Cleared Traditional

K991172 - IONOSIT BOND

K991172 is an FDA 510(k) clearance for IONOSIT BOND, manufactured by Dmg Chemisch Pharmazeutische Fabrik GmbH. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K991172 · Dmg Chemisch Pharmazeutische Fabrik GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
40d
Days
Class 2
Risk

K991172 is an FDA 510(k) clearance for the IONOSIT BOND. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Dmg Chemisch Pharmazeutische Fabrik GmbH (Ayer, US). The FDA issued a Cleared decision on May 17, 1999 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 Dmg Chemisch Pharmazeutische Fabrik GmbH devices

FDA 510(k) Submission Details - K991172

510(k) Number K991172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1999
Decision Date May 17, 1999
Days to Decision 40 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
87d faster than avg
Panel avg: 127d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 345
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K991172.
NEXUS 2
K992160 · Sybron Dental Specialties, Inc. · Aug 1999
BISTITE II SC
K991711 · Tokuyama America, Inc. · Jul 1999
TOTALBOND
K990381 · Parkell, Inc. · May 1999
MIRACLE MIX POWDER/LIQUID
K984505 · GC America, Inc. · Feb 1999
PROCEM
K984248 · Espe Dental AG · Jan 1999
ALUMINA-ZINC OXIDE POWDERS F AND R
K983752 · Harry J. Bosworth Co. · Dec 1998