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FDA 510(k)

Oral Surgery System and Accessories

K-Number: K152125 · 2016-08-15

ApplicantBonart Co., Ltd.
Decision Date2016-08-15
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Oral Surgery System and Accessories is a medical device manufactured by Bonart Co., Ltd.. It received FDA 510(k) clearance on 2016-08-15 under approval number K152125. 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 Oral Surgery System and Accessories?

Oral Surgery System and Accessories is a medical device that received FDA 510(k) clearance on 2016-08-15. It is manufactured by Bonart Co., Ltd.. The 510(k) number is K152125.

When was Oral Surgery System and Accessories approved by the FDA?

Oral Surgery System and Accessories received FDA 510(k) clearance on 2016-08-15, under approval number K152125.

What company makes Oral Surgery System and Accessories?

Oral Surgery System and Accessories is manufactured by Bonart Co., Ltd..

What is the FDA product code for Oral Surgery System and Accessories?

The FDA product code for Oral Surgery System and Accessories is DZI.

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) PMID: 40866856 Prognostic value of nutritional risk assessment indices in patients with digestive system tumors. BMC cancer (2025) PMID: 40624055 Establishment of a clinical workflow for in vivo Raman spectroscopy during head and neck cancer surgery. Scientific reports (2025)

Other Devices by Bonart Co., Ltd.

K162856Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)

Related Devices (Code: DZI)

K172137PIEZOTOME CUBESatelec - Acteon Group K171326Piezosurgery WhiteMectron S.P.A. K171958PIEZOSURGERY TOUCH, PIEZOSURGERY WHITEMectron S.P.A. K192561TRAUS SUS20Saeshin Precision Co., Ltd. K200265Surgical DrillsImplant Direct Sybron Manufacturing, LLC K192033Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad TipBennett Jacoby, Dds, Ms, Inc.

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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