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Insight Dental System

by Insight Dental System

510(k) K170211

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK170211 Date27 Apr 2017ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DZE
Device Class
Class II
Regulation
21 CFR Part 872.3640
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Insight Dental System is a dental implant device designed for use in oral and maxillofacial surgery. It is classified under the product code DZE, indicating its application in dental procedures, and is intended for the placement of dental implants within the jawbone.

This system is supplied as a sterile, single-use device, ensuring infection control and patient safety. It is regulated under FDA 510(k) clearance (K170211) and is intended for use in clinical settings by trained dental professionals. The system includes all necessary tools and components for implant placement, adhering to dental advisory committee standards (DE).

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of dental procedures is the Insight Dental System intended for, and who should use it?

    The Insight Dental System is specifically designed for oral and maxillofacial surgery, particularly for the placement of dental implants within the jawbone. It is intended for use in clinical settings by trained dental professionals, such as oral surgeons or periodontists, who specialize in implantology.

  • Is the Insight Dental System reusable or single-use, and how does this affect infection control?

    The Insight Dental System is supplied as a sterile, single-use device, which eliminates the risk of cross-contamination between patients. This design ensures optimal infection control and patient safety, aligning with best practices in dental implantology.

  • How is the system regulated, and what does the FDA 510(k) clearance (K170211) mean for its use?

    The Insight Dental System holds FDA 510(k) clearance (K170211), meaning it has been determined to be *substantially equivalent* to a legally marketed device already on the market. This clearance confirms that the system meets FDA safety and effectiveness requirements for dental implant placement under product code DZE, ensuring it can be legally used in clinical practice in the U.S.

  • Does the system include all necessary tools for dental implant placement, or are additional components required?

    Yes, the Insight Dental System is supplied as a complete kit, including all necessary tools and components required for dental implant placement. This ensures clinicians have everything needed for the procedure without needing to source additional items separately.