Cleared Traditional

K935689 - IONOSIT BASE LINER

K935689 is an FDA 510(k) clearance for IONOSIT BASE LINER, manufactured by Foremost Dental Mfg., Co.. The device is a Class 2 Dental device with product code EBD cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K935689 · Foremost Dental Mfg., Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
53d
Days
Class 2
Risk

K935689 is an FDA 510(k) clearance for the IONOSIT BASE LINER. Classified as Coating, Filling Material, Resin (product code EBD), Class II - Special Controls.

Submitted by Foremost Dental Mfg., Co. (Englewood, US). The FDA issued a Cleared decision on January 21, 1994 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3310 - 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 Foremost Dental Mfg., Co. devices

FDA 510(k) Submission Details - K935689

510(k) Number K935689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1993
Decision Date January 21, 1994
Days to Decision 53 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 127d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBD Device Classification - Class 2, Special Controls

Product Code EBD Coating, Filling Material, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3310
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 - EBD Coating, Filling Material, Resin

All 47
Devices cleared under the same product code (EBD) and FDA review panel - the closest regulatory comparables to K935689.
CORE-IDE
K984037 · Roydent Dental Products, Inc. · Feb 1999
FLOWABLE HYBRID
K980298 · Cosmedent, Inc. · Mar 1998
RENAMEL FLOWABLE COMPOSITE
K974494 · Cosmedent, Inc. · Feb 1998
NO-STICK COMPOSITE INSTRUMENT DIP
K901050 · Pulpdent Corp. · Apr 1990
3M ESTHETIC DESIGN SYSTEM (TINTS & MASKING AGENTS)
K862590 · 3M Company · Jul 1986
AUSTENAL DENTAL COMPOSITE RESIN
K854957 · Austenal Dental, Inc. · Jan 1986