(245 days)
The STRONG Dental Handpieces. ACL(B)-03C and ACL(B)-03F. are intended for a wide range of dental procedures including:
A. Implant placement, including
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- Preparation of the osteotomy site
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- Bone contouring, osteoplasty
B. Periodontal surgeries
- Bone contouring, osteoplasty
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- Bone contouring & alveoplasty around living teeth
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- Removal of exostosis
C. Bone grafting
- Removal of exostosis
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- Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
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- Harvesting autogen living bone
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- Sinus elevation & grafting of alveolar sockets
D. Removal and sectioning of teeth and teeth bone for e.g. impacted third molars and complicated extractions
- Sinus elevation & grafting of alveolar sockets
The STRONG Dental Handpieces; ACL(B)-03C and ACL(B)-03F are gear driven handheld dental handpieces with Gear Ratio of 1:1. They can be driven by torque adjustable electrical motors for surgery treatment. They are attached to drive via ISO 3964 coupling. The head clamp accepts instrument complying with ISO 1797-1. They have contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.
The provided document describes a 510(k) premarket notification for the STRONG Dental Handpieces (models ACL(B)-03C and ACL(B)-03F). The intention is to demonstrate substantial equivalence to a predicate device (K100192).
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:
Key Takeaway: This submission is for a medical device (dental handpieces), not for an AI/ML powered device. Therefore, many of the typical questions regarding AI/ML study design, such as information about training sets, test sets, ground truth establishment by experts, adjudication methods, and MRMC studies, are not applicable here. The evaluation focuses on non-clinical bench testing and biocompatibility to prove substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Test Standards based on ISO 14457) | STRONG Dental Handpieces (ACL(B)-03C) Performance | STRONG Dental Handpieces (ACL(B)-03F) Performance |
|---|---|---|
| Visual Inspection of General Design (Section 7.2 of handpiece standard) | Complies | Complies |
| Extraction Force (minimum) | ≥ 45 N | ≥ 22 N |
| Reported Extraction Force (Mean) | 51.2 N | 32.2 N |
| Eccentricity (maximum total indicated run-out) | ≤ 0.08 mm | ≤ 0.08 mm |
| Reported Eccentricity (Mean) | 0.014 mm | 0.012 mm |
| Resistance to Sterilizing Procedure (Deterioration) (after 250 cycles of 132°C for 4 min) | No deterioration detected | No deterioration detected |
| Resistance to Sterilizing Procedure (Extraction Force) (after 250 cycles) | > 45 N (Reported: 51.2 N) | > 22 N (Reported: 32.2 N) |
| Resistance to Sterilizing Procedure (Max. Speed) (±10% rpm from initial) | 35,000 rpm (Reported: 35,120 rpm) | 35,000 rpm (Reported: 35,090 rpm) |
| Resistance to Sterilizing Procedure (Noise) |
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.