FDA 510(k)

KeyPrint KeyDenture Base

K-Number: K241089 · 2024-10-24

Decision Date2024-10-24

Product CodeEBI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

KeyPrint KeyDenture Base is the device name listed in this FDA 510(k) record. The listed applicant is Keystone Industries. It received FDA 510(k) clearance on 2024-10-24 under 510(k) number K241089. 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 KeyPrint KeyDenture Base?

KeyPrint KeyDenture Base is a medical device that received FDA 510(k) clearance on 2024-10-24. The listed applicant is Keystone Industries. The 510(k) number is K241089.

When did KeyPrint KeyDenture Base receive FDA 510(k) clearance?

KeyPrint KeyDenture Base received FDA 510(k) clearance on 2024-10-24, under 510(k) number K241089.

Who is the listed applicant for KeyPrint KeyDenture Base?

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 KeyPrint KeyDenture Base?

The FDA product code for KeyPrint KeyDenture Base 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.

K250489FP3D 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

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