Cleared Traditional

K212541 - 3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix (FDA 510(k) Clearance)

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

K212541 · Deltamed GmbH · Dental device
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Jan 2022
Decision
151d
Days
Class 2
Risk

K212541 is an FDA 510(k) clearance for the 3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Deltamed GmbH (Friedberg, DE). The FDA issued a Cleared decision on January 10, 2022 after a review of 151 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 Deltamed GmbH devices

Submission Details

510(k) Number K212541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2021
Decision Date January 10, 2022
Days to Decision 151 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
24d slower than avg
Panel avg: 127d · This submission: 151d
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 Consultant

Cosmedent, Inc.
Gary Chuven

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 327
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K212541.
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