Cleared Traditional

K853093 - PSP TEMP - TRAY

K853093 is an FDA 510(k) clearance for PSP TEMP - TRAY, manufactured by Psp Dental Co., Ltd.. The device is a Class 1 Dental device with product code EBH cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K853093 · Psp Dental Co., Ltd. · Dental device
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Sep 1985
Decision
45d
Days
Class 1
Risk

K853093 is an FDA 510(k) clearance for the PSP TEMP - TRAY. Classified as Material, Impression Tray, Resin (product code EBH), Class I - General Controls.

Submitted by Psp Dental Co., Ltd. (Belvedere, Kent, GB). The FDA issued a Cleared decision on September 6, 1985 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3670 - 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 Psp Dental Co., Ltd. devices

FDA 510(k) Submission Details - K853093

510(k) Number K853093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1985
Decision Date September 06, 1985
Days to Decision 45 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 128d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

EBH Device Classification - Class 1, General Controls

Product Code EBH Material, Impression Tray, Resin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3670
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EBH Material, Impression Tray, Resin

All 15
Devices cleared under the same product code (EBH) and FDA review panel - the closest regulatory comparables to K853093.
IMPREGUM F ADHESIVE
K875257 · Espe GmbH (Us) · Mar 1988
IMPRESSION TRAY
K872210 · Dentsply Intl. · Jun 1987
RESIN TRAY IMPRESSION MATERIAL
K854042 · Dentsply Intl. · Nov 1985
VISIBLE LIGHT-CURE COMPOSITE -POLISHABLE
K844471 · Dentsply Intl. · Feb 1985
HYBRID DENTAL PRODUCT
K813550 · Dentsply Intl. · Feb 1982
SR-IVOLEN
K810686 · J. Aderer, Inc. · Apr 1981