Cleared Traditional

K092341 - LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION

K092341 is an FDA 510(k) clearance for LOW PROFILE ABUTMENTS - INTERNAL AND EX..., 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 118-day FDA review.

K092341 · Biomet 3i, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
118d
Days
Class 2
Risk

K092341 is an FDA 510(k) clearance for the LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION. 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 30, 2009 after a review of 118 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.

View all Biomet 3i, Inc. devices

FDA 510(k) Submission Details - K092341

510(k) Number K092341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2009
Decision Date November 30, 2009
Days to Decision 118 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 127d · This submission: 118d
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 563
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K092341.
STRAUMANN MODIFIED DENTAL ABUTMENT
K091701 · Institut Straumann AG · Dec 2009
ATLANTIS ABUTMENT FOR NOBEL BIOCARE ACTIVE IMPLANT, ATLANTIS GEMINI ABUTMENT, GEMINI + ABUTMENT
K093483 · Astra Tech, Inc. · Dec 2009
ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENT
K093113 · Institut Straumann AG · Dec 2009
PLASTIC TEMPORARY ABUTMENTS, MODELS: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S, PT451A, PT454A, PT561S, PT564S
K092377 · Zimmer Dental, Inc. · Nov 2009
TI PREPABLE ABUTMENT, MODEL 1618, 1619, 1620
K092403 · Zimmer Dental, Inc. · Oct 2009
NOBEL/PROCERA IMPLANT BRIDGE
K091848 · Nobel Biocare AB · Oct 2009