Cleared Traditional

K940675 - SYBRALOY

K940675 is an FDA 510(k) clearance for SYBRALOY, manufactured by Sybron Dental Specialties, Inc.. The device is a Class 2 Dental device with product code EJJ cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K940675 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
72d
Days
Class 2
Risk

K940675 is an FDA 510(k) clearance for the SYBRALOY. Classified as Alloy, Amalgam (product code EJJ), Class II - Special Controls.

Submitted by Sybron Dental Specialties, Inc. (Glendora, US). The FDA issued a Cleared decision on April 29, 1994 after a review of 72 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.

FDA 510(k) Submission Details - K940675

510(k) Number K940675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1994
Decision Date April 29, 1994
Days to Decision 72 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
56d faster than avg
Panel avg: 128d · This submission: 72d
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 70
Devices cleared under the same product code (EJJ) and FDA review panel - the closest regulatory comparables to K940675.
ULTRA SPHERICAL AMALGAM ALLOY
K951865 · Goldsmith & Revere, Inc. · May 1995
TYTIN ADMIX
K951511 · Kerr Corporation (Danbury) · May 1995
AGALLOY, DISALLOY, EPSILON AND LAMBDA
K942430 · Fen Dental Mfg., Inc. · Jul 1994
TYTIN
K935535 · Kerr Corporation (Danbury) · Mar 1994
INDIPERSE
K936113 · Indisperse Distributing, Inc. · Feb 1994
PRINCE
K933309 · Goldsmith & Revere, Inc. · Oct 1993
K940675 · SYBRALOY
Download PDF FDA Summary Sybron Dental Special…