Cleared Traditional

K081806 - IDI IMPLANT SYSTEM

K081806 is an FDA 510(k) clearance for IDI IMPLANT SYSTEM, manufactured by Idi Biomedical, LLC. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K081806 · Idi Biomedical, LLC · Dental device
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Nov 2008
Decision
134d
Days
Class 2
Risk

K081806 is an FDA 510(k) clearance for the IDI IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Idi Biomedical, LLC (Catawba, US). The FDA issued a Cleared decision on November 7, 2008 after a review of 134 days - within the typical 510(k) review window.

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 Idi Biomedical, LLC devices

FDA 510(k) Submission Details - K081806

510(k) Number K081806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2008
Decision Date November 07, 2008
Days to Decision 134 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
7d slower than avg
Panel avg: 127d · This submission: 134d
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 938
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K081806.
ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS
K082639 · Zimmer Dental, Inc. · Dec 2008
BIOLOK MICRO-LOK IMPLANT SYSTEM
K081818 · BioHorizons Implant Systems, Inc. · Nov 2008
MOLAR IMPLANT
K081128 · Nobel Biocare AB · Nov 2008
TEMPORARY TOOTH REPLACEMENT
K081900 · Ormco Corp. · Oct 2008
GS III FIXTURE SYSTEM
K082213 · Osstem Implant Co., Ltd. · Oct 2008
MDI MII ONE-PIECE IMPLANT, 2.9MM
K081653 · Imtec Corp. · Sep 2008