Cleared Traditional

K940845 - SYSTEM 1

K940845 is an FDA 510(k) clearance for SYSTEM 1, manufactured by Sybron Dental Specialties, Inc.. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K940845 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
36d
Days
Class 2
Risk

K940845 is an FDA 510(k) clearance for the SYSTEM 1. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Sybron Dental Specialties, Inc. (Glendora, US). The FDA issued a Cleared decision on March 31, 1994 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3750 - 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 - K940845

510(k) Number K940845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1994
Decision Date March 31, 1994
Days to Decision 36 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
91d faster than avg
Panel avg: 127d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYH Device Classification - Class 2, Special Controls

Product Code DYH Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3750
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 - DYH Adhesive, Bracket And Tooth Conditioner, Resin

All 136
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K940845.
ALPHA BOND-RITE II(TM) OR BOND-RITE II(TM) 2-PASTE ADHEV
K942742 · Wallace A. Erickson & Co. · Aug 1994
ALPHA BOUND-RITE I NO-MIX ADHESIVE OR BOND-RITE I NO-MIX ADHESIVE
K942727 · Wallace A. Erickson & Co. · Aug 1994
ALPHADENT LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM WITH FLUORIDE
K935625 · Wallace A. Erickson & Co. · Aug 1994
ORMCO SYSTEM 1+ (TM)
K941015 · Ormco Corp. · Mar 1994
CRYSTALLINE L3 MULTI-USE HYBRID COMPOSITE
K935714 · Confi-Dental Products Co. · Jan 1994
RESILIENCE ORTHODONTIC BRACKET ADHES W/BOND RESINS
K925359 · Confi-Dental Products Co. · Jul 1993