Cleared Traditional

K904034 - TEMPORARY DENTAL CEMENT

K904034 is an FDA 510(k) clearance for TEMPORARY DENTAL CEMENT, manufactured by Medical Device Inspection Co., Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K904034 · Medical Device Inspection Co., Inc. · Dental device
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Dec 1990
Decision
118d
Days
Class 2
Risk

K904034 is an FDA 510(k) clearance for the TEMPORARY DENTAL CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Medical Device Inspection Co., Inc. (Great Neck, US). The FDA issued a Cleared decision on December 27, 1990 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 Medical Device Inspection Co., Inc. devices

FDA 510(k) Submission Details - K904034

510(k) Number K904034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1990
Decision Date December 27, 1990
Days to Decision 118 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 127d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 429
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K904034.
3M LUTING CEMENT, PASTE A AND B
K911842 · 3M Company · Jun 1991
SILICOATER MD
K910719 · Kulzer, Inc. · Apr 1991
TEETHMATE-F
K910424 · Kuraray Co. · Apr 1991
CEMPER
K904024 · Scientific Pharmaceuticals, Inc. · Nov 1990
CHEMFIL II CAPS
K901524 · Dentsply Intl. · Sep 1990
SURGI PAK NE AND COCOMENT EUGENAL FREE PASTE SYST
K902817 · Confi-Dental Products Co. · Aug 1990