Cleared Traditional

K191591 - BB Base 3D printing resin for denture base

K191591 is an FDA 510(k) clearance for BB Base 3D printing resin for denture base, manufactured by Enlighten Materials Co., Ltd.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 431-day FDA review.

K191591 · Enlighten Materials Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
431d
Days
Class 2
Risk

K191591 is an FDA 510(k) clearance for the BB Base 3D printing resin for denture base. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Enlighten Materials Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on August 18, 2020 after a review of 431 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Enlighten Materials Co., Ltd. devices

FDA 510(k) Submission Details - K191591

510(k) Number K191591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2019
Decision Date August 18, 2020
Days to Decision 431 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
304d slower than avg
Panel avg: 127d · This submission: 431d
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 Consultant

Voler Biotech Consulting CO., Ltd.
Chih-Hao Kao

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EBI Resin, Denture, Relining, Repairing, Rebasing

All 239
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K191591.
FotoDent denture
K200580 · Dreve Dentamid GmbH · Nov 2020
Freeprint denture
K200461 · Detax GmbH & Co. KG · Nov 2020
DIOnavi-Denture
K193623 · Dio Corporation · Oct 2020
Flex Fit
K190790 · Dk Mungyo Corporation · Jul 2020
VITA VIONIC Bond
K191926 · Vita Zanhnfabrik H. Rauter GmbH Co. · Jan 2020
NextDent Denture 3D+
K191497 · Vertex-Dental B.V. · Nov 2019