Cleared Traditional

K130654 - CRYSTAL ULTRA

K130654 is an FDA 510(k) clearance for CRYSTAL ULTRA, manufactured by Dental Laboratory Milling Supplies, LLC (Dlms). The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K130654 · Dental Laboratory Milling Supplies, LLC (Dlms) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
196d
Days
Class 2
Risk

K130654 is an FDA 510(k) clearance for the CRYSTAL ULTRA. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Dental Laboratory Milling Supplies, LLC (Dlms) (Scottsdale, US). The FDA issued a Cleared decision on September 24, 2013 after a review of 196 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dental Laboratory Milling Supplies, LLC (Dlms) devices

FDA 510(k) Submission Details - K130654

510(k) Number K130654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2013
Decision Date September 24, 2013
Days to Decision 196 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 127d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EIH Device Classification - Class 2, Special Controls

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 294
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K130654.
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ZENOLUX
K130184 · Wieland Dental + Technik GmbH & Co. KG · May 2013
VINTAGE MP PRESS OVER
K122614 · Shofu Dental Corporation · May 2013