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FDA 510(k)

Titan 3 Low Speed Angle Attachments

K-Number: K162397 · 2017-01-19

ApplicantDentalez, Inc.
Decision Date2017-01-19
Product CodeEGS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Titan 3 Low Speed Angle Attachments is a medical device manufactured by Dentalez, Inc.. It received FDA 510(k) clearance on 2017-01-19 under approval number K162397. The device is classified under product code EGS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Titan 3 Low Speed Angle Attachments?

Titan 3 Low Speed Angle Attachments is a medical device that received FDA 510(k) clearance on 2017-01-19. It is manufactured by Dentalez, Inc.. The 510(k) number is K162397.

When was Titan 3 Low Speed Angle Attachments approved by the FDA?

Titan 3 Low Speed Angle Attachments received FDA 510(k) clearance on 2017-01-19, under approval number K162397.

What company makes Titan 3 Low Speed Angle Attachments?

Titan 3 Low Speed Angle Attachments is manufactured by Dentalez, Inc..

What is the FDA product code for Titan 3 Low Speed Angle Attachments?

The FDA product code for Titan 3 Low Speed Angle Attachments is EGS.

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Other Devices by Dentalez, Inc.

K153411430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece K173465Concentrix MX-AC High-Speed Handpiece K192412SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece

Related Devices (Code: EGS)

K162856Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)Bonart Co., Ltd. K171436STRONG Dental HandpiecesSaeshin Precision Co., Ltd. K182892TRAUS Dental HandpiecesSaeshin Precision Co., Ltd. K182999General Cutting Contra HandpieceNakanishi, Inc. K181129STRONG Dental HandpiecesSaeshin Precision Co., Ltd. K202960General Cutting Contra HandpieceNakanishi, 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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