Cleared Traditional

K972198 - DENT-TEMP ACRYLIC

K972198 is an FDA 510(k) clearance for DENT-TEMP ACRYLIC, manufactured by Health-Dent Intl., Inc.. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K972198 · Health-Dent Intl., Inc. · Dental device
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Dec 1997
Decision
189d
Days
Class 2
Risk

K972198 is an FDA 510(k) clearance for the DENT-TEMP ACRYLIC. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Health-Dent Intl., Inc. (Oswego, US). The FDA issued a Cleared decision on December 17, 1997 after a review of 189 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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 Health-Dent Intl., Inc. devices

FDA 510(k) Submission Details - K972198

510(k) Number K972198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1997
Decision Date December 17, 1997
Days to Decision 189 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 127d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBG Device Classification - Class 2, Special Controls

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 113
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K972198.
SMARTEMP
K991270 · Parkell, Inc. · May 1999
HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL
K980799 · Cosmedent, Inc. · Oct 1998
TEMPFIL F - 2
K982459 · Sybron Dental Specialties, Inc. · Sep 1998
3M QUIKPLUS SYSTEM
K970168 · 3M Company · Feb 1997
TEMPFIL C&B
K964981 · Sybron Dental Specialties, Inc. · Feb 1997
TEMPFIL F
K963786 · Sybron Dental Specialties, Inc. · Nov 1996