Cleared Traditional

K023067 - IMTEC SENDAX MDI ORTHO6 AND ORTHO8

K023067 is the FDA 510(k) clearance for IMTEC SENDAX MDI ORTHO6 AND ORTHO8 by Imtec Corp.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K023067 · Imtec Corp. · Dental device
Download Printable Device Report (PDF)
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Dec 2002
Decision
78d
Days
Class 2
Risk

K023067 is an FDA 510(k) clearance for the IMTEC SENDAX MDI ORTHO6 AND ORTHO8. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Imtec Corp. (Ardmore, US). The FDA issued a Cleared decision on December 3, 2002 after a review of 78 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Imtec Corp. devices

Submission Details

510(k) Number K023067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2002
Decision Date December 03, 2002
Days to Decision 78 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
49d faster than avg
Panel avg: 127d · This submission: 78d
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 698
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K023067.
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