Cleared Traditional

Apex Flex (K250617) - FDA 510(k) Clearance

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

K250617 · Sprintray, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
60d
Days
Class 2
Risk

K250617 is an FDA 510(k) clearance for the Apex Flex. 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 April 29, 2025 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sprintray, Inc. devices

Submission Details

510(k) Number K250617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2025
Decision Date April 29, 2025
Days to Decision 60 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
67d faster than avg
Panel avg: 127d · This submission: 60d
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 K250617.
Flexible Partial Resin
K250302 · Prismatik Dentalcraft, Inc. · Jun 2025
Partial Flex
K242897 · Clemde SA DE CV · Jun 2025
FP3D
K250489 · Keystone Industries · May 2025
Asiga DentaBASE
K243356 · Asiga Pty, Ltd. · Apr 2025
Denture Base Resin DT20
K250946 · Hangzhou SHINING3D Dental Technology Co., Ltd. · Mar 2025
Denture Base
K243103 · Riton 3D Technology Co., Ltd. · Dec 2024