Cleared Traditional

K170375 - Nobilplast Denture Resin

K170375 is the FDA 510(k) clearance for Nobilplast Denture Resin by Cmp Industries, LLC. It is a Class 2 Dental device (product code EBI) cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K170375 · Cmp Industries, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
237d
Days
Class 2
Risk

K170375 is an FDA 510(k) clearance for the Nobilplast Denture Resin. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Cmp Industries, LLC (Albany, US). The FDA issued a Cleared decision on October 2, 2017 after a review of 237 days - an extended review 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: 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 Cmp Industries, LLC devices

Submission Details

510(k) Number K170375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2017
Decision Date October 02, 2017
Days to Decision 237 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
110d slower than avg
Panel avg: 127d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 124
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K170375.
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