Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use focus on mechanical dental handpieces and their physical characteristics (speed, spray, lighting). There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.

Therapeutic

No
The device description and intended use indicate it is for mechanical dental procedures and prophylaxis, not for treating diseases or conditions with a therapeutic effect.

Diagnostic

No

The device is a dental handpiece intended for therapeutic and restorative dental procedures such as removal of decayed matter, cavity preparations, and surface finishing, rather than for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly describes physical dental handpieces with mechanical components (air-motor or electronic micro-motor, gear ratios, spray systems) and mentions bench testing related to physical properties and ISO standards. There is no indication of software being the primary or sole component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for "dental treatment in the area of dentistry" and lists applications like removing decayed matter, preparing cavities, and surface finishing. These are all procedures performed directly on the patient's teeth and mouth.
Device Description: The description details a dental handpiece used with motors and various tools for mechanical procedures.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.

IVD devices are specifically designed to perform tests on biological samples outside of the body. This device is a tool used within the body for mechanical dental procedures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

This medical device is only intended for dental treatment in the area of dentistry. Is is intended to be used for the following applications:

SANAO 200 L / 40 ST: The removal of decayed matter, cavity and crown preparations, the " removal of filings and surface finishing of tooth and restoration surfaces.
SANAO 40 / 40 L. / 10 / 10 L.: Cavity preparations, caries excavation, endodontics, surface . finishing of tooth and restoration surfaces.
SANAO PSI / PSO: prophylaxis treatment.

Product codes (comma separated list FDA assigned to the subject device)

EGS

Device Description

All SANAO Contra-Angle and Straight dental handpieces can be powered by an air-motor or an electronic micro-motor and are intended for use by trained professionals in the field of general dentistry. They are ergonomically shaped, reusable and some models are optionally available with a glass rod lighting system. Depending on the model the devices possess a 1- or 3- port spray or no spray. For different applications and tools there is a range of devices available with different transmissions for maximum output rotations ranging from 8,000 to 200,000 rpm. The devices are color-coded according to their respective gear ratio. The shanks of the instruments are in conformance with the respective ISO standards.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained professionals 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)

Bench testing was performed to evaluate that differences between SANAO and predicate devices do not affect safety and effectiveness. Bench testing demonstrated that the SANAO Handpieces met the requirement of the ISO 7785-2, with all samples compliant with ISO 7785-2 and demonstrating substantial equivalence to the predicates.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K071891

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

0

K132DS6

001_510k SUMMARY

Owner/Company name, address

SciCan GmbH Wangener Str. 78 88299 Leutkirch Germany

U.S. Contact

John Westermeier SciCan Inc. 701 Technology Drive Canonsburg, PA 15317 USA Phone: 949.887.6547

Application Correspondent Josef Sillet

Manager of Regulatory Affairs SciCan GmbH Wangener Str. 78 88299 Leutkirch Germany

Phone: +49-756198343-660 Fax: +49-756198343-699 E-Mail: jsillet@scican.com

Date prepared April 15th, 2013

Name of device
Trade Name: Classification Name: Regulation Name: Regulatory Class: Product Code:

SANAO Handpiece, Contra- And Right-Angle Attachment, Dental Dental handpiece and accessories Class I EGS

JAN 31 2014

1

Predicate devices

The SANAO is substantially equivalent to the following legally marketed devices:

K071891 510(k): Trade name: STATIS Models 1.5L / 1.1 / 1.1L / 4.1 / 1.1ST / 6.1 EFB Product code: Classification Name: Handpiece, Air-powered, Dental

The STATIS Handpieces Slow-Speed Models STATIS 1.5L / 1.1 / 1.1L / 4.1 / 1.1ST / 6.1 are the exact predicate devices for SANAO Handpieces 200L / 40L / 40 / 40ST/ 10L / 10 / PSI / PSO.

Description of the device

All SANAO Contra-Angle and Straight dental handpieces can be powered by an air-motor or an electronic micro-motor and are intended for use by trained professionals in the field of general dentistry. They are ergonomically shaped, reusable and some models are optionally available with a glass rod lighting system. Depending on the model the devices possess a 1- or 3- port spray or no spray. For different applications and tools there is a range of devices available with different transmissions for maximum output rotations ranging from 8,000 to 200,000 rpm. The devices are color-coded according to their respective gear ratio. The shanks of the instruments are in conformance with the respective ISO standards.

、Statement of intended use

The SANAO instruments are intended to be used for general dentistry work. The intended use of the respective instruments is depending on the gear ratio.

SANAO 200 L / 40 ST: The removal of decayed matter, cavity and crown preparations, the removal of fillings and surface finishing of tooth and restoration surfaces.
SANAO 40 / 40 L / 10 / 10 L: Cavity preparations, caries excavation, endodontics, surface finishing of tooth and restoration surfaces.
SANAO PSI / PSO: prophylaxis treatment. -

Summary of Technological Characteristics

The devices have been designed according to the following standards:

Performance	ISO - 7785-2 Straight and Geared Angle Handpieces
Coupling for instruments	ISO - 1797 Dentistry – Shanks for rotary instruments
Coupling for motor	ISO - 3964 Dental Handpieces Coupling dimensions

For user comfort, the SANAO handpieces are ergonomically shaped. All contact surfaces with the patient are made out of stainless steel. The devices can be powered by an air-motor or an electronic micro-motor. Some models are available with a glass rod lighting system. Depending on the model the devices either possess a 1- or a 3- port spray or no spray. The different transmissions allow for different maximum output rotations ranging from 8,000 to 200,000 rpm.

SciCan SANAO 510(k)

2

Image /page/2/Picture/0 description: The image shows the word "SciCan" in a stylized font. The letters are in a dark gray color, and the "i" has a dot above it that is slightly offset to the right. The font appears to be a serif font, and the letters are slightly rounded.

Clinical and non-clinical tests

A non-clinical evaluation, based on literature research, has been done. The evaluation of the applicable market data showed that SANAO handpieces do not pose more known or new clinical risks than similar medical devices currently on the market. Based on those results clinical test have not been executed.

Statement of substantial equivalence

The SANAO dental handpieces are similar in design, function and intended use to other dental handpieces currently distributed in the U.S. An example for substantially equivalent devices are the STATIS Contra-Angle and Straight Handpieces.

The following tables show a comparison between the different SANAO dental handpieces and the predicates.

Comparison SANAO 200L / STATIS 1.5L

| | SANAO 200L | STATIS 1.5L
(K071891) |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Picture | Image: SANAO 200L | Image: STATIS 1.5L |
| Indications for Use | This medical device is:
• intended for dental treatments only
• suggested for the following
applications:
The removal of decayed matter, cavity
and crown preparations, the removal of
fillings and surface finishing of tooth
and restoration surfaces. | This medical device is:
• intended for dental treatments only
• suggested for the following
applications:
Crown preparation and all other tasks
that require the highest level of
controlled power |
| | SANAO 200L | STATIS 1.5L
(K071891) |
| | | |
| Design | Contra-Angle | Contra-Angle |
| Ratio | 1:5 | 1:5 |
| identification | Red | Red |
| Cooling | Water/Air | Water/Air |
| Spray | Yes | Yes |
| Air water ports | 3 port | 3 port |
| Operational modes | Powered by air motor or electronic
micro-motor | Powered by air motor or electronic
micro-motor |
| Light | Yes | Yes |
| Fiberoptics | Yes | Yes |
| Dimensions (mm) | Head Height: 13.9
Head Ø: 10.2
Overall length:97.7 | Head Height: 15.2
Head Ø: 9.8
Overall length:95.8 |
| Type of chuck | Push button | Push button |
| Coupling with motor | ISO 3964 | ISO 3964 |
| Coupling instrument | ISO 1797 type 3 (1,60mm) | ISO 1797 type 3 (1,60mm) |
| Composition of materials | | |
| Patient contact surfaces | Stainless Steel covered with Chrome
PEEK | Stainless Steel covered with Chrome |
| Water Lines | Stainless steel 304L | Stainless steel 304L |
| Technical specification | | |
| Chuck | Push button | Push button |
| Light intensity | 7,500 LUX | 5,000 Lux |
| Bur Extraction force | > 22N | >22N |
| Recommended settings -
Air cooling | 8 Nl/mn at 2.5bar/36.3psi | 8-10 Nl/mn |
| Recommended settings -
air/water pressure | Spray air 2.7 bar/39.2 psi Water spray
2 bar/29 psi | Spray air 36 psi
Water spray 36 psi |
| | SANAO 200L | STATIS 1.5L
(K071891) |
| Speed input max. | 40,000 rpm | 40,000 rpm |
| Speed output max. | 200,000 rpm | 200,000 rpm |
| Chuck design | ISO 1797 type 3
Shaft Ø: 1.6mm
Length 25 mm | ISO 1797 type 3
Shaft Ø: 1.6mm
Length 21mm |
| | SANAO 40L / 40 | STATIS 1.1 / 1.1L
(K071891) |
| Picture | | |
| Indications for Use | This medical device is:
• intended for dental treatment only
• suggested for the following
applications: preparation of cavities,
caries excavation, endodontic
applications, processing of tooth and
restoration surfaces. | This medical device is:
• intended for dental treatment only
• suggested for the following
applications:
polishing, preparing, reducing and
excavation |
| Device Design | | |
| Design | Contra-Angle | Contra-Angle |
| Ratio | 40L / 40 1:1 | 1.1/ 1.1L 1:1 |
| identification | Blue | Blue |
| Cooling | Water/Air | Water/Air |
| Spray | Yes | Yes |
| Air water ports | 1 port | 3 port |
| Operational modes | Powered by air motor or electronic
micro-motor | Powered by air motor or electronic
micro-motor |
| Light | Yes, for L model | Yes, for L model |
| Fiberoptics | Yes | Yes |
| Dimensions (mm) | Head Height: 13.9
Head Ø: 10.2
Overall length:97.7 | Head Height: 15.2
Head Ø: 9.8
Overall length:95.8 |
| Type of chuck | Push button | Push button |
| Coupling with motor | ISO 3964 | ISO 3964 |
| Coupling instrument | ISO 1797 type 1 (2,35mm) | ISO 1797 type 1 (2,35mm) |
| Composition of materials | | |
| Patient contact surfaces | Stainless Steel covered with Chrome
PEEK | Stainless Steel covered with Chrome |
| Water Lines | Stainless steel 304L | Stainless steel 304L |
| Technical specification | | |
| Chuck | Push button | Push button |
| | SANAO 40L / 40 | STATIS 1.1 / 1.1L
(K071891) |
| Light intensity | 11,300 LUX (for L model) | 6,300 Lux (for L model) |
| Bur Extraction force | > 45 N | >45N |
| Recommended settings -
air cooling | 8 NI/mn at 2.5bar/36.3psi | 8-10 NI/mn |
| Recommended settings -
air/water pressure | Spray air 2.7 bar/39.2 psi Water spray
2 bar/29 psi | Spray air 36 psi
Water spray 36 psi |
| Speed input max. | 40,000 rpm | 40,000 rpm |
| Speed output max. | 40,000 rpm | 40,000 rpm |
| Chuck design | ISO 1797 type 1
Shaft Ø: 2.334 - 2.350mm
Length 22 mm | ISO 1797 type 1
Shaft Ø: 2.350mm
Length: Unknown |
| | SANAO 10L / 10 | STATIS 4.1
(K071891) |
| Picture | Image: SANAO 10L / 10 | Image: STATIS 4.1 |
| Indications for Use | This medical device is:
• intended for dental treatment only
• suggested for the following
applications:
preparation of cavities, caries
excavation, endodontic applications,
processing of tooth and restoration
surfaces. | This medical device is:
• intended for dental treatment only
• suggested for the following
applications:
4.1: removing caries, endodontics,
plaque and polishing of the tooth
surface after oral hygiene treatment |
| Device Design | | |
| Design | Contra-Angle | Contra-Angle |
| Ratio | 5:1 | 4:1 |
| identification | Green | Green |
| Cooling | Water/Air | Water/Air |
| Spray | Yes | Yes |
| Air water ports | 1 port | 3 port |
| Operational modes | Powered by air motor or electronic
micro-motor | Powered by air motor or electronic
micro-motor |
| Light | Yes, for L model | No |
| Fiberoptics | Yes, for L model | No |
| Dimensions (mm) | Head Height: 13.9
Head Ø: 10.2
Overall length:97.7 | Head Height: 15.2
Head Ø: 9.8
Overall length:95.8 |
| Type of chuck | Push button | Push button |
| Coupling with motor | ISO 3964 | ISO 3964 |
| | SANAO 10L / 10 | STATIS 4.1
(K071891) |
| Patient contact surfaces | Stainless Steel covered with Chrome
PEEK | Stainless Steel covered with Chrome |
| Water Lines | Stainless steel 304L | Stainless steel 304L |
| Technical specification | | |
| Chuck | Push button | Push button |
| Light intensity | 10,300 LUX (for L model) | Not applicable |
| Bur Extraction force | > 45N | > 45N |
| Recommended settings -
air cooling | 8 Nl/mn at 2.5bar/36.3psi | 8-10 Nl/mn |
| Recommended settings -
air/water pressure | Spray air 2.7 bar/39.2 psi Water spray 2
bar/29 psi | Spray air 36 psi
Water spray 36 psi |
| Speed input max. | 40,000 rpm | 40,000 rpm |
| Speed output max. | 8,000 rpm | 10,000 rpm |
| | ISO 1797 type 1 | ISO 1797 type 1 |
| Chuck design | Shaft Ø: 2.334 - 2.350 mm | Shaft Ø: 2.350 mm |
| | Length 25 mm | Length: unknown |
| | | |
| | SANAO 40 ST | STATIS 1.1 ST
(K071891) |
| Picture | Image: SANAO 40 ST | Image: STATIS 1.1 ST |
| Indications for Use | This medical device is:
• only intended for dental treatment.
• suggested for the following
applications:
Removal of carious material, cavities
and crown preparations, removal of
fillings, processing of tooth and
restoration surfaces. | This medical device is:
• only intended for dental treatment.
• suggested for the following
applications:
Preparation in the anterior region,
osteotomy, root resection or extra-oral
prosthesis correction. |
| Device Design | | |
| Design | Straight handpiece | Straight handpiece |
| Ratio | 1:1 | 1:1 |
| identification | Blue | Blue |
| Cooling | Water/Air | Water/Air |
| Spray | Yes | Yes |
| Air water ports | 1 port | 1 port |
| Operational modes | Powered by air motor or electronic
micro-motor | Powered by air motor or electronic
micro-motor |
| Light | No | No |
| Fiberoptics | No | No |
| Dimensions (mm) | $Ø$ : 19.9
Overall length:83.7 | $Ø$ : 19.6
Overall length:84.9 |
| Type of chuck | Mechanical chuck | Mechanical chuck |
| | SANAO 40 ST | STATIS 1.1 ST
(K071891) |
| Coupling with motor | ISO 3964 | ISO 3964 |
| Coupling instrument | ISO 1797 type 2 (2,35mm) | ISO 1797 type 2 (2,35mm) |
| Composition of materials | | |
| Patient contact surfaces | Stainless Steel covered with Chrome | Stainless Steel covered with Chrome |
| Water Lines | Stainless steel 304L | Stainless steel 304L |
| Technical specification | | |
| Chuck | Mechanical chuck | Mechanical chuck |
| Light intensity | Not applicable | Not applicable |
| Bur Extraction force | > 45N | >45N |
| Recommended settings -
air cooling | 8 NI/mn at 2.5bar/36.3psi | 8-10 Nl/mn |
| Recommended settings -
air/water pressure | Spray air 2.7 bar/39.2 psi Water spray | Spray air 36 psi |
| air/water pressure | 2 bar/29 psi | Water spray 36 psi |
| Speed input max. | 40,000 rpm | 40,000 rpm |
| Speed output max. | 40,000 rpm | 40,000 rpm |
| | ISO 1797 type 2 | ISO 1797 type 2 |
| Chuck design | Shaft Ø: 2.334 - 2.350 mm | Shaft Ø: 2.350 |
| | Length 25 mm | Length: unknown |
| | | |
| | SANAO PSI / PSO | STATIS 6.1
(K071891) |
| Picture | Image: SANAO PSI / PSO | Image: STATIS 6.1 |
| Indications for Use | This medical device is:
· only intended for dental treatment.
· suggested for the following
application: prophylaxis treatment | This medical device is:
· only intended for dental treatment.
· suggested for the following
applications:
prophylaxis |
| Device Design | | |
| Design | Contra-Angle | Contra-Angle |
| Ratio | 5:1 | 6:1 |
| identification | Green | Green |
| Cooling | Not applicable | Not applicable |
| Spray | No | No |
| Air water ports | None | None |
| Operational modes | Powered by air motor or electronic
micro-motor | Powered by air motor or electronic
micro-motor |
| Light | No light | No light |
| Fiberoptics | None | None |
| Dimensions (mm) | Head Height: PSI 10.8mm PSO
13.8mm
Head Ø: 8.2
Overall length:96.7 | Head Height: 15.2
Head Ø: 7.3
Overall length:88.7 |
| Type of chuck | Not applicable | Not applicable |
| Coupling with motor | ISO 3964 | ISO 3964 |
| Coupling instrument | PSI with Screw-In-Function (with ISO
13295 type 3) | For mandrels with Snap-On-Function
(ISO 13295 type 5) or mandrels with
Screw-In function (ISO 13295 type 3) |
| | SANAO PSI / PSO | STATIS 6.1
(K071891) |
| | Function (ISO 13295 type 5) | |
| Composition of materials | | |
| Patient contact surfaces | Stainless Steel covered with Chrome
PEEK | Stainless Steel covered with Chrome |
| Water Lines | No water line | No water line |
| Technical specification | | |
| Chuck | No chuck | No chuck |
| Light intensity | Not applicable | Not applicable |
| Bur Extraction force | Not applicable | Not applicable |
| Recommended settings -
air cooling | Not applicable | Not applicable |
| Recommended settings -
air/water pressure | Not applicable | Not applicable |
| Speed input max. | 40,000 rpm | 40,000 rpm |
| Speed output max. | 8,000 rpm | 6,666 rpm |
| Chuck design | No chuck | No chuck |

3

SciCan

: ·

. . . . .

SciCan SANAO 510(k)

4

the state the state of the states of the states

.

. . . . .

.

SciCan SANAO 510(k) ،

:

5

Comparison SANAO 40L / 40 STATIS vs. 1.1 / 1.1L

6

7

Comparison SANAO 10L / 10 vs. STATIS 4.1

8

Image /page/8/Picture/0 description: The image shows the word "SciCan" in a bold, sans-serif font. The letters are closely spaced together, giving the word a compact appearance. The overall impression is clean and professional.

9

Comparison SANAO 40 STvs. STATIS 1.1 ST

10

SciCan

・

.

:

.

11

Comparison SANAO PSI / PSO vs. STATIS 6.1

12

As shown in the comparison tables, the indications for use of the SANAO dental handpieces are substantially equivalent to those of the SciCan STATIS Handpieces (K071891). As described above, the principle of operation and design features of the SANAO Handpieces are identical to those of the predicates. The gear ratio of SANAO PSI / PSO / 10 / 10L is different to that of the predicates. Therefore, the maximum rotation speed at the chuck is different between the SANAO PSI / PSO / 10 / 10L and the predicates. Also some differences can be found in the light intensity, dimensions and the external material from SANAO to STATIS. In order to evaluate that those differences do not affect safety and effectiveness of the SANAO Handpieces bench testing was performed. Bench testing demonstrated that the SANAO Handpieces met the requirement of the ISO 7785-2 which was used for evaluation of the predicate devices. Based on the above results, the SANAO Handpieces are substantially equivalent to the predicates and do not raise any new safety and effectiveness concern.

Bench Testing

The Bench tests were performed in order to ensure the safety and effectiveness of the SANAO Handpieces, verify conformity to ISO 7785-2 and demonstrate substantial equivalence to the predicates. All samples were compliant with ISO 7785-2 and demonstrated substantial equivalance to the predicates.

13

Image /page/13/Picture/0 description: The image shows the word "SciCan" in a bold, sans-serif font. The letters are closely spaced, and the overall appearance is clean and modern. The image is simple and straightforward, with the focus entirely on the text.

Risk analysis method & actions

A Risk Management Plan to identify the risks and activities for managing those risks was carried out during design and development of the SANAO Dental handpieces, accessories and associated devices.

The Risk Analysis of the SANAO line of dental handpieces was conducted in accordance with ISO 14971: 2007. The analysis showed that the level of risk associated with the SANAO handpieces is minor and not any greater as the level of risks identified for similar medical devices currently on the market.

Applicable Standards

| Standards
No. | Standards
Organization | Standards Title | Version | |
|------------------|---------------------------|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| 1 | ISO 10993-1 | ISO | Biological evaluation of medical devices | 2009 |
| 2 | ISO 14971 | ISO | Medical devices - Application of risk
management to medical devices | 2007 |
| 3 | ISO 7785-2 | ISO | Dental Handpieces - Part 2
Straight and Geared Angled Handpieces | 1995 |
| 4 | ISO 17664 | ISO | Sterilization of medical devices - Information
to be provided by the manufacturer for the
processing of resterilizable medical devices | 2004 |
| 5 | ISO 17665-1 | ISO | Sterilization of health care products - Moist
heat - Part 1: Requirements for the
development, validation and routine control
of a sterilization process for medical devices | 2006 |
| 6 | ISO 9687 | ISO | Dental equipment - Graphical symbols | 1995 |
| 7 | ISO 21531 | ISO | Dentistry - Graphical symbols for dental
instruments | 2009 |
| 8 | ISO 3964 | ISO | Dental Handpieces - Coupling Dimensions | 1982 |
| 9 | ISO 1797-1 | ISO | Dental Rotary Instruments - Shanks | 2011 |

Conclusion

The indications for Use of the SANAO Handpieces are substantially equivalent to those of the SciCan STATIS (K071891). In addition, the principle of operation and design features of the SANAO Handpieces are identical to those of the predicates. The gear ratio of the SANAO PSI / PSO / 10 / 10L is different to that of the predicates. Therefore, the maximum rotation speed at the chuck is different between the SANAO PSI / PSO / 10 / 10L and the predicates. There are also some

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differences in the light intensions and the external material from SANAO to the predicates. Although there are those differences in characteristics between the SANAO Handpieces and the predicates, a number of performance testing indicated that the SANAO Handpieces met the requirements of the recognized consensus or voluntary standard. Based on the above results, we conclude that the SANAO-Handpieces are substantially equivalent to the predicates and do not raise any new safety and effectiveness concem.

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Image /page/15/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 31,2014

SciCan GmbH C/O Mr. Alexander Schapovalov TUV SUD American, Incorporated 1775 Old Highway 8 NW, Suite 104 New Brighton, MN 56112-1891

Re: K132356

Trade/Device Name: SANAO Dental Handpieces Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EGS Dated: January 12, 2014 Received: January 16, 2014

Dear Mr. Schapovalov:

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.

16

Page 2 – Mr. Schapovalov

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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for

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

17

001_INDICATION FOR USE STATEMENT

510(k) Number (if known): K 132356

Device Name:

SANAO Dental Handpieces

Indications for Use

This medical device is only intended for dental treatment in the area of dentistry. Is is intended to be used for the following applications:

SANAO 200 L / 40 ST: The removal of decayed matter, cavity and crown preparations, the " removal of filings and surface finishing of tooth and restoration surfaces.
SANAO 40 / 40 L. / 10 / 10 L.: Cavity preparations, caries excavation, endodontics, surface . finishing of tooth and restoration surfaces.
SANAO PSI / PSO: prophylaxis treatment. t

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner DDS, AA Mary S. Runner -S
2014.01.31
08:22:05 -05'00'