Cleared Traditional

URIS Smart Path Implant System & Prosthetic (K230438) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230438 · Truabutment, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2023
Decision
311d
Days
Class 2
Risk

K230438 is an FDA 510(k) clearance for the URIS Smart Path Implant System & Prosthetic. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Truabutment, Inc. (Irvine, US). The FDA issued a Cleared decision on December 29, 2023 after a review of 311 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Truabutment, Inc. devices

Submission Details

510(k) Number K230438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2023
Decision Date December 29, 2023
Days to Decision 311 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
184d slower than avg
Panel avg: 127d · This submission: 311d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 304
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K230438.
Straumann® BLC and TLC Implants - Line extension
K234049 · Institut Straumann AG · Mar 2024
S-Plant Dental Implant System
K221866 · Newton Implant Systems, Inc. · Jan 2024
UniFit Dental Implant System
K223714 · Adin Dental Implant Systems , Ltd. · Dec 2023
ZENEX Implant System_Short
K233163 · Izenimplant Co., Ltd. · Dec 2023
S-Plant Dental Implant System
K231429 · Idis Co., Ltd. · Dec 2023
S.I.N. Dental Implant System
K231127 · S.I.N. ? Sistema DE Implante Nacional S.A. · Dec 2023