Cleared Special

K081186 - CONCAVE RN HEALING CAP

K081186 is an FDA 510(k) clearance for CONCAVE RN HEALING CAP, manufactured by Institut Straumann AG. The device is a Class 2 Dental device with product code NHA cleared through the Special 510(k) pathway after a 25-day FDA review.

K081186 · Institut Straumann AG · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
25d
Days
Class 2
Risk

K081186 is an FDA 510(k) clearance for the CONCAVE RN HEALING CAP. 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 Institut Straumann AG (Andover, US). The FDA issued a Cleared decision on May 23, 2008 after a review of 25 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K081186

510(k) Number K081186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2008
Decision Date May 23, 2008
Days to Decision 25 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 128d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 715
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K081186.
HU/HS/HG PROSTHETIC SYSTEM
K081575 · Osstem Implant Co., Ltd. · Sep 2008
ACCUFRAME
K081157 · Cagenix, Inc. · Jul 2008
CAM STRUCTSURE PRECISION MILLED BARS
K080864 · Biomet 3i, Inc. · Jul 2008
MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS
K080598 · Intra-Lock International · May 2008
INCLUSIVE IMPLANT ABUTMENTS
K073217 · Inclusive Dental Solutions · May 2008
AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM
K080397 · American Dental Implant Corporation · May 2008
K081186 · CONCAVE RN HEALING CAP
Download PDF FDA Summary Institut Straumann AG