Cleared Traditional

K970774 - TEMPOCEM NE (MULTIPLE)

K970774 is an FDA 510(k) clearance for TEMPOCEM NE (MULTIPLE), manufactured by Foremost Dental Mfg., Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K970774 · Foremost Dental Mfg., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
91d
Days
Class 2
Risk

K970774 is an FDA 510(k) clearance for the TEMPOCEM NE (MULTIPLE). Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Foremost Dental Mfg., Inc. (Englewood, US). The FDA issued a Cleared decision on June 3, 1997 after a review of 91 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 Foremost Dental Mfg., Inc. devices

FDA 510(k) Submission Details - K970774

510(k) Number K970774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1997
Decision Date June 03, 1997
Days to Decision 91 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
36d faster than avg
Panel avg: 127d · This submission: 91d
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 431
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K970774.
CIMPAT N
K972485 · Arent, Fox, Kintner, Plotkin & Kahn · Sep 1997
DENTALIS KEZ ENDODONITC SEALER
K971642 · Neodental Chemical Products Co., Ltd. · Jul 1997
HI DENSE TC
K971927 · Shofu Dental Corp. · Jun 1997
TEMPO CEM (MULTIPLE)
K970775 · Foremost Dental Mfg., Inc. · Jun 1997
SPETEMP
K964808 · Ultradent Products, Inc. · Feb 1997
DENTEMP ONE STEP
K964773 · Majestic Drug Co., Inc. · Feb 1997