Cleared Traditional

K813550 - HYBRID DENTAL PRODUCT

K813550 is the FDA 510(k) clearance for HYBRID DENTAL PRODUCT by Dentsply Intl.. It is a Class 1 Dental device (product code EBH) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K813550 · Dentsply Intl. · Dental device
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Feb 1982
Decision
65d
Days
Class 1
Risk

K813550 is an FDA 510(k) clearance for the HYBRID DENTAL PRODUCT. Classified as Material, Impression Tray, Resin (product code EBH), Class I - General Controls.

Submitted by Dentsply Intl. (Mchenry, US). The FDA issued a Cleared decision on February 24, 1982 after a review of 65 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 Dentsply Intl. devices

Submission Details

510(k) Number K813550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1981
Decision Date February 24, 1982
Days to Decision 65 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
62d faster than avg
Panel avg: 127d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 13
Devices cleared under the same product code (EBH) and FDA review panel - the closest regulatory comparables to K813550.
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
P-10 POSTERIOR FILLING MATERIAL
K802751 · 3M Company · Nov 1980
CUTTER TRAY-ACRYLIC FOR IMP TRAYS
K760754 · Cutter Laboratories, Inc. · Oct 1976