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FDA 510(k)

ZR DENTAL BLOCK

K-Number: K093571 · 2010-03-12

ApplicantAms Co., Ltd.
Decision Date2010-03-12
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZR DENTAL BLOCK is the device name listed in this FDA 510(k) record. The listed applicant is Ams Co., Ltd.. It received FDA 510(k) clearance on 2010-03-12 under 510(k) number K093571. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZR DENTAL BLOCK?

ZR DENTAL BLOCK is a medical device that received FDA 510(k) clearance on 2010-03-12. The listed applicant is Ams Co., Ltd.. The 510(k) number is K093571.

When did ZR DENTAL BLOCK receive FDA 510(k) clearance?

ZR DENTAL BLOCK received FDA 510(k) clearance on 2010-03-12, under 510(k) number K093571.

Who is the listed applicant for ZR DENTAL BLOCK?

The FDA 510(k) record lists Ams Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZR DENTAL BLOCK?

The FDA product code for ZR DENTAL BLOCK is EIH.

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Related Devices (Code: EIH)

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.

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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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