Cleared Traditional

K964809 - SPETEMP EF

K964809 is an FDA 510(k) clearance for SPETEMP EF, manufactured by Ultradent Products, Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K964809 · Ultradent Products, Inc. · Dental device
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Jan 1997
Decision
34d
Days
Class 2
Risk

K964809 is an FDA 510(k) clearance for the SPETEMP EF. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on January 2, 1997 after a review of 34 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ultradent Products, Inc. devices

FDA 510(k) Submission Details - K964809

510(k) Number K964809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1996
Decision Date January 02, 1997
Days to Decision 34 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
93d faster than avg
Panel avg: 127d · This submission: 34d
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 421
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K964809.
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
HYCEM APLICAP
K963737 · Espe GmbH & Co. Kg. · Nov 1996
CYBER-FIL ALKENOATE CEMENT MULTI-PURPOSE KIT (23900/23905/23910/23915/23920)
K962733 · Union Broach, Div. Moyco Industries, Inc. · Oct 1996
PULPDENT ENDODONTIC POST CEMENT KIT
K962747 · Pulpdent Corp. · Sep 1996