Cleared Traditional

K894644 - CROWN AND BRIDGE DENTAL RESTORATIVE COM...

K894644 is an FDA 510(k) clearance for CROWN AND BRIDGE DENTAL RESTORATIVE COM..., manufactured by Jeneric/Pentron, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K894644 · Jeneric/Pentron, Inc. · Dental device
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Oct 1989
Decision
88d
Days
Class 2
Risk

K894644 is an FDA 510(k) clearance for the CROWN AND BRIDGE DENTAL RESTORATIVE COMPOSITE SYST. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on October 20, 1989 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Jeneric/Pentron, Inc. devices

FDA 510(k) Submission Details - K894644

510(k) Number K894644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1989
Decision Date October 20, 1989
Days to Decision 88 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
39d faster than avg
Panel avg: 127d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 645
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K894644.
DENTAL CORE MATERIAL
K896564 · Dentsply Intl. · Feb 1990
ENAMEL PREP ENAMEL ETCHANT (EMAIL-PREPARATOR GS)
K896132 · Ivoclar North America, Inc. · Jan 1990
CRYSTALLINE C2 AND CRYSTALLINE L3
K894890 · Confi-Dental Products Co. · Oct 1989
KULZER ADHESIVE CEMENT
K892455 · Kulzer, Inc. · Jun 1989
KULZER INLAY SYSTEM
K892454 · Kulzer, Inc. · Jun 1989
ESPE TULUX-CEM
K891020 · Espe GmbH (Us) · May 1989