Cleared Traditional

Riva Cem Automix (K214118) - FDA 510(k) Clearance

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

K214118 · Sdi Limited · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
243d
Days
Class 2
Risk

K214118 is an FDA 510(k) clearance for the Riva Cem Automix. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Sdi Limited (Bayswater, AU). The FDA issued a Cleared decision on August 30, 2022 after a review of 243 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 Sdi Limited devices

Submission Details

510(k) Number K214118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2021
Decision Date August 30, 2022
Days to Decision 243 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
116d slower than avg
Panel avg: 127d · This submission: 243d
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 Peers - EMA Cement, Dental

All 135
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K214118.
Dia-Cem
K231552 · DiaDent Group International · Jul 2023
EsCem
K214076 · Spident Co., Ltd. · Dec 2022
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K222253 · Shofu Dental Corporation · Sep 2022
Bifix Hybrid Abutment Cement
K220640 · Voco GmbH · Aug 2022
NOVA RESIN dual cure, self adhesive resin cement
K213609 · Imicryl Dis Malzemeleri Sanayi VE Ticaret AS · Aug 2022
DeltaFil, DeltaFil Conditioner
K213201 · Dmg Chemisch Pharmazeutische Fabrik GmbH · Jun 2022