(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.
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510(k) ~ "MontBlanc" Surgical Contra-angle and Straight Handpiece anthogyr K111532
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
1. GENERAL INFORMATION
| Submitter | ANTHOGYR (Registration number 8020776) | ||||
|---|---|---|---|---|---|
| 2237 avenue André Lasquin | |||||
| 74700 SALLANCHES FRANCE | |||||
| Phone: 33(0)4 50 58 02 37 Fax: 33(0)4 50 93 78 60 | |||||
| Web : www.anthogyr.com | |||||
| Contacts | Sabine BRAYETTE (QUALITY ENGINEER IN CHARGE OFREGULATORY AFFAIRS) | ||||
| sabine.brayette.prod@anthogyr.com | |||||
| Trade Names | MontBlanc Surgical contra-angle handpiece and straighthandpiece | ||||
| Legally marketedpredicate 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) | |||||
| Classification Name | Dental handpieces and accessories | ||||
| Class | I | ||||
| Product Code | EGS | ||||
| CFR section | 872.4200 | ||||
| Intended Use | Indications are very widespread in the field ofimplantology and surgery. The mentioned handpieces havebeen 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 |
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K1115352
510(k) – "MontBlanc" Surgical Contra-angle and Straight Handpiece anthogyr K111532
| jaw, preprosthetic surgical osteoplasty, sequestrum |
|---|
| removal, fenestration on the alveolar appendix, apical |
| ventilation, bone osteoplasty, bone smoothing. |
2. INTENDED USE
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.
3. DEVICE DESCRIPTION
| Reference | Contra-angle handpiece | Straight handpiece | ||||
|---|---|---|---|---|---|---|
| 12200X | 12200XL | 12200XLED | 12400X | 12400XLED | ||
| Reduction / multiplicationrate | 1 : 3 | 1 :1 | ||||
| Colour code | Orange | blue | ||||
| Weight (g) | 98 | 125 | ||||
| Light | NO | OPTIC FIBER | LED | NO | LED | |
| Motor connectionstandard | ISO 3964 | ISO 3964(type Intra-Matic Lux) | ISO 3964(type Intra-Matic Lux withanthogyrconnexionsystem) | ISO 3964 | ISO 3964(type Intra-Matic Luxwithanthogyrconnexionsystem) | |
| Maximum motor speed(rpm) | 40 000 | |||||
| Tool type according to NFEN ISO 1797-1 | Type 3 | Type 1 ou 2 |
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510(k) - "MontBlanc" Surgical Contra-angle and Straight Handpiece anthogyr K111532
| Reference | Contra-angle handpiece | Straight handpiece | ||||
|---|---|---|---|---|---|---|
| 12200X | 12200XL | 12200XLED | 12400X | 12400XLED | ||
| Diameter of tools (mm)according to NF EN ISO1797-1 | 1.60 | 2.35 | ||||
| Maximum lengthrecommended byAnthogyr (mm) | 25 * | 65 * | ||||
| Maximum diameter of theactive part of the toolrecommended byAnthogyr (mm) | 2 * | 10 * | ||||
| Water spray outputaccording to ISO 7785-2(ml/min) | > 50 |
(*) Suggested values. If using longer and wider diameter rotary instruments, the user is responsible for the correct choice of the operating conditions to prevent any risk to the patient or to a third person.
4. PERFORMANCE DATA
MontBlanc Surgical contra-angle handpiece and straight handpiece conform to the following FDA recognized Consensus standards:
- ✓ ISO 15223-1 (2007) *Medical devices Symbols to be used with medical device labels, labeling and information to be supplied" (Recognition number 5-31)
- ✔ ISO 7785-2 (1998) "Dental Handpieces Part 2: Straight and geared angle handpieces" (Recognition number 4-76)
- √ ISO 3964 (1982) *Dental Handpieces Coupling dimensions" (Recognition List Number: 003 Effective Date: 05/03/1999)
- V ISO 7405 Second edition 2008-12-15 "Dentistry Evaluation of biocompatibility of medical devices used in dentistry" (Recognition List Number : 022)
In addition, MontBlanc Surgical contra-angle handpiece and straight handpiece conform to the following standards:
- √ ISO 14971 (2007) *Medical devices Application of risk management to medical devices" (Recognition number : 5-40)
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510(k) - "MontBlanc" Surgical Contra-angle and Straight Handpiece anthogyr K111532
-
ISO 13485 (1996) "Medical devices - Particular requirements for the application of the ISO 9001"
-
NF EN ISO 1797-1 (1995) "Dental rotatory instruments - Shanks - Par 1: Shanks made of metal"
-
NF EN I50 17664 (2004) « Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices »
5. SUBSTANTIAL EQUIVALENCE
The ANTHOGYR MontBlanc Surgical contra-angle handpiece have the same fundamental scientific technology, operating principle as ANTHOGYR Contra-angles (K090676).
The ANTHOGYR MontBlanc Surgical contra-angle handpiece and straight handpiece have the same fundamental scientific technology, operating principle and intended use as W&H contra-angle handpiece and straight handpiece legally marketed (K011061).
The ANTHOGYR MontBlanc Surgical straight handpiece have fundamental scientific technology as ANTHOGYR Contra-anqles (K040674),
MontBlanc Surgical contra-angle handpiece and straight handpiece have the same fundamental scientific technology, operating principle and intended use as predicate devices.
Summary preparation date: September, 15th 2011
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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of a caduceus, which is a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and wings at the top.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Sabine Brayette Quality Engineer In Charge Of Regulatory Affairs Anthogyr Sas 2237 Avenue Andre Lasquin Sallanches France 74700
OCT - 7 2011
Re: K111532
Trade/Device Name: MontBlanc Surgical Contra-Angle Handpiece and Straight Handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: 1 Product Code: EGS Dated: September 28, 2011 Received: September 30. 2011
Dear Ms. Brayette:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Bravette
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.ida.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
anthogyr
KIII532 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: MontBlanc Surgical contra-angle handpiece and straight handpiece
Indications for Use:
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.q. 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.
AND/OR
Prescription Use_ (Part 21 CFR 801 Subpart D) Over-The-Counter Use_ (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K111532
§ 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.