Cleared Traditional

K983547 - PROTECH PLUS

K983547 is an FDA 510(k) clearance for PROTECH PLUS, manufactured by Protech, Inc.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K983547 · Protech, Inc. · Dental device
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Jan 1999
Decision
90d
Days
Class 2
Risk

K983547 is an FDA 510(k) clearance for the PROTECH PLUS. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Protech, Inc. (Boca Raton, US). The FDA issued a Cleared decision on January 7, 1999 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Protech, Inc. devices

FDA 510(k) Submission Details - K983547

510(k) Number K983547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1998
Decision Date January 07, 1999
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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 217
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K983547.
A-SOFT RELINER
K984483 · S & C Polymer GmbH · Feb 1999
RESIN 4
K981862 · Harry J. Bosworth Co. · Feb 1999
STERNVANTAGE VARNISH LC, MODEL 221001
K984341 · Sterngold/Implamed · Jan 1999
MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC
K983876 · Mycone Dental Supply Co., Inc. (A/K/A Keystone Ind · Dec 1998
MUCOPREN SOFT RELINING SYSTEM
K983357 · Roydent Dental Products, Inc. · Nov 1998
SILICONE SOFT RELINE
K981691 · Harry J. Bosworth Co. · Nov 1998