Cleared Traditional

K935535 - TYTIN

K935535 is an FDA 510(k) clearance for TYTIN, manufactured by Kerr Corporation (Danbury). The device is a Class 2 Dental device with product code EJJ cleared through the Traditional 510(k) pathway after a 115-day FDA review.

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

FDA 510(k) Submission Details - K935535

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
Combination Product No
PCCP Authorized No
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.

EJJ Device Classification - Class 2, Special Controls

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 45
Devices cleared under the same product code (EJJ) and FDA review panel - the closest regulatory comparables to K935535.
TYTIN R
K951663 · Kerr Corporation (Danbury) · Jun 1995
TYTIN ADMIX
K951511 · Kerr Corporation (Danbury) · May 1995
SYBRALOY
K940675 · Sybron Dental Specialties, Inc. · Apr 1994
MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES
K913175 · G-C Intl. Corp. · Dec 1991
DW 236
K905204 · Ivoclar North America, Inc. · Mar 1991
DW 235
K905205 · Ivoclar North America, Inc. · Dec 1990