(126 days)
Indications are very widespread in the field of implantology and surgery. The mentioned handpieces have been developed especially for the following applications : - MontBlanc Surgical contra-angle handpiece : for e.g. hemisection, wisdom tooth extraction. - MontBlanc Surgical straight handpiece : for e.g. application in the area of the front teeth, root tip resection, bone removal, osteotomy on the upper and lower jaw, preprosthetic surgical osteoplasty, sequestrum removal, fenestration on the alveolar appendix, apical ventilation, bone osteoplasty, bone smoothing.
The device consists of MontBlanc Surgical contra-angle handpieces and straight handpieces with different reduction/multiplication rates, color codes, weights, light options (NO, OPTIC FIBER, LED), motor connection standards (ISO 3964, ISO 3964 (type Intra-Matic Lux), ISO 3964 (type Intra-Matic Lux with anthogyr connexion system)), maximum motor speed, tool types according to NF EN ISO 1797-1, diameter of tools according to NF EN ISO 1797-1, maximum length recommended by Anthogyr, maximum diameter of the active part of the tool recommended by Anthogyr, and water spray output according to ISO 7785-2.
This is not an AI/ML device - hence the information for acceptance criteria and study data does not follow the expected format.
The MontBlanc Surgical Contra-angle and Straight Handpiece is a conventional dental handpiece, and its clearance focuses on demonstrating substantial equivalence to previously marketed devices and conformity to recognized consensus standards rather than AI/ML specific performance metrics.
Here is a summary of the information provided, tailored to the context of this traditional medical device:
Acceptance Criteria and Device Performance
The device demonstrates performance by conforming to several FDA-recognized consensus standards and other relevant standards. "Acceptance criteria" in this context refers to meeting the specifications and requirements outlined in these standards.
| Acceptance Criteria (Relevant Standards) | Reported Device Performance |
|---|---|
| ISO 15223-1 (2007): Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied (Recognition number 5-31) | The MontBlanc Surgical contra-angle handpiece and straight handpiece conform to this standard. This implies that the device's labeling and information use recognized symbols as required, ensuring clear communication of necessary information. |
| ISO 7785-2 (1998): Dental Handpieces - Part 2: Straight and geared angle handpieces (Recognition number 4-76) | The MontBlanc Surgical contra-angle handpiece and straight handpiece conform to this standard. This standard specifies requirements for the physical and performance characteristics of dental handpieces, including aspects like rotational speed, torque, and water spray output. The table in the "DEVICE DESCRIPTION" section provides specific values for: |
- Reduction/multiplication rate: 1:3 (Contra-angle), 1:1 (Straight handpiece)
- Weight: 98g (Contra-angle), 125g (Straight handpiece)
- Light: NO, OPTIC FIBER, LED options
- Motor connection standard: ISO 3964
- Maximum motor speed: 40,000 rpm (Contra-angle)
- Tool type according to NF EN ISO 1797-1: Type 3 (Contra-angle), Type 1 or 2 (Straight handpiece)
- Water spray output according to ISO 7785-2: > 50 ml/min (Contra-angle) |
| ISO 3964 (1982): Dental Handpieces - Coupling dimensions (Recognition List Number: 003) | The MontBlanc Surgical contra-angle handpiece and straight handpiece conform to this standard. This ensures the device's compatibility with standard dental motor connections. |
| ISO 7405 (2008-12-15): Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (Recognition List Number: 022) | The MontBlanc Surgical contra-angle handpiece and straight handpiece conform to this standard. This indicates that the materials used in the device have been evaluated for biocompatibility, minimizing adverse reactions when in contact with tissues. |
| ISO 14971 (2007): Medical devices - Application of risk management to medical devices (Recognition number: 5-40) | The MontBlanc Surgical contra-angle handpiece and straight handpiece conform to this standard. This means a risk management process was applied during the device's development to identify, analyze, evaluate, control, and monitor risks associated with its use. |
| ISO 13485 (1996): Medical devices - Particular requirements for the application of the ISO 9001 | This standard, though not FDA-recognized in the list provided, is also stated as one the device conforms to. It signifies that the manufacturer operates under a quality management system specifically for medical devices. |
| NF EN ISO 1797-1 (1995): Dental rotatory instruments - Shanks - Part 1: Shanks made of metal | This standard specifies requirements for the shanks of dental rotary instruments. The device explicitly references this standard for "Tool type" and "Diameter of tools." |
| NF EN ISO 17664 (2004): Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices | This standard ensures that the manufacturer provides adequate instructions for the sterilization of the device, which is crucial for reusable surgical instruments. |
Study Information (Not Applicable for this type of device)
For a traditional medical device like a dental handpiece, the "study" for 510(k) clearance typically involves demonstrating compliance with recognized standards and substantial equivalence to predicate devices, rather than a clinical study with patients or a separate performance study with a test set of data. Therefore, many of the requested attributes related to AI/ML device studies are not applicable.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. Performance is demonstrated through engineering tests and compliance with standards, not a data-driven test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth as understood in AI/ML is not relevant here. Device performance is measured against engineering specifications.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Device performance is verified against established engineering and safety standards.
- The sample size for the training set: Not applicable. This is not an AI device.
- How the ground truth for the training set was established: Not applicable. This is not an AI device.
Substantial Equivalence: The primary "study" for this device's clearance is the demonstration of substantial equivalence to legally marketed predicate devices:
- ANTHOGYR Contra-angle and Handpiece (K040674)
- ANTHOGYR MontBlanc Contra-angle (K090676)
- WH Surgical contra-angle Handpieces (K011061)
- WH Surgical contra-angle and straight handpiece (K080939)
The manufacturer states that the new MontBlanc handpieces "have the same fundamental scientific technology, operating principle and intended use as predicate devices." This comparison forms the basis of their "performance data" for regulatory submission.
§ 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.