Cleared Traditional

K072660 - ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114

K072660 is an FDA 510(k) clearance for ENDURE 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 82-day FDA review.

K072660 · Imtec Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
82d
Days
Class 2
Risk

K072660 is an FDA 510(k) clearance for the ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114. 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 12, 2007 after a review of 82 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

FDA 510(k) Submission Details - K072660

510(k) Number K072660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2007
Decision Date December 12, 2007
Days to Decision 82 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 127d · This submission: 82d
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 K072660.
NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM
K070857 · Nobel Biocare AB · Dec 2007
NOBELPERFECT CONICAL CONNECTION HEXAGONAL IMPLANTS
K072980 · Nobel Biocare AB · Dec 2007
SCREWPLUS DENTAL IMPLANTS (HA)
K073049 · Implant Direct, LLC · Dec 2007
LEGACY DENTAL IMPLANTS
K073033 · Implant Direct, LLC · Dec 2007
SPI SYSTEM DENTAL IMPLANTS
K072649 · Thommen Medical AG · Dec 2007
IMPLUS IMPLANT SYSTEM
K062931 · Leader Italia S.R.L. · Nov 2007