Cleared Traditional

SEVEN IMPLANTS (K103089) - FDA 510(k) Clearance

Also marketed or referenced as:
BIOCOM IMPLANTS LANCE IMPLANTS

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K103089 · Mis - Implant Technologies , Ltd. · Dental device
Download Printable Device Report (PDF)
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Sep 2011
Decision
331d
Days
Class 2
Risk

K103089 is an FDA 510(k) clearance for the SEVEN IMPLANTS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Mis - Implant Technologies , Ltd. (Bar Lev Industrial Park, IL). The FDA issued a Cleared decision on September 15, 2011 after a review of 331 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Mis - Implant Technologies , Ltd. devices

Submission Details

510(k) Number K103089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2010
Decision Date September 15, 2011
Days to Decision 331 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
204d slower than avg
Panel avg: 127d · This submission: 331d
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 1542
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