Cleared Traditional

K011706 - FLEXICAST PRIME

K011706 is an FDA 510(k) clearance for FLEXICAST PRIME, manufactured by American Dent-All, Inc.. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K011706 · American Dent-All, Inc. · Dental device
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Aug 2001
Decision
63d
Days
Class 2
Risk

K011706 is an FDA 510(k) clearance for the FLEXICAST PRIME. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by American Dent-All, Inc. (Glendale, US). The FDA issued a Cleared decision on August 6, 2001 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3710 - 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.

FDA 510(k) Submission Details - K011706

510(k) Number K011706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2001
Decision Date August 06, 2001
Days to Decision 63 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 128d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJH Device Classification - Class 2, Special Controls

Product Code EJH Alloy, Metal, Base
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3710
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 - EJH Alloy, Metal, Base

All 151
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K011706.
D.SIGN 15 (DW286 B)
K020898 · Ivoclar Vivadent, Inc. · Mar 2002
PISCES PLUS (DW286 C)
K020183 · Ivoclar Vivadent, Inc. · Mar 2002
XERAFIT
K020062 · Metalor Technologies USA · Feb 2002
SUPREMCAST
K011705 · American Dent-All, Inc. · Aug 2001
D.SIGN 30
K010381 · Ivoclar North America, Inc. · Mar 2001
DURABOND NON-PRECIOUS CERAMIC ALLOY
K010069 · Matech, Inc. · Feb 2001
K011706 · FLEXICAST PRIME
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