(175 days)
The U-Type Contra Angles and U-Type Sectional Contra Angles are used to mount on U-Type Nose Attachments and powered by either low speed air motors or electric micro motors. These U-Types are intended for removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth.
U-Type contra angles and U-Type sectional contra angles are used to mount on U-Type Nose Attachments and powered by either low speed air motors or low speed electric motors. These U-Type Contra Angle Attachments are gear 1:1 to the low speed air motors or low speed electrical motors. As results, they transmit the same speed and torque from the connected air motors or electric motors.
This document is a 510(k) Premarket Notification for Henry Schein/Handpiece Headquarters U-Type Contra Angles and U-Type Sectional Contra Angles. The primary purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a numerical or target performance format. Instead, the demonstration of equivalence is based on a direct comparison of technological characteristics and performance (specifically heat generation and speed capabilities) between the new device and the predicate device. The "conclusion" section states that the non-clinical tests did not raise any safety or efficacy concerns and that the device is substantially equivalent based on these comparisons.
The following table summarizes the comparative performance presented in Attachment 8 (H1-Summary table of comparing the technological characteristics between the subjects to predicate devices):
| Metric/Characteristic | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Henry Schein/Handpiece Headquarters U-TYPE contra angles) | Conclusion |
|---|---|---|---|
| Indications for Use | ND U-type prophylaxis angles: used to mount on U-type nose attachment, powered by low speed air motor or electric micro motor for hygiene dentistry work. Autoclavable. | U-Type Contra Angles and U-Type Sectional contra angles: used to mount on U-Type Nose Attachments, powered by low speed air motors or electric micro motors. Intended for removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth. | Similar (The new device explicitly lists broader applications beyond "hygiene dentistry work," but the overall function of mounting to a U-type nose attachment and being powered by low-speed motors for dental procedures remains the same. The document implies no new safety/effectiveness concerns despite the broader listed uses.) |
| Technical Characteristic | |||
| Body length (U-Type Contra Angle 40,000 rpm & 20,000 rpm) | 3.117" (Model DC-10L) | 3.114" | Similar |
| Weight (U-Type Contra Angle 40,000 rpm & 20,000 rpm) | 29.9g (Model DC-10L) | 29.4g | Similar |
| Bearing type (U-Type Contra Angle 40,000 rpm & 20,000 rpm) | Phosphor Bronze bushing bearings (Model DC-10L) | Precision ball bearings | Performance Better (Precision ball bearings can perform better and have less friction (less heat generating) compared to Phosphor Bronze bushing bearings.) |
| Speed range (U-Type Contra Angle 40,000 rpm & 20,000 rpm) | 0-15,000 rpm (Model DC-10L) | 0-40,000 rpm | Higher Speed Capability (Precision ball bearing can handle higher speed.) |
| Heat generate after 5 mins free run (U-Type Contra Angle 40,000 rpm & 20,000 rpm) | From 21 °C to 29.5°C (Model DC-10L) | From 21 °C to 26°C | Similar |
| Body length (U-Type Contra Angle Sectional 40,000 rpm & 20,000 rpm) | 3.110" (Model DC-20L) | 3.100" | Similar |
| Weight (U-Type Contra Angle Sectional 40,000 rpm & 20,000 rpm) | 35.0g (Model DC-20L) | 32.9g | Similar |
| Bearing type (U-Type Contra Angle Sectional 40,000 rpm & 20,000 rpm) | Phosphor Bronze bushing bearings (Model DC-20L) | Precision ball bearings | Performance Better (Precision ball bearings can perform better and have less friction (less heat generating) compared to Phosphor Bronze bushing bearings.) |
| Speed range (U-Type Contra Angle Sectional 40,000 rpm & 20,000 rpm) | 0-20,000 rpm (Model DC-20L) | 0-40,000 rpm | Higher Speed Capability (Precision ball bearing can handle higher speed.) |
| Heat generate after 5 mins free run (U-Type Contra Angle Sectional 40,000 rpm & 20,000 rpm) | From 21 °C to 29°C (Model DC-20L) | From 21 °C to 27°C | Similar |
| Body length (U-Type Contra Angle Friction Grip 20,000 rpm) | 3.14" (Model DC-10FG) | 3.14" | Identical |
| Weight (U-Type Contra Angle Friction Grip 20,000 rpm) | 30.4g (Model DC-10FG) | 31.16g | Similar |
| Bearing type (U-Type Contra Angle Friction Grip 20,000 rpm) | Phosphor Bronze bushing bearings (Model DC-10FG) | Precision ball bearings | Performance Better (Precision ball bearings can perform better and have less friction (less heat generating) compared to Phosphor Bronze bushing bearings.) |
| Speed range (U-Type Contra Angle Friction Grip 20,000 rpm) | 0-15,000 rpm (Model DC-10FG) | 0-20,000 rpm | Higher Speed Capability (Precision ball bearing can handle higher speed.) |
| Heat generate after 5 mins free run (U-Type Contra Angle Friction Grip 20,000 rpm) | From 21 °C to 29.7°C (Model DC-10FG) | From 21 °C to 29.7°C | Identical |
| Body length (U-Type Sectional Contra Angle Friction Grip 20,000 rpm) | 3.15" (Model DC-20FG) | 3.14" | Similar |
| Weight (U-Type Sectional Contra Angle Friction Grip 20,000 rpm) | 31.2g (Model DC-20FG) | 32.7g | Similar |
| Bearing type (U-Type Sectional Contra Angle Friction Grip 20,000 rpm) | Phosphor Bronze bushing bearings (Model DC-20FG) | Precision ball bearings | Performance Better (Precision ball bearings can perform better and have less friction (less heat generating) compared to Phosphor Bronze bushing bearings.) |
| Speed range (U-Type Sectional Contra Angle Friction Grip 20,000 rpm) | 0-15,000 rpm (Model DC-20FG) | 0-20,000 rpm | Higher Speed Capability (Precision ball bearing can handle higher speed.) |
| Heat generate after 5 mins free run (U-Type Sectional Contra Angle Friction Grip 20,000 rpm) | From 21 °C to 28.1°C (Model DC-20FG) | From 21 °C to 28.1°C | Identical |
| Other characteristics (Speed ratio, Attachments, Chuck type, Mount, Patient contact surfaces) | All identical to predicate devices. | All identical to predicate devices. | Identical |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the numerical sample size for the test set used in the "in-house" comparison testing. It simply refers to "these U-type contra angles" and "predicate devices."
- Data Provenance: The testing was conducted "in house per ISO 7785-2:1995 (section 7 of this 510(k))." This indicates the data was generated internally by the manufacturer, rather than being from a specific country of origin or being retrospective/prospective clinical data involving patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided in the document. The study is a benchtop comparative performance study of mechanical devices, not a clinical study requiring expert interpretation of medical images or patient outcomes.
4. Adjudication method for the test set:
Not applicable. This was a direct comparative measurement of physical characteristics and performance based on a standard (ISO 7785-2:1995). No adjudication method is described or required for this type of test.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a 510(k) submission for dental handpiece attachments, which are mechanical devices, not AI/software as a medical device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is about mechanical dental devices, not an algorithm.
7. The type of ground truth used:
The "ground truth" for this engineering comparison study was established by objective physical measurements based on the requirements of ISO 7785-2:1995, which pertains to dental handpieces. The predicate device's characteristics and performance values served as the benchmark for comparison.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI-based device, so there is no training set.
9. How the ground truth for the training set was established:
Not applicable. There is no training set.
§ 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.