Cleared Traditional

K221678 - SprintRay High Impact Denture Base

K221678 is an FDA 510(k) clearance for SprintRay High Impact Denture Base, manufactured by Sprintray, Inc.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 154-day FDA review.

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

FDA 510(k) Submission Details - K221678

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.

EBI Device Classification - Class 2, Special Controls

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 156
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