Cleared Traditional

UniPrime A, UniPrime E, UniPrime E/C (K221033) - FDA 510(k) Clearance

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

K221033 · S&C Polymer Silicon- Und Composite Spezialit?ten GmbH · Dental device
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Jul 2022
Decision
90d
Days
Class 2
Risk

K221033 is an FDA 510(k) clearance for the UniPrime A, UniPrime E, UniPrime E/C. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by S&C Polymer Silicon- Und Composite Spezialit?ten GmbH (Elmshorn, DE). The FDA issued a Cleared decision on July 6, 2022 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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 S&C Polymer Silicon- Und Composite Spezialit?ten GmbH devices

Submission Details

510(k) Number K221033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2022
Decision Date July 06, 2022
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 121
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K221033.
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