Cleared Traditional

K100411 - VARIOUS DENTAL IMPLANTS

K100411 is an FDA 510(k) clearance for VARIOUS DENTAL IMPLANTS, manufactured by Grundy Advanced Biomedical Systems, LLC. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K100411 · Grundy Advanced Biomedical Systems, LLC · Dental device
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Jul 2010
Decision
162d
Days
Class 2
Risk

K100411 is an FDA 510(k) clearance for the VARIOUS DENTAL IMPLANTS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Grundy Advanced Biomedical Systems, LLC (Marion, US). The FDA issued a Cleared decision on July 28, 2010 after a review of 162 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.

FDA 510(k) Submission Details - K100411

510(k) Number K100411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2010
Decision Date July 28, 2010
Days to Decision 162 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 128d · This submission: 162d
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 1500
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K100411.
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K101977 · Zimmer Dental, Inc. · Sep 2010
STAR/VENT INTERNAL HEX SCREW IMPLANT
K082800 · Park Dental Research Corp. · Aug 2010
NEODENT IMPLANT SYSTEM
K101207 · Jjgc Industria E Comercio DE Materiais Dentarios S · Aug 2010
DEFCON TSA/TSH DENTAL IMPLANT SYSTEM
K092261 · Impladent, S.L. · Jul 2010
SARGON NON-EXPANDABLE DENTAL IMPLANT
K082573 · Sargon Ent., Inc. · Jul 2010
COTEC DENTAL IMPLANT SYSTEM
K100511 · Cotec Implant Co., Ltd. · Jul 2010
K100411 · VARIOUS DENTAL IMPLANTS
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