Cleared Traditional

K080397 - AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM

K080397 is an FDA 510(k) clearance for AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM, manufactured by American Dental Implant Corporation. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K080397 · American Dental Implant Corporation · Dental device
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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

FDA 510(k) Submission Details - K080397

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.

NHA Device Classification - Class 2, Special Controls

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 567
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