Cleared Traditional

ORTHODONTICARTIDE (K800458) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K800458 · European Orthodontic Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1980
Decision
25d
Days
Class 2
Risk

K800458 is an FDA 510(k) clearance for the ORTHODONTICARTIDE. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by European Orthodontic Products (Mchenry, US). The FDA issued a Cleared decision on March 25, 1980 after a review of 25 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 European Orthodontic Products devices

Submission Details

510(k) Number K800458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 1980
Decision Date March 25, 1980
Days to Decision 25 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 127d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 90
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K800458.
TRIAD IMPACT
K863324 · Dentsply Intl. · Sep 1986
DENTURE BASE RESIN
K834409 · Dentsply Intl. · Feb 1984
DENTURE RELINING, REPAIR/REBASING RESIN
K831647 · Dentsply Intl. · Jun 1983
MAXUM DENTURE RESIN
K800400 · Dentsply Intl. · Mar 1980
DENTURE BASE RESIN
K792042 · Dentsply Intl. · Nov 1979
DENTURE RELINE MATERIAL
K780786 · Dentsply Intl. · Jun 1978