Cleared Traditional

SIMPLER MINI DENTAL IMPLANT: SM 3002 2.5 X 10MM, SM 3003 2.5 X 13MM, SM 3004 2.5 X 15MM (K073645) - FDA 510(k) Clearance

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

K073645 · 659543 BC , Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
300d
Days
Class 2
Risk

K073645 is an FDA 510(k) clearance for the SIMPLER MINI DENTAL IMPLANT: SM 3002 2.5 X 10MM, SM 3003 2.5 X 13MM, SM 3004 .... Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by 659543 BC , Ltd. (Vancouver, CA). The FDA issued a Cleared decision on October 21, 2008 after a review of 300 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. 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 659543 BC , Ltd. devices

Submission Details

510(k) Number K073645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2007
Decision Date October 21, 2008
Days to Decision 300 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
173d slower than avg
Panel avg: 127d · This submission: 300d
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

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