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FDA 510(k)

P50 Series Dental Operative Unit and Accessories

K-Number: K171872 · 2018-04-26

ApplicantPelton & Crane
Decision Date2018-04-26
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

P50 Series Dental Operative Unit and Accessories is a medical device manufactured by Pelton & Crane. It received FDA 510(k) clearance on 2018-04-26 under approval number K171872. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P50 Series Dental Operative Unit and Accessories?

P50 Series Dental Operative Unit and Accessories is a medical device that received FDA 510(k) clearance on 2018-04-26. It is manufactured by Pelton & Crane. The 510(k) number is K171872.

When was P50 Series Dental Operative Unit and Accessories approved by the FDA?

P50 Series Dental Operative Unit and Accessories received FDA 510(k) clearance on 2018-04-26, under approval number K171872.

What company makes P50 Series Dental Operative Unit and Accessories?

P50 Series Dental Operative Unit and Accessories is manufactured by Pelton & Crane.

What is the FDA product code for P50 Series Dental Operative Unit and Accessories?

The FDA product code for P50 Series Dental Operative Unit and Accessories is EIA.

Related Clinical Trials

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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.

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