Cleared Traditional

K990448 - THE.R.MO.FREE

K990448 is an FDA 510(k) clearance for THE.R.MO.FREE, manufactured by Dentamax, Inc.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K990448 · Dentamax, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
39d
Days
Class 2
Risk

K990448 is an FDA 510(k) clearance for the THE.R.MO.FREE. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Dentamax, Inc. (Corvallis, US). The FDA issued a Cleared decision on March 23, 1999 after a review of 39 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 Dentamax, Inc. devices

FDA 510(k) Submission Details - K990448

510(k) Number K990448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1999
Decision Date March 23, 1999
Days to Decision 39 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 127d · This submission: 39d
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 204
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K990448.
ORTHO-GLOW GLITTER
K990699 · Harry J. Bosworth Co. · May 1999
UNI-FLEX RESIN
K983461 · Trans-Atlantic Dental · Apr 1999
JELDENT MULTICRYL
K990056 · J.F. Jelenko & Co., Inc. · Mar 1999
GC UNIFAST TRAD
K984365 · GC America, Inc. · Feb 1999
FUSICRYL
K984467 · Micro Dental Laboratories · Feb 1999
A-SOFT RELINER
K984483 · S & C Polymer GmbH · Feb 1999