Cleared Traditional

K853092 - PSP C & B TEMP

K853092 is an FDA 510(k) clearance for PSP C & B TEMP, manufactured by Psp Dental Co., Ltd.. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K853092 · Psp Dental Co., Ltd. · Dental device
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Apr 1986
Decision
254d
Days
Class 2
Risk

K853092 is an FDA 510(k) clearance for the PSP C & B TEMP. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Psp Dental Co., Ltd. (Belvedere, Kent, GB). The FDA issued a Cleared decision on April 3, 1986 after a review of 254 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 Psp Dental Co., Ltd. devices

FDA 510(k) Submission Details - K853092

510(k) Number K853092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1985
Decision Date April 03, 1986
Days to Decision 254 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 128d · This submission: 254d
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 168
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K853092.
UNIFAST LC
K890829 · G-C Intl. Corp. · Apr 1989
CAVIT-W
K875133 · Espe GmbH (Us) · Mar 1988
MAR BOND
K875145 · Reliance Orthodontic Products, Inc. · Feb 1988
INTEGRITY
K853052 · Dentsply Intl. · Aug 1985
INTERIM TEMP. CROWN & BRIDGE RESIN
K833261 · Coe Laboratories, Inc. · Jan 1984
DENTALON
K831077 · Kulzer, Inc. · Sep 1983