Cleared Special

K060376 - SIMPLER HA THREADED, ST 5002-8, SIT 5002-8, ST 5011-ST5014, ST 5021-24

K060376 is an FDA 510(k) clearance for SIMPLER HA THREADED, manufactured by Simpler Implant, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 70-day FDA review.

K060376 · Simpler Implant, Inc. · Dental device
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Apr 2006
Decision
70d
Days
Class 2
Risk

K060376 is an FDA 510(k) clearance for the SIMPLER HA THREADED, ST 5002-8, SIT 5002-8, ST 5011-ST5014, ST 5021-24. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Simpler Implant, Inc. (Vancouver, Bc, CA). The FDA issued a Cleared decision on April 25, 2006 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K060376

510(k) Number K060376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2006
Decision Date April 25, 2006
Days to Decision 70 days
Submission Type Special
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
58d faster than avg
Panel avg: 128d · This submission: 70d
Pathway characteristics
Modification to existing cleared device.

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 1542
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K060376.
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K060957 · Blue Sky Bio, LLC · May 2006
RESCUE IMPLANT SYSTEM
K053353 · Megagen Co., Ltd. · Apr 2006
INTERMEZZO PLUS FIXTURE
K053354 · Megagen Co., Ltd. · Apr 2006
OSTEOMED ORTHODONTIC ANCHOR PLATING SYSTEM
K051798 · Osteomed LP · Apr 2006
K060376 · SIMPLER HA THREADED, ST 5002-8, SIT 5002-8, ST 5011-ST5014, ST 5021-24
Download PDF Simpler Implant, Inc.