Cleared Traditional

K061658 - SPIRIT, MODEL M, U

Also marketed or referenced as:
DOCPORTMACRO, MODEL M, U, L

K061658 is an FDA 510(k) clearance for SPIRIT, manufactured by Dentall Corp.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K061658 · Dentall Corp. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
97d
Days
Class 2
Risk

K061658 is an FDA 510(k) clearance for the SPIRIT, MODEL M, U. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Dentall Corp. (Irvine, US). The FDA issued a Cleared decision on September 18, 2006 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6070 - 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 - K061658

510(k) Number K061658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2006
Decision Date September 18, 2006
Days to Decision 97 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 128d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBZ Device Classification - Class 2, Special Controls

Product Code EBZ Activator, Ultraviolet, For Polymerization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6070
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 - EBZ Activator, Ultraviolet, For Polymerization

All 204
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K061658.
DEMETRON A.2
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K061341 · CAO Group, Inc. · Jun 2006
K061658 · SPIRIT, MODEL M, U
Download PDF FDA Summary Dentall Corp.