Cleared Traditional

K954689 - CONNECT

K954689 is an FDA 510(k) clearance for CONNECT, manufactured by Sybron Dental Specialties, Inc.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K954689 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
19d
Days
Class 2
Risk

K954689 is an FDA 510(k) clearance for the CONNECT. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Sybron Dental Specialties, Inc. (Glendora, US). The FDA issued a Cleared decision on October 30, 1995 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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 - K954689

510(k) Number K954689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1995
Decision Date October 30, 1995
Days to Decision 19 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
108d faster than avg
Panel avg: 127d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 220
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K954689.
BOSWORTH LIQUID RESIN II
K961200 · Harry J. Bosworth Co. · May 1996
TOKUYAMA SOFT RELINING
K953589 · Tokuyama America, Inc. · Jan 1996
AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER
K954637 · American Dental Products, Inc. · Dec 1995
PALASPLINT
K953743 · Heraeus Kulzer, Inc. · Oct 1995
PROP. CONQUEST C&B VLC GLAZE/SEALANT
K953381 · Jeneric/Pentron, Inc. · Sep 1995
PRECISE DENTURE BASE RESIN
K952351 · Dentsply Intl. · Jul 1995