Cleared Abbreviated

K072100 - GC AADVA ABUTMENT

K072100 is an FDA 510(k) clearance for GC AADVA ABUTMENT, manufactured by GC America, Inc.. The device is a Class 2 Dental device with product code NHA cleared through the Abbreviated 510(k) pathway after a 198-day FDA review.

K072100 · GC America, Inc. · Dental device
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Feb 2008
Decision
198d
Days
Class 2
Risk

K072100 is an FDA 510(k) clearance for the GC AADVA ABUTMENT. 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 GC America, Inc. (Lake Forest, US). The FDA issued a Cleared decision on February 14, 2008 after a review of 198 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all GC America, Inc. devices

FDA 510(k) Submission Details - K072100

510(k) Number K072100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2007
Decision Date February 14, 2008
Days to Decision 198 days
Submission Type Abbreviated
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
71d slower than avg
Panel avg: 127d · This submission: 198d
Pathway characteristics
Standards-based clearance path.

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 649
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