Cleared Special

CAM STRUCTSURE BARS (K101582) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K101582 · Biomet 3i, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
154d
Days
Class 2
Risk

K101582 is an FDA 510(k) clearance for the CAM STRUCTSURE BARS. 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 Biomet 3i, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on November 8, 2010 after a review of 154 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biomet 3i, Inc. devices

Submission Details

510(k) Number K101582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2010
Decision Date November 08, 2010
Days to Decision 154 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 127d · This submission: 154d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 705
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K101582.
SIC Abutments including CAD/CAM Solutions
K252904 · Sic Invent AG · Jun 2026
Elos Accurate® Denture Fixation System
K253774 · Elos Medtech Pinol A/S · May 2026
ET Healing Abutments
K253372 · Hiossen, Inc. · May 2026
Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue
K260460 · Institut Straumann AG · May 2026
DESS Dental Smart Solutions
K253804 · Terrats Medical SL · Apr 2026
LOCATOR® Angled Abutment
K260555 · Zest Anchors, LLC · Apr 2026