Cleared Traditional

TRUETECH MEDICAL, INC. DENTURE CUPS (K871160) - FDA 510(k) Clearance

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

K871160 · Zenex Medical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1987
Decision
91d
Days
Class 2
Risk

K871160 is an FDA 510(k) clearance for the TRUETECH MEDICAL, INC. DENTURE CUPS. Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by Zenex Medical, Inc. (Chicago, US). The FDA issued a Cleared decision on June 23, 1987 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3590 - 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 Zenex Medical, Inc. devices

Submission Details

510(k) Number K871160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1987
Decision Date June 23, 1987
Days to Decision 91 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 127d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELM Denture, Plastic, Teeth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3590
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 - ELM Denture, Plastic, Teeth

All 7
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K871160.
ARTIC
K033628 · Heraeus Kulzer, Inc. · Jan 2004
PREMIUM
K011130 · Heraeus Kulzer, Inc. · Jul 2001
NEW TOOTH MATERIAL
K920684 · Dentsply Intl. · Dec 1992
DELTA TEETH
K831214 · Dentsply Intl. · May 1983
TEETH, DENTURE, PLASTIC
K792245 · Dentsply Intl. · Jan 1980
ANTERIORS AND POSTERIORS, PLASTIC
K780217 · Dentsply Intl. · Mar 1978