Cleared Traditional

SprintRay High Impact Denture Base (K221678) - FDA 510(k) Clearance

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

K221678 · Sprintray, Inc. · Dental device
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Nov 2022
Decision
154d
Days
Class 2
Risk

K221678 is an FDA 510(k) clearance for the SprintRay High Impact Denture Base. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Sprintray, Inc. (Los Angeles, US). The FDA issued a Cleared decision on November 10, 2022 after a review of 154 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 Sprintray, Inc. devices

Submission Details

510(k) Number K221678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2022
Decision Date November 10, 2022
Days to Decision 154 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
27d slower than avg
Panel avg: 127d · This submission: 154d
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 K221678.
ACRIFIX
K230341 · Deltamed GmbH · Apr 2023
Denture Base Resin
K230115 · Aidite (Qinhuangdao) Technology Co., Ltd. · Mar 2023
Dentca Base Premium, Dentca Base Hi-Impact
K220042 · Dentca, Inc. · Nov 2022
V-Print dentbase
K220236 · Voco GmbH · Sep 2022
SprintRay Denture Base
K220979 · Sprintray, Inc. · Sep 2022
Denture Base Polymers
K220680 · Shandong Huge Dental Material Corporation · Aug 2022