Cleared Traditional

K081653 - MDI MII ONE-PIECE IMPLANT, 2.9MM

K081653 is an FDA 510(k) clearance for MDI MII ONE-PIECE IMPLANT, manufactured by Imtec Corp.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K081653 · Imtec Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
99d
Days
Class 2
Risk

K081653 is an FDA 510(k) clearance for the MDI MII ONE-PIECE IMPLANT, 2.9MM. 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 September 19, 2008 after a review of 99 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 Imtec Corp. devices

FDA 510(k) Submission Details - K081653

510(k) Number K081653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2008
Decision Date September 19, 2008
Days to Decision 99 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
28d faster than avg
Panel avg: 127d · This submission: 99d
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 1300
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K081653.
GS III FIXTURE SYSTEM
K082213 · Osstem Implant Co., Ltd. · Oct 2008
5.0 X 5.0MM DENTAL IMPLANT AND 6.0 X 5.0 DENTAL IMPLANT
K073368 · Bicon, LLC · Oct 2008
DIO SM IMPLANT SYSTEM
K080559 · Dsi, Inc. · Oct 2008
OSSEOSPEED TM PROFILE SYSTEM
K080156 · Astra Tech AB · Sep 2008
INVENTUS IMPLANT SYSTEM
K081579 · Inventus Co., Ltd. · Sep 2008
SIMPACT IMPLANT SYSTEM
K081226 · Simpact, LLC · Sep 2008