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)
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.

View all Sybron Dental Specialties, Inc. devices

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
55d faster than avg
Panel avg: 127d · 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 43
Devices cleared under the same product code (EJJ) and FDA review panel - the closest regulatory comparables to K940675.
GALLOY
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TYTIN
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K913175 · G-C Intl. Corp. · Dec 1991
DW 236
K905204 · Ivoclar North America, Inc. · Mar 1991