Cleared Traditional

K181331 - JUVORA Oyster White Dental Disc

K181331 is an FDA 510(k) clearance for JUVORA Oyster White Dental Disc, manufactured by Juvora, Ltd.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K181331 · Juvora, Ltd. · Dental device
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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.

View all Juvora, Ltd. devices

FDA 510(k) Submission Details - K181331

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 127d · This submission: 214d
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 157
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