUS DENTAL IMPLANT SYSTEMS

K133255 is an FDA 510(k) clearance for ZERAMEX T AND ZERAMEX PLUS DENTAL IMPLA..., manufactured by Dentalpoint AG. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 293-day FDA review.

K133255 · Dentalpoint AG · Dental device
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Aug 2014
Decision
293d
Days
Class 2
Risk

K133255 is an FDA 510(k) clearance for the ZERAMEX T AND ZERAMEX PLUS DENTAL IMPLANT SYSTEMS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Dentalpoint AG (Dundas, CA). The FDA issued a Cleared decision on August 12, 2014 after a review of 293 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 Dentalpoint AG devices

FDA 510(k) Submission Details - K133255

510(k) Number K133255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2013
Decision Date August 12, 2014
Days to Decision 293 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
166d slower than avg
Panel avg: 127d · This submission: 293d
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 1182
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K133255.
ZL MICRODENT NATURAL LOCK IMPLANT SYSTEM
K133706 · Zl Microdent-Attachment GmbH & Co. KG · Aug 2014
ANKYLOS C/X IMPLANT SYSTEM
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STRAUMANN BONE LEVEL TAPERED IMPLANT
K140878 · Straumann USA, LLC · Aug 2014
ISY
K133991 · Altatec GmbH · Aug 2014
Z5C
K132881 · Z-Systems AG · Jul 2014
SATURNO(TM) OVERDENTURE IMPLANT SYSTEM
K133327 · Zest Anchors, LLC · Jun 2014