Cleared Traditional

DeltaFil, DeltaFil Conditioner (K213201) - FDA 510(k) Clearance

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

K213201 · Dmg Chemisch Pharmazeutische Fabrik GmbH · Dental device
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Jun 2022
Decision
245d
Days
Class 2
Risk

K213201 is an FDA 510(k) clearance for the DeltaFil, DeltaFil Conditioner. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Dmg Chemisch Pharmazeutische Fabrik GmbH (Hamburg, DE). The FDA issued a Cleared decision on June 1, 2022 after a review of 245 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 Dmg Chemisch Pharmazeutische Fabrik GmbH devices

Submission Details

510(k) Number K213201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2021
Decision Date June 01, 2022
Days to Decision 245 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
118d slower than avg
Panel avg: 127d · This submission: 245d
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 Consultant

Delphi Medical Device Consulting, Inc.
Pamela Papineau

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 - EMA Cement, Dental

All 153
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K213201.
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