FDA 510(k)

FP3D

K-Number: K250489 · 2025-05-20

Decision Date2025-05-20

Product CodeEBI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

FP3D is the device name listed in this FDA 510(k) record. The listed applicant is Keystone Industries. It received FDA 510(k) clearance on 2025-05-20 under 510(k) number K250489. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FP3D?

FP3D is a medical device that received FDA 510(k) clearance on 2025-05-20. The listed applicant is Keystone Industries. The 510(k) number is K250489.

When did FP3D receive FDA 510(k) clearance?

FP3D received FDA 510(k) clearance on 2025-05-20, under 510(k) number K250489.

Who is the listed applicant for FP3D?

The FDA 510(k) record lists Keystone Industries as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FP3D?

The FDA product code for FP3D is EBI.

Other records listing Keystone Industries as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241089KeyPrint KeyDenture Base K183598KeyPrint KeySplint Soft

Related Devices (Code: EBI)

K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.K260376Denture BaseShandong Huge Dental Material Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.