Cleared Traditional

K083100 - GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP

K083100 is an FDA 510(k) clearance for GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, manufactured by Nobel Biocare USA, LLC. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K083100 · Nobel Biocare USA, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
30d
Days
Class 2
Risk

K083100 is an FDA 510(k) clearance for the GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP.... 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 Nobel Biocare USA, LLC (Yorba Linda,, US). The FDA issued a Cleared decision on November 19, 2008 after a review of 30 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 Nobel Biocare USA, LLC devices

FDA 510(k) Submission Details - K083100

510(k) Number K083100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2008
Decision Date November 19, 2008
Days to Decision 30 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 127d · This submission: 30d
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 559
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K083100.
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K081666 · Astra Tech, Inc. · Oct 2008
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K082764 · Institut Straumann AG · Oct 2008