Cleared Traditional

TYTIN (K935535) - FDA 510(k) Clearance

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

K935535 · Kerr Corporation (Danbury) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
115d
Days
Class 2
Risk

K935535 is an FDA 510(k) clearance for the TYTIN. Classified as Alloy, Amalgam (product code EJJ), Class II - Special Controls.

Submitted by Kerr Corporation (Danbury) (Glendora, US). The FDA issued a Cleared decision on March 11, 1994 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3070 - 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 Kerr Corporation (Danbury) devices

Submission Details

510(k) Number K935535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1993
Decision Date March 11, 1994
Days to Decision 115 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
12d faster than avg
Panel avg: 127d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJJ Alloy, Amalgam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3070
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 - EJJ Alloy, Amalgam

All 73
Devices cleared under the same product code (EJJ) and FDA review panel - the closest regulatory comparables to K935535.
CENTURY ALLOY
K974035 · Dentsply Intl. · Dec 1997
VALULINE* AMALGAM ALLOY
K821971 · Johnson & Johnson Professionals, Inc. · Jul 1982
A DENTAL AMALGAM ALLOY (UNNAMED
K820389 · Dentsply Intl. · Mar 1982
ORBIC* SPHERICAL ALLOY
K812827 · Johnson & Johnson Professionals, Inc. · Nov 1981
ALLOY DISPOS-A-CAP DENTAL SCHOOL CAP
K771383 · Johnson & Johnson Professionals, Inc. · Aug 1977