Cleared Traditional

AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM (K080397) - FDA 510(k) Clearance

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

K080397 · American Dental Implant Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
83d
Days
Class 2
Risk

K080397 is an FDA 510(k) clearance for the AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by American Dental Implant Corporation (New Castle, US). The FDA issued a Cleared decision on May 6, 2008 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - 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 American Dental Implant Corporation devices

Submission Details

510(k) Number K080397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2008
Decision Date May 06, 2008
Days to Decision 83 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 127d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
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 - NHA Abutment, Implant, Dental, Endosseous

All 705
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K080397.
SIC Abutments including CAD/CAM Solutions
K252904 · Sic Invent AG · Jun 2026
Elos Accurate® Denture Fixation System
K253774 · Elos Medtech Pinol A/S · May 2026
ET Healing Abutments
K253372 · Hiossen, Inc. · May 2026
Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue
K260460 · Institut Straumann AG · May 2026
DESS Dental Smart Solutions
K253804 · Terrats Medical SL · Apr 2026
LOCATOR® Angled Abutment
K260555 · Zest Anchors, LLC · Apr 2026