Cleared Abbreviated

K063106 - REVOIS IMPLANT SYSTEM

K063106 is an FDA 510(k) clearance for REVOIS IMPLANT SYSTEM, manufactured by Curasan AG. The device is a Class 2 Dental device with product code NHA cleared through the Abbreviated 510(k) pathway after a 243-day FDA review.

K063106 · Curasan AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
243d
Days
Class 2
Risk

K063106 is an FDA 510(k) clearance for the REVOIS IMPLANT 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 Curasan AG (Garner,, US). The FDA issued a Cleared decision on June 11, 2007 after a review of 243 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 Curasan AG devices

FDA 510(k) Submission Details - K063106

510(k) Number K063106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2006
Decision Date June 11, 2007
Days to Decision 243 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 127d · This submission: 243d
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 567
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K063106.
NARROW NECK TEMPORARY COPING
K070744 · Institut Straumann AG · Jun 2007
TITANIUM SCALLOPED ABUTMENT
K063768 · Vident · Jun 2007
ATLANTIS ABUTMENT FOR ASTRA IMPLANT
K070833 · Atlantis Components, Inc. · Jun 2007
WN SYNOCTA GOLD ABUTMENT
K063789 · Straumann USA · May 2007
STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CERAMIC COPING
K061277 · Straumann USA · Apr 2007
CONICAL ANGLED ABUTMENT
K063403 · Implant Innovations, Inc. · Mar 2007