(119 days)
No
The document describes a standard electrical-driven dental handpiece with no mention of AI or ML capabilities. The description focuses on mechanical and electrical functions, sterilization, and compatibility with standard dental equipment.
No.
The device is used for mechanical dental procedures such as removing carious material and preparing teeth, rather than for treating a disease or condition itself.
No
Explanation: The device is described as a dental handpiece intended for the removal of carious material, reducing hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, restorations, and polishing teeth. These are all interventional or treatment procedures, not diagnostic ones.
No
The device description explicitly states the devices are "electrical-powered handpieces" and describes physical components like tubes, electrical motors, and connections, indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for physical procedures on teeth (removing material, preparing cavities, etc.). This is a direct intervention on the patient's body.
- Device Description: The description details a mechanical device (handpiece) that uses rotary instruments for dental procedures. It talks about power, cooling, and sterilization, all characteristic of a surgical or procedural tool.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are used in vitro (outside the body) to diagnose or provide information about a disease or condition.
This device falls under the category of a dental surgical or procedural instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SMARTmatic handpieces are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.
Product codes
EFA
Device Description
The SMARTmatic electrical-driven handpieces listed in the table below are dental handpieces for the use by a trained professional in the field of general dentistry. The devices are electrical-powered handpieces that are reusable and ergonomically shaped. The devices can be sterilized by the steam autoclave method. Through the tube and the electrical motor connected to a dental unit, the SMARTmatic handpieces equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) receive the energy for the gear, the cooling water and air for cutting treatment. Dental burs and other attachments will be used with the SMARTmatic handpieces per ISO 1797-1:2011 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth/teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professional in the field of general dentistry.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance bench testing according to international standards for dental handpieces and accessories (handpiece, belt and/or gear driven) has been conducted to determine conformance. Biocompatibility and sterilization studies has been completed for the applicable components. Hence the SMARTmatic demonstrates substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 17, 2017
Kaltenbach & Voigt GmbH Stefan Trampler Director Regulatory Affairs Bismarckring 39 Biberach, 88400 GERMANY
Re: K163239 Trade/Device Name: SMARTmatic Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EFA Dated: February 14, 2017 Received: February 15, 2017
Dear Stefan Trampler:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K163239
Device Name SMARTmatic
Indications for Use (Describe)
The SMARTmatic handpieces are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
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Image /page/3/Picture/0 description: The image features the KaVo Dental Excellence logo. The logo consists of the text "KaVo. Dental Excellence" in a simple font. To the right of the text is a stylized graphic, possibly representing dental tools or abstract shapes, rendered in a metallic blue color.
Section V - 510(k) Summary
Submitter:
Kaltenbach & Voigt GmbH Bismarckring 39 88400 Biberach Stefan Trampler - Contact Person 49 (7351) 56 3515 - Phone number +49 (7351) 56 7 3515 - Facsimile
Date Summary Prepared: February 14, 2017
Device Name:
- Trade Name SMARTmatic .
- Common Name Handpiece, belt and/or gear driven, dental ●
- Classification Name - Dental handpiece and accessories, per 21 CFR § 872.4200
- . Device Class - Class I
- Product Code EFA ●
Devices for Which Substantial Equivalence is Claimed:
MASTERmatic LUX (K143465) marketed by Kaltenbach & Voigt GmbH.
- Trade Name MASTERmatic LUX ●
- Common Name Handpiece, belt and/or gear driven, dental ●
- Classification Name Dental Handpiece and Accessories, per 21 CFR & 872.4200 ●
- Device Class - Class I
- Product Code EFA ●
Device Description:
The SMARTmatic electrical-driven handpieces listed in the table below are dental handpieces for the use by a trained professional in the field of general dentistry. The devices are electricalpowered handpieces that are reusable and ergonomically shaped. The devices can be sterilized by the steam autoclave method. Through the tube and the electrical motor connected to a dental unit, the SMARTmatic handpieces equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) receive the energy for the gear, the cooling water and air for cutting treatment. Dental burs and other attachments will be used with the SMARTmatic handpieces per ISO 1797-1:2011 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals).
| Device | Detailed Description |
|---|---|
| SMARTmatic S10 | This model attaches to a dental motor according to ISO |
| 14457 with coupling per ISO 3964 and represents a straight | |
| handpiece for the use of dental burs and other attachments | |
| according to ISO 1797-1. | |
| SMARTmatic S10 K | This model attaches to a dental motor according to ISO |
| 14457 with coupling per ISO 3964 and represents a straight | |
| handpiece with a reduced diameter at the back of the | |
| handpiece (K) for the use of dental burs and other | |
| attachments according to ISO 1797-1. | |
| SMARTmatic S10 S | This model attaches to a dental motor according to ISO |
| 14457 with coupling per ISO 3964 and represents a straight | |
| handpiece with external spray (S) for the use of dental burs | |
| and other attachments according to ISO 1797-1. | |
| SMARTmatic PROPHY S19 | This model attaches to a dental motor according to ISO |
| 14457 with coupling per ISO 3964 and represents a straight | |
| handpiece for the use of prophylaxis heads with a Doriot | |
| connector according to ISO 14457. | |
| SMARTmatic PROPHY S19 K | This model attaches to a dental motor according to ISO |
| 14457 with coupling per ISO 3964 and represents a straight | |
| handpiece with a reduced diameter at the back of the | |
| handpiece (K) for the use of prophylaxis heads with a Doriot | |
| connector according to ISO 14457. | |
| SMARTmatic S20 | This model attaches to a dental motor according to ISO |
| 14457 with coupling per ISO 3964 and represents a contra- | |
| angle handpiece for the use of dental burs and other | |
| attachments according to ISO 1797-1. | |
| SMARTmatic S20 K | This model attaches to a dental motor according to ISO |
| 14457 with coupling per ISO 3964 and represents a contra- | |
| angle handpiece with a reduced diameter at the back (K) of | |
| the handpiece for the use of dental burs and other | |
| attachments according to ISO 1797-1. | |
| SMARTmatic S20 S | This model attaches to a dental motor according to ISO |
| 14457 with coupling per ISO 3964 and represents a contra- | |
| angle handpiece with external spray (S) for the use of dental | |
| burs and other attachments according to ISO 1797-1. | |
| SMARTmatic S80 K | This model attaches to a dental motor according to ISO |
| 14457 with coupling per ISO 3964 and represents a contra- | |
| angle handpiece with a reduced diameter at the back of the | |
| handpiece (K) for the use of dental burs and other | |
| attachments according to ISO 1797-1. | |
| SMARTmatic ENDO S81 | This model attaches to a dental motor according to ISO |
| 14457 with coupling per ISO 3964 and represents a contra- | |
| angle handpiece for the use of dental burs and other | |
| attachments according to ISO 1797-1 and has a ratio of 8:1 | |
| for endodontic purposes. | |
| Elements 8:1 | This model attaches to a dental motor according to ISO |
| 14457 with coupling per ISO 3964 and represents a contra- | |
| angle handpiece for the use of dental burs and other | |
| attachments according to ISO 1797-1 and has a ratio of 8:1. | |
| SMARTmatic ENDO S321 | This model attaches to a dental motor according to ISO |
| 14457 with coupling per ISO 3964 and represents a contra- | |
| angle handpiece for the use of dental burs and other | |
| attachments according to ISO 1797-1 and has a ratio of 32:1 | |
| for endodontic purposes. | |
| SMARTmatic S53 | This model attaches to a dental motor according to ISO |
| 14457 with coupling per ISO 3964 and represents a contra- | |
| angle handpiece for the use of dental burs and other | |
| attachments according to ISO 1797-1 for prophylaxis and | |
| endodontic purposes. | |
| SMARTmatic PROPHY S31 | This model attaches to a dental motor according to ISO |
| 14457 with coupling per ISO 3964 and represents a contra- | |
| angle handpiece for the use of prophy cups or polishing | |
| brushes according to ISO 13295 for support (spindle) type 5. | |
| SMARTmatic PROPHY S31 K | This model attaches to a dental motor according to ISO 14457 with |
| coupling per ISO 3964 and represents a contra-angle handpiece and | |
| has a reduced diameter at the back of the handpiece (K) for the use | |
| of prophy cups or polishing brushes according to ISO 13295 for | |
| support (spindle) type 5. | |
| SMARTmatic PROPHY S33 | This model attaches to a dental motor according to ISO |
| 14457 with coupling per ISO 3964 and represents a contra- | |
| angle handpiece for the use of prophy cups or polishing | |
| brushes according to ISO 13295 for support (spindle) type 5. |
4
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Per the Guidance for Industry and FDA Staff; Bundling Multiple Indications in a Sinqle Submission, dated June 22, 2007, Kaltenbach and Voigt GmbH is bundling the SMARTmatic models listed above as the models do not differ significantly in purpose, design, materials, energy source, function or any other feature related to safety and effectiveness. The device description and intended use are identical for all configuration models. All critical components within the SMARTmatic dental handpieces are common. The minor differences between the models are cosmetic in nature such as straight or contra-angle design, size / shape of the handpiece, with / without external water spray, and bur movement.
The different electrical motors (i.e. INTRAmatic LUX KL 702) utilized with the SMARTmatic handpieces, are registered with the different dental treatment units (K103027 in the case of INTRAmatic LUX KL 702). Based on the INTRAmatic connection that meets the ISO 3964:1982 standard (Dentistry - Coupling dimensions for handpiece connectors), the SMARTmatic handpieces fit with any electrical dental motor which is produced in accordance to this standard. The different electrical motors will not be delivered together with the SMARTmatic handpieces. The electrical motors carry the gear, the gear, the cooling water and air for cutting treatment from the dental treatment unit to the SMARTmatic handpieces.
Accessories:
Additionally, the SMARTmatic handpiece models equipped with external spray will be supplied with a jet needle. The straight handpieces SMARTmatic S10 / S10 K / S10 S are equipped with a drill bit stop and a hook for removal of the drill. Dental burs and other attachments that meets the ISO 1797-1:2011 standard (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals) may be inserted into the chuck system of the SMARTmatic handpieces for applicable cutting operations based on the intended use. The Accessories are for informational purposes only.
Jet Needle:
- Description of the Principle of Operation / Mechanism of Action The Jet Needle is used ● to clean the spray lines of the devices when necessary.
- A description of proposed conditions of use / How used with the SMARTmatic The . operator will use the Jet Needle by inserting it into the water line to uncloq any blockage.
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Drill Bit Stop (Bur Stop) (SMARTmatic S10 / S10 K / S10 S):
- Description of the Principle of Operation / Mechanism of Action The Drill Bit Stop (Bur ● Stop) is used when using contra-angle burs in a straight handpiece.
- . A description of proposed conditions of use / How used with the SMARTmatic – The operator will open the handpiece chuck then insert the bur stop in the chuck. The operator will then press the contra-angle bur onto the bur stop and then close the clamping ring making sure that it is firmly seated.
Hook (SMARTmatic S10 / S10 K / S10 S):
- Description of the Principle of Operation / Mechanism of Action The Hook is used by ● the operator when removing the Bur Stop.
- A description of proposed conditions of use / How used with the SMARTmatic When a . contra-angle bur is used that requires a Drill Bit Stop (Bur Stop), the Hook is required to remove the Bur Stop out of the chuck after use.
Mechanism of Action:
The SMARTmatic dental handpieces are electrical-driven handpieces which will be supplied with energy, water and air through the tube and the electrical motor of a dental treatment unit. Based on the speed adjusted in the dental treatment unit the handpiece bur rotates up to 40,000 rom. The SMARTmatic handpieces interact with the patient through a rotating bur with the patient teeth according to the intended use.
Statement of Intended Use:
The SMARTmatic handpieces are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.
Substantial Equivalence:
The SMARTmatic handpieces function in a manner similar to and are intended for the same use as the MASTERmatic LUX handpieces (K143465) marketed by Kaltenbach & Voigt GmbH. The SMARTmatic handpieces are similar to the predicate device (K143465) in that they are dental electrical-driven handpieces for the use by a trained professional in the field of general dentistry. The SMARTmatic handpieces are substantially equivalent in design, application and function to the predicate device (K143465). Both the MASTERmatic LUX handpieces (K143465) and the SMARTmatic handpieces are reusable and ergonomically shaped. The devices can be sterilized by the steam autoclave method. Dental burs and cutters (with straight handpiece shank or with contra-angle shank) according to ISO 1797-1 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals - ISO 1797-1:2011) can be used for both, the SMARTmatic handpieces and the MASTERmatic LUX handpieces (K143465). In addition, both handpiece types, the SMARTmatic handpieces and the MASTERmatic LUX handpieces (K143465) are equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) and receive the energy for the gear, the cooling water and air for cutting treatment through the tube and the specific electrical motor connected to a dental unit as the mechanism of action.
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The SMARTmatic handpieces differ from the MASTERmatic LUX handpieces (K143465) in dimensions, speed range, type of chuck, fiber optics and the supply of spray. The SMARTmatic handpieces are only available with external spray (according to the model). The SMARTmatic handpieces are not available with a fiber optic light system. The speed range of the SMARTmatic handpieces which is up to 40.000 rpm differs from the speed range of the MASTERmatic LUX handpieces (200.000 rpm). Some models of the SMARTmatic handpieces are also available with a different type of chuck. Both devices have small differences in the dimensions (see Table - Summary of the Technological Characteristics).
The performance tests demonstrate that the differences in technological characteristics do not raise different concerns reqarding substantial equivalence to the predicate device. Hence, the SMARTmatic handpieces are substantial equivalent to the MASTERmatic LUX handpieces.
In summary, the SMARTmatic handpieces with the indications for use and intended use described in this submission are substantially equivalent to the MASTERmatic LUX handpieces cleared under K143465. It also satisfies all criteria of substantial equivalence and does not raise new concerns regarding substantial equivalence: (1) Indications for Use, (2) Technological Characteristics and (3) Performance Data. The new device does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is substantial equivalent.
Summary of the Technological Characteristics:
| Descriptive
Information | SMARTmatic | MASTERmatic LUX (K143465)
from Kaltenbach & Voigt GmbH |
|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | | |
| Indications for Use | The SMARTmatic handpieces are
intended for the removal of carious
material, reducing of hard tooth
structure, cavity and crown
preparations, root canal preparations,
removal of fillings, processing and
finishing tooth preparations,
restorations, and for polishing teeth.
They are designed for use by a trained
professional in the field of general
dentistry. | The MASTERmatic LUX handpieces are
intended for the removal of carious
material, reducing of hard tooth
structure, cavity and crown
preparations, root canal preparations,
removal of fillings, processing and
finishing tooth preparations,
restorations, and for polishing teeth.
They are designed for use by a trained
professional in the field of general
dentistry. |
| Device Design | | |
| Functional Principle | Through the micro motor connected
to the dental treatment unit the
straight and contra-angle handpieces
equipped with a handpiece connection
according to ISO 3964 (Dentistry -
Coupling dimensions for handpiece
connectors - ISO 3964:1982) receives
the energy, the cooling water and air
for treatment and the light for
illumination the operating area. | Through the micro motor connected to
the dental treatment unit the straight
and contra-angle handpieces equipped
with a handpiece connection according
to ISO 3964 (Dentistry - Coupling
dimensions for handpiece connectors -
ISO 3964:1982) receives the energy,
the cooling water and air for treatment
and the light for illumination the
operating area. |
| Operational Modes | N/A - Standard | N/A - Standard |
| Air / water ports | No Spray / External Spray | Internal Spray |
| Fiberoptics | Without light system | With built-in light system |
| Dimensions | Head size-Height: Up to 13,6 mm
Head size-Diameter: Up to 9,8 mm
Length: Up to 93,4 mm | Head size-Height: Up to 13,6 mm
Head size-Diameter: Up to 10,2 mm
Length: Up to 95,9 mm |
| Type of chuck | Push Button, Twist-tension Chuck, Snap-on & Screw-in | Push Button, Twist-tension Chuck |
| Coupling Dimensions | Dimensions comply with ISO 3964
(Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) | Dimensions comply with ISO 3964
(Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) |
| Accessories | Jet Needle, Drill Bit Stop (Bur Stop), Hook, Dental Burs and Prophylaxis Heads | Jet Needle, Drill Bit Stop (Bur Stop), Hook and Dental Burs |
| Rotary Instruments | For Burs, Cutters and other attachments (with straight handpiece shank or with contra-angle shank) according to ISO 1797-1 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals - ISO 1797-1:2011). | For Burs, Cutters and other attachments (with straight handpiece shank or with contra-angle shank) according to ISO 1797-1 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals - ISO 1797-1:2011). |
| Composition of Materials | | |
| Direct patient-contacting portions of the device | All materials for the SMARTmatic models are listed in the tables below including chemical composition of the waterlines and the patient-contacting portions of the device. Biocompatible according to ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system - ISO 10993-1:2009) | Biocompatible according to ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system - ISO 10993-1:2009) |
| Indirect patient-contacting portions of the device (water / air lines) | All materials for the SMARTmatic models are listed in the tables below including chemical composition of the waterlines and the patient-contacting portions of the device. Biocompatible according to ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system - ISO 10993-1:2009) | Biocompatible according to ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system - ISO 10993-1:2009) |
| Technical Specifications | | |
| Chuck Design | Push Button, Twist-tension Chuck,
Snap-on & Screw-in | Push Button, Twist-tension Chuck |
| Light Intensity | N/A | 25,000 Lux |
| Bur Retention Force | Min. 22 N (45 N straight handpieces) | Min. 22 N (45 N straight handpieces) |
| Bur Extraction Force | 15N - 52N | 15N - 52N |
| Maximum Air Pressure | 29 psi | 29 psi |
| Maximum Water Pressure | 29 psi | 29 psi |
| Speed Range (RPM's) | Up to 40,000 rpm | Up to 200,000 rpm |
| Conformance Standards (Handpieces and Motors) | ISO 14457 (Dentistry - Handpieces and motors - ISO 14457:2012) | ISO 14457 (Dentistry - Handpieces and motors - ISO 14457:2012) |
| Conformance Standards (Shanks) | ISO 1797-1 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals - ISO 1797-1:2011) | ISO 1797-1 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals - ISO 1797-1:2011) |
| Conformance Standards (Coupling Dimensions) | ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) | ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) |
| Conformance Standards (Hose Connections) | N/A - For air driven handpieces only. | N/A - For air driven handpieces only. |
| Sterilization | Sterilisable according to ISO 17665-1
(Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices on the final, finished device - ISO 17665-1:2006) | Sterilisable according to ISO 17665-1
(Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices on the final, finished device - ISO 17665-1:2006) |
| Lubricant | KaVo QUATTROcare (K071288) | KaVo QUATTROcare (K071288) |
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Non-Clinical Test Data:
Performance bench testing according to international standards for dental handpieces and accessories (handpiece, belt and/or gear driven) has been conducted to determine conformance. Biocompatibility and sterilization studies has been completed for the applicable components. Hence the SMARTmatic demonstrates substantial equivalence.
The performance of the SMARTmatic handpieces has been verified utilizing the following standards:
- ISO 3964 1982-12-00 Dentistry Coupling dimensions for handpiece connectors ●
- . ISO 1797-1 - 2011-08-00 - Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals
- ISO 7405 Second edition 2008-12-15 Dentistry Evaluation of biocompatibility of medical ● devices used in dentistry / ISO 10993-1 - 2009-10-00 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system
- . ISO 14457 - 2012-09-15 - Dentistry - Handpieces and motors
- ISO 17665-1 2006-08-15 Sterilization of health care products Moist heat Part 1: ● Requirements for the development, validation and routine control of a sterilization process for medical devices on the final, finished device
- AAMI ANSI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Comprehensive Guide ● To Steam Sterilization And Sterility Assurance In Health Care Facilities
- . Guidance for Industry and FDA Staff - Dental Handpieces - Premarket Notification [510(k)] Submissions - 2007-05-02
Clinical Test Data:
Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on wellestablished scientific and engineering principles. Clinical testing has not been conducted on this product.
Conclusion:
Based on a comparison of intended use, indications, technological characteristics, principle of operation, features and performance data, the SMARTmatic is deemed to be substantially equivalent to the predicate device.