Cleared Traditional

K181331 - JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White (FDA 510(k) Clearance)

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

K181331 · Juvora, Ltd. · Dental device
Dec 2018
Decision
214d
Days
Class 2
Risk

K181331 is an FDA 510(k) clearance for the JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Juvora, Ltd. (Thornton-Clevelys, GB). The FDA issued a Cleared decision on December 21, 2018 after a review of 214 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.

Submission Details

510(k) Number K181331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2018
Decision Date December 21, 2018
Days to Decision 214 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 158d · This submission: 214d
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 17
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K181331.
LuxCreo Flexible Partial Denture Resin
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TERA HARZ Hard Denture (THD-C-500)
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UltraPrint-Dental Denture UV
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Freeprint® denture flex
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DENTURE SOFT EX (Pink set)
K252035 · Kamemizu Chemical Industry Co., Ltd. · Sep 2025
Flexible Partial Resin
K250302 · Prismatik Dentalcraft, Inc. · Jun 2025