Cleared Traditional

Denture Base Polymers (K220680) - FDA 510(k) Clearance

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

K220680 · Shandong Huge Dental Material Corporation · Dental device
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Aug 2022
Decision
157d
Days
Class 2
Risk

K220680 is an FDA 510(k) clearance for the Denture Base Polymers. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Shandong Huge Dental Material Corporation (Rizhao City, CN). The FDA issued a Cleared decision on August 12, 2022 after a review of 157 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 Shandong Huge Dental Material Corporation devices

Submission Details

510(k) Number K220680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2022
Decision Date August 12, 2022
Days to Decision 157 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
30d slower than avg
Panel avg: 127d · This submission: 157d
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 Peers - EBI Resin, Denture, Relining, Repairing, Rebasing

All 111
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K220680.
SprintRay High Impact Denture Base
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V-Print dentbase
K220236 · Voco GmbH · Sep 2022
SprintRay Denture Base
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TERA HARZ DENTURE
K222414 · Graphy, Inc. · Aug 2022
Stratasys TrueDent
K220771 · Stratasys, Ltd. · Jul 2022
CediTEC
K220743 · Voco GmbH · Jul 2022