Cleared Traditional

K133991 - ISY

K133991 is the FDA 510(k) clearance for ISY by Altatec GmbH. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K133991 · Altatec GmbH · Dental device
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Aug 2014
Decision
223d
Days
Class 2
Risk

K133991 is an FDA 510(k) clearance for the ISY. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Altatec GmbH (San Diego, US). The FDA issued a Cleared decision on August 6, 2014 after a review of 223 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 Altatec GmbH devices

Submission Details

510(k) Number K133991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2013
Decision Date August 06, 2014
Days to Decision 223 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 127d · This submission: 223d
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 589
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K133991.
Hahn Tapered Implant System
K143353 · Prismatik Dentalcraft, Inc. · Apr 2015
BioHorizons Tapered Internal Implants
K143022 · BioHorizons Implant Systems, Inc. · Jan 2015
ZIMMER 3.1MM DENTAL IMPLANT
K142082 · Zimmer Dental, Inc. · Oct 2014
NOBELACTIVE WIDE PLATFORM (WP)
K133731 · Nobel Biocare AB · May 2014
ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED
K133339 · Zimmer Dental, Inc. · Mar 2014
ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM
K132258 · Zimmer Dental, Inc. · Nov 2013