Cleared Traditional

K132956 - U FIT DENTAL IMPLANT SYSTEM

K132956 is an FDA 510(k) clearance for U FIT DENTAL IMPLANT SYSTEM, manufactured by T Strong, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K132956 · T Strong, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
258d
Days
Class 2
Risk

K132956 is an FDA 510(k) clearance for the U FIT DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by T Strong, Inc. (Brea, US). The FDA issued a Cleared decision on June 5, 2014 after a review of 258 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 - K132956

510(k) Number K132956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2013
Decision Date June 05, 2014
Days to Decision 258 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
130d slower than avg
Panel avg: 128d · This submission: 258d
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 1483
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K132956.
JR IMPLANT SYSTEM
K130694 · LK Consulting Group USA, Inc. · Jun 2014
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BIODENTA DENTAL IMPLANT SYSTEM-BONE LEVEL TAPERED D3.0 AND L6.5MM
K133884 · Biodenta Swiss AG · Jun 2014
ZIBONE CERAMIC DENTAL IMPLANT SYSTEM
K132585 · Coho Technology Co., Ltd. · Jun 2014
RITTER IMPLANT SYSTEM
K131557 · Ritter Implants GmbH CO KG · May 2014
NOBELACTIVE WIDE PLATFORM (WP)
K133731 · Nobel Biocare AB · May 2014
K132956 · U FIT DENTAL IMPLANT SYSTEM
Download PDF FDA Summary T Strong, Inc.