Cleared Traditional

K080864 - CAM STRUCTSURE PRECISION MILLED BARS

K080864 is an FDA 510(k) clearance for CAM STRUCTSURE PRECISION MILLED BARS, manufactured by Biomet 3i, Inc.. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K080864 · Biomet 3i, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
115d
Days
Class 2
Risk

K080864 is an FDA 510(k) clearance for the CAM STRUCTSURE PRECISION MILLED 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 July 21, 2008 after a review of 115 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K080864

510(k) Number K080864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2008
Decision Date July 21, 2008
Days to Decision 115 days
Submission Type Traditional
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
13d faster than avg
Panel avg: 128d · This submission: 115d
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 715
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K080864.
ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT
K080164 · Zimmer Dental, Inc. · Sep 2008
HU/HS/HG PROSTHETIC SYSTEM
K081575 · Osstem Implant Co., Ltd. · Sep 2008
ACCUFRAME
K081157 · Cagenix, Inc. · Jul 2008
CONCAVE RN HEALING CAP
K081186 · Institut Straumann AG · May 2008
MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS
K080598 · Intra-Lock International · May 2008
INCLUSIVE IMPLANT ABUTMENTS
K073217 · Inclusive Dental Solutions · May 2008
K080864 · CAM STRUCTSURE PRECISION MILLED BARS
Download PDF FDA Summary Biomet 3i, Inc.