Cleared Traditional

K901077 - PRELUDE (TEMPORARY CROWN AND BRIDGE CEM...

K901077 is the FDA 510(k) clearance for PRELUDE (TEMPORARY CROWN AND BRIDGE CEM... by Scientific Pharmaceuticals, Inc.. It is a Class 2 Dental device (product code EBG) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K901077 · Scientific Pharmaceuticals, Inc. · Dental device
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May 1990
Decision
83d
Days
Class 2
Risk

K901077 is an FDA 510(k) clearance for the PRELUDE (TEMPORARY CROWN AND BRIDGE CEMENT). Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Scientific Pharmaceuticals, Inc. (Duarte, US). The FDA issued a Cleared decision on May 29, 1990 after a review of 83 days - a notably fast clearance 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: 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 Scientific Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K901077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1990
Decision Date May 29, 1990
Days to Decision 83 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
44d faster than avg
Panel avg: 127d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 98
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K901077.
PALAVIT 55 AND DENTACOLOR CONNECTOR
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DENTALON PLUS
K903317 · Kulzer, Inc. · Aug 1990
PROTEMP II
K900436 · Espe GmbH (Us) · Mar 1990
CAVIT-W
K875133 · Espe GmbH (Us) · Mar 1988
MAR BOND
K875145 · Reliance Orthodontic Products, Inc. · Feb 1988