Cleared Traditional

K091051 - BOLLARD MINIPLATE SKELETAL ANCHORAGE SYSTEM

K091051 is an FDA 510(k) clearance for BOLLARD MINIPLATE SKELETAL ANCHORAGE SYSTEM, manufactured by Tita-Link. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K091051 · Tita-Link · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
239d
Days
Class 2
Risk

K091051 is an FDA 510(k) clearance for the BOLLARD MINIPLATE SKELETAL ANCHORAGE SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Tita-Link (Shelton, US). The FDA issued a Cleared decision on December 8, 2009 after a review of 239 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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 - K091051

510(k) Number K091051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2009
Decision Date December 08, 2009
Days to Decision 239 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
111d slower than avg
Panel avg: 128d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 - DZE Implant, Endosseous, Root-form

All 1500
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K091051.
UNO NARROW IMPLANT
K092555 · Mis Implants Technologies , Ltd. · Jan 2010
SIMPLER TOADSTOOL MINI IMPLANT
K092674 · Pan Global Implant · Dec 2009
3.25 SPLINE TWIST IMPLANT, HA COATED
K093164 · Zimmer Dental, Inc. · Dec 2009
HG III FIXTURE SYSTEM
K093352 · Hiossen, Inc. · Nov 2009
STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM
K092434 · Sterngold · Nov 2009
BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION
K092035 · Bicon, LLC · Oct 2009
K091051 · BOLLARD MINIPLATE SKELETAL ANCHORAGE SYSTEM
Download PDF FDA Summary Tita-Link