FDA 510(k)

Firstar Dental Unit

Numéro K : K231297 · 2025-01-27

Date de décision2025-01-27

Code produitEIA

Comité consultatifDE

DécisionSubstantially Equivalent

Résumé du dispositif

Firstar Dental Unit is the device name listed in this FDA 510(k) record. The listed applicant is Firstar Dental Company. It received FDA 510(k) clearance on 2025-01-27 under 510(k) number K231297. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Firstar Dental Unit?

Firstar Dental Unit is a medical device that received FDA 510(k) clearance on 2025-01-27. The listed applicant is Firstar Dental Company. The 510(k) number is K231297.

When did Firstar Dental Unit receive FDA 510(k) clearance?

Firstar Dental Unit received FDA 510(k) clearance on 2025-01-27, under 510(k) number K231297.

Who is the listed applicant for Firstar Dental Unit?

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

What is the FDA product code for Firstar Dental Unit?

The FDA product code for Firstar Dental Unit is EIA.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Dispositifs connexes (Code : EIA)

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)Lakong Medical Devices Co., Ltd.K251626Midmark Dental Delivery SystemMidmark Corporation K251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair Business K243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, LLC

Source officielle

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