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This product is intended for use by dental professionals only. This device generates ultrasonic vibrations intended for use in dental applications such as scaling, periodontal therapy, root canal treatment and cavity preparation.

The Hu-Friedy® brand Symmetry IQ Ultrasonic Scalers are similar to the Ultrasonic Scalers of the predicate device listed above. These devices are intended for use by dental professionals only. These devices generate ultrasonic vibrations intended for use in dental applications such as scaling, periodontal therapy, root canal treatment and cavity preparation. Hu-Friedy will purchase the generators from NSK, Inc. (Nakanishi) and own brand private label the device. The modifications to the Hu-Friedy product are cosmetic in nature and consist mainly of new shape and design to the housing of the control unit. All of the internal electrical and technical specifications are identical to the marketed NSK units. Hu-Friedy currently has a 510k (K053178) approval for the Symmetry line of piezoelectric tips that are compatible with Satelec and NSK piezoelectric ultrasonic scalers. The addition of the Symmetry IQ generators and handpiece will complete our ultrasonic piezo scaling product line. The Symmetry IQ Ultrasonic Scalers have essentially the same design as the predicate device's ultrasonic generators. The Symmetry IQ 2000 series is equivalent to the Varios 150 Lux (Optic), which is an integrated version of the Varios 350 Lux (Optic) to be used in the delivery tray table as a built in system. The Symmetry IO 3000 series is equivalent to the combination of the Varios 550 control unit with the handpiece used in the Varios 350 Lux (Optic). The Symmetry IQ 3000 unit is based on the NSK Varios 560 which is currently pending FDA 510k approval. The addition of a silicone grip to the ultrasonic generator handpiece used in both models is the only significant change and the reason for the new 510k application.

This submission describes the Symmetry IQ Dental Ultrasonic Scaler, a dental device used for various dental applications. The basis of the 510(k) clearance is substantial equivalence to a predicate device, as opposed to a new algorithm-based device requiring extensive performance testing against acceptance criteria.

Therefore, the requested information regarding acceptance criteria, performance studies, expert involvement, and ground truth for an AI/algorithm-based device is not applicable to this 510(k) submission.

The document states that:

• "The modifications to the Hu-Friedy product are cosmetic in nature and consist mainly of new shape and design to the housing of the control unit. All of the internal electrical and technical specifications are identical to the marketed NSK units."
• "The Symmetry IQ Ultrasonic Scalers have essentially the same design as the predicate device's ultrasonic generators."
• The "addition of a silicone grip to the ultrasonic generator handpiece used in both models is the only significant change and the reason for the new 510k application."

The studies mentioned (sterilization study, biocompatibility testing, ISO 22374 life testing) are safety and performance verification tests for the modified components and overall device, rather than comparative effectiveness studies for an AI-driven diagnostic or therapeutic tool.

As such, I cannot populate the table and answer the specific detailed questions as they are designed for performance evaluation of AI/ML software or algorithms, which is not the nature of this device's submission.

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