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FDA 510(k)

ULTRASONIC SURGERY

K-Number: K121620 · 2012-12-11

ApplicantDmetec.Co., Ltd.
Decision Date2012-12-11
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULTRASONIC SURGERY is the device name listed in this FDA 510(k) record. The listed applicant is Dmetec.Co., Ltd.. It received FDA 510(k) clearance on 2012-12-11 under 510(k) number K121620. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASONIC SURGERY?

ULTRASONIC SURGERY is a medical device that received FDA 510(k) clearance on 2012-12-11. The listed applicant is Dmetec.Co., Ltd.. The 510(k) number is K121620.

When did ULTRASONIC SURGERY receive FDA 510(k) clearance?

ULTRASONIC SURGERY received FDA 510(k) clearance on 2012-12-11, under 510(k) number K121620.

Who is the listed applicant for ULTRASONIC SURGERY?

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

What is the FDA product code for ULTRASONIC SURGERY?

The FDA product code for ULTRASONIC SURGERY is DZI.

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Other records listing Dmetec.Co., Ltd. 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.

K170104COMPACT S, COMPACT S (LED)K113152ULTRASONIC SURGERY MACHINEK060171CLEANSE S+ ULTRASONIC SCALERK051571SKYLIGHT LED CURING LIGHT

Related Devices (Code: DZI)

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.

K253655Angled Screwdriver MED (M-SD090)W&H Dentalwerk Bürmoos GmbHK253776Implantmed Plus II & Piezomed Plus II ModuleW&H Dentalwerk Buermoos GmbHK254163VarioSurg 4Nakanishi, Inc.K242432MT-BoneMectron S.P.A.K240340Surgical Drive System (Model: ES70, ES90, E8)Guangdong Jinme Medical Technology Co., Ltd.K231087Guided Surgery KitImplant Direct Sybron Manufacturing, LLC

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.

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