Cleared Traditional

K971138 - DINABASE (TM)

K971138 is an FDA 510(k) clearance for DINABASE (TM), manufactured by Sultan Chemists, Inc.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K971138 · Sultan Chemists, Inc. · Dental device
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Jul 1997
Decision
115d
Days
Class 2
Risk

K971138 is an FDA 510(k) clearance for the DINABASE (TM). Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Sultan Chemists, Inc. (Englewood, US). The FDA issued a Cleared decision on July 21, 1997 after a review of 115 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 Sultan Chemists, Inc. devices

FDA 510(k) Submission Details - K971138

510(k) Number K971138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1997
Decision Date July 21, 1997
Days to Decision 115 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
12d faster than avg
Panel avg: 127d · This submission: 115d
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 200
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K971138.
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LIQCRYLIC PRO DENTAL RESIN
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MYERSON'S ECONOMY DENTURE BASE MATERIAL
K970522 · Austenal, Inc. · May 1997
TRUBYTE SOFT RELINE SYSTEM
K964040 · Dentsply Intl. · Dec 1996
SOFT DENTURE REBASING RESIN
K963736 · Sybron Dental Specialties, Inc. · Dec 1996