Cleared Traditional

K951663 - TYTIN R

K951663 is the FDA 510(k) clearance for TYTIN R by Kerr Corporation (Danbury). It is a Class 2 Dental device (product code EJJ) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K951663 · Kerr Corporation (Danbury) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
57d
Days
Class 2
Risk

K951663 is an FDA 510(k) clearance for the TYTIN R. 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 June 6, 1995 after a review of 57 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kerr Corporation (Danbury) devices

Submission Details

510(k) Number K951663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1995
Decision Date June 06, 1995
Days to Decision 57 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
70d faster than avg
Panel avg: 127d · This submission: 57d
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 21
Devices cleared under the same product code (EJJ) and FDA review panel - the closest regulatory comparables to K951663.
CENTURY ALLOY
K974035 · Dentsply Intl. · Dec 1997
TYTIN ADMIX
K951511 · Kerr Corporation (Danbury) · May 1995
SYBRALOY
K940675 · Sybron Dental Specialties, Inc. · Apr 1994
TYTIN
K935535 · Kerr Corporation (Danbury) · Mar 1994
DW 236
K905204 · Ivoclar North America, Inc. · Mar 1991
DW 235
K905205 · Ivoclar North America, Inc. · Dec 1990