Cleared Traditional

K210473 - Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K210473 · Imicryl Dis Malzemeleri Sanayi VE Ticaret AS · Dental device
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Nov 2021
Decision
258d
Days
Class 2
Risk

K210473 is an FDA 510(k) clearance for the Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF,.... Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Imicryl Dis Malzemeleri Sanayi VE Ticaret AS (Konya, TR). The FDA issued a Cleared decision on November 2, 2021 after a review of 258 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 Imicryl Dis Malzemeleri Sanayi VE Ticaret AS devices

Submission Details

510(k) Number K210473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2021
Decision Date November 02, 2021
Days to Decision 258 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 127d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 503
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