Cleared Traditional

K896249 - BANDTITE GLASS IONOMER CEMENT

K896249 is the FDA 510(k) clearance for BANDTITE GLASS IONOMER CEMENT by American Orthodontics. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K896249 · American Orthodontics · Dental device
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Jan 1990
Decision
88d
Days
Class 2
Risk

K896249 is an FDA 510(k) clearance for the BANDTITE GLASS IONOMER CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on January 26, 1990 after a review of 88 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 American Orthodontics devices

Submission Details

510(k) Number K896249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1989
Decision Date January 26, 1990
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 127d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 254
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K896249.
GLASION
K895386 · Scientific Pharmaceuticals, Inc. · Apr 1990
TEMPORARY DENTAL CEMENT
K895487 · Dentsply Intl. · Apr 1990
KETAC-CEM MAXICAP
K897188 · Espe GmbH (Us) · Mar 1990
CHELON-FIL
K884475 · Espe GmbH (Us) · Dec 1988
INTERIM, TEMPORARY CEMENT
K884081 · Scientific Pharmaceuticals, Inc. · Dec 1988
KETAC-BOND APLICAP
K874788 · Espe GmbH (Us) · Apr 1988