Cleared Traditional

K112397 - ORTHO-JET CRYSTAL

K112397 is an FDA 510(k) clearance for ORTHO-JET CRYSTAL, manufactured by Lang Dental Mfg. Co., Inc.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K112397 · Lang Dental Mfg. Co., Inc. · Dental device
Download Printable Device Report (PDF)
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Nov 2011
Decision
77d
Days
Class 2
Risk

K112397 is an FDA 510(k) clearance for the ORTHO-JET CRYSTAL. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Lang Dental Mfg. Co., Inc. (Wheeling, US). The FDA issued a Cleared decision on November 4, 2011 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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 - K112397

510(k) Number K112397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2011
Decision Date November 04, 2011
Days to Decision 77 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 128d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 303
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K112397.
DEFLEX
K113608 · Nuxen S.R.L. · Apr 2012
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K113788 · Nuxen S.R.L. · Mar 2012
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SOFRELINER TOUGH S
K112445 · Tokuyama Dental Corporation · Oct 2011
PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID
K111832 · Heraeus Kulzer, LLC · Sep 2011
JUELL HARD CURE
K111177 · Juell Dental · Sep 2011
K112397 · ORTHO-JET CRYSTAL
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