SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST
Device Facts
| Record ID | K132356 |
|---|---|
| Device Name | SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST |
| Applicant | Scican GmbH |
| Product Code | EGS · Dental |
| Decision Date | Jan 31, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.4200 |
| Device Class | Class 1 |
| Attributes | Therapeutic, 3rd-Party Reviewed |
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.
Device Story
SANAO dental handpieces are reusable, ergonomically shaped instruments for general dentistry. Powered by air-motor or electronic micro-motor; models feature varying gear ratios (1:5, 1:1, 5:1) providing output rotations from 8,000 to 200,000 rpm. Some models include glass rod fiberoptic lighting and 1- or 3-port water/air spray systems. Operated by trained dental professionals in clinical settings. Input is motor power; output is rotary motion for dental burs/tools. Healthcare providers use the handpieces to remove decayed matter, prepare cavities/crowns, perform endodontics, and polish surfaces. Benefits include precise tooth structure removal and restoration finishing. Device connects to standard dental units via ISO 3964 couplings.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing and literature research. Bench testing verified compliance with ISO 7785-2 (Straight and Geared Angle Handpieces) and ISO 1797 (Shanks for rotary instruments).
Technological Characteristics
Materials: Stainless steel 304L (water lines), stainless steel with chrome and PEEK (patient contact surfaces). Energy: Air-motor or electronic micro-motor. Connectivity: ISO 3964 motor coupling, ISO 1797 instrument coupling. Form factor: Contra-angle and straight handpieces. Sterilization: Resterilizable. Standards: ISO 7785-2, ISO 1797, ISO 3964, ISO 10993-1, ISO 14971, ISO 17664, ISO 17665-1.
Indications for Use
Indicated for dental patients requiring cavity/crown preparation, caries excavation, endodontic procedures, removal of fillings, surface finishing of teeth/restorations, or prophylaxis treatment. For use by trained dental professionals.
Regulatory Classification
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.
Predicate Devices
- STATIS Models 1.5L / 1.1 / 1.1L / 4.1 / 1.1ST / 6.1 EFB (K071891)
Submission Summary (Full Text)
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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
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#### 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)
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### 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<br>(K071891) |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Picture | Image: SANAO 200L | Image: STATIS 1.5L |
| Indications for Use | This medical device is:<br>• intended for dental treatments only<br>• suggested for the following<br>applications:<br>The removal of decayed matter, cavity<br>and crown preparations, the removal of<br>fillings and surface finishing of tooth<br>and restoration surfaces. | This medical device is:<br>• intended for dental treatments only<br>• suggested for the following<br>applications:<br>Crown preparation and all other tasks<br>that require the highest level of<br>controlled power |
| | SANAO 200L | STATIS 1.5L<br>(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<br>micro-motor | Powered by air motor or electronic<br>micro-motor |
| Light | Yes | Yes |
| Fiberoptics | Yes | Yes |
| Dimensions (mm) | Head Height: 13.9<br>Head Ø: 10.2<br>Overall length:97.7 | Head Height: 15.2<br>Head Ø: 9.8<br>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<br>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 -<br>Air cooling | 8 Nl/mn at 2.5bar/36.3psi | 8-10 Nl/mn |
| Recommended settings -<br>air/water pressure | Spray air 2.7 bar/39.2 psi Water spray<br>2 bar/29 psi | Spray air 36 psi<br>Water spray 36 psi |
| | SANAO 200L | STATIS 1.5L<br>(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<br>Shaft Ø: 1.6mm<br>Length 25 mm | ISO 1797 type 3<br>Shaft Ø: 1.6mm<br>Length 21mm |
| | SANAO 40L / 40 | STATIS 1.1 / 1.1L<br>(K071891) |
| Picture | | |
| Indications for Use | This medical device is:<br>• intended for dental treatment only<br>• suggested for the following<br>applications: preparation of cavities,<br>caries excavation, endodontic<br>applications, processing of tooth and<br>restoration surfaces. | This medical device is:<br>• intended for dental treatment only<br>• suggested for the following<br>applications:<br>polishing, preparing, reducing and<br>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<br>micro-motor | Powered by air motor or electronic<br>micro-motor |
| Light | Yes, for L model | Yes, for L model |
| Fiberoptics | Yes | Yes |
| Dimensions (mm) | Head Height: 13.9<br>Head Ø: 10.2<br>Overall length:97.7 | Head Height: 15.2<br>Head Ø: 9.8<br>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<br>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<br>(K071891) |
| Light intensity | 11,300 LUX (for L model) | 6,300 Lux (for L model) |
| Bur Extraction force | > 45 N | >45N |
| Recommended settings -<br>air cooling | 8 NI/mn at 2.5bar/36.3psi | 8-10 NI/mn |
| Recommended settings -<br>air/water pressure | Spray air 2.7 bar/39.2 psi Water spray<br>2 bar/29 psi | Spray air 36 psi<br>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<br>Shaft Ø: 2.334 - 2.350mm<br>Length 22 mm | ISO 1797 type 1<br>Shaft Ø: 2.350mm<br>Length: Unknown |
| | SANAO 10L / 10 | STATIS 4.1<br>(K071891) |
| Picture | Image: SANAO 10L / 10 | Image: STATIS 4.1 |
| Indications for Use | This medical device is:<br>• intended for dental treatment only<br>• suggested for the following<br>applications:<br>preparation of cavities, caries<br>excavation, endodontic applications,<br>processing of tooth and restoration<br>surfaces. | This medical device is:<br>• intended for dental treatment only<br>• suggested for the following<br>applications:<br>4.1: removing caries, endodontics,<br>plaque and polishing of the tooth<br>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<br>micro-motor | Powered by air motor or electronic<br>micro-motor |
| Light | Yes, for L model | No |
| Fiberoptics | Yes, for L model | No |
| Dimensions (mm) | Head Height: 13.9<br>Head Ø: 10.2<br>Overall length:97.7 | Head Height: 15.2<br>Head Ø: 9.8<br>Overall length:95.8 |
| Type of chuck | Push button | Push button |
| Coupling with motor | ISO 3964 | ISO 3964 |
| | SANAO 10L / 10 | STATIS 4.1<br>(K071891) |
| Patient contact surfaces | Stainless Steel covered with Chrome<br>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 -<br>air cooling | 8 Nl/mn at 2.5bar/36.3psi | 8-10 Nl/mn |
| Recommended settings -<br>air/water pressure | Spray air 2.7 bar/39.2 psi Water spray 2<br>bar/29 psi | Spray air 36 psi<br>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<br>(K071891) |
| Picture | Image: SANAO 40 ST | Image: STATIS 1.1 ST |
| Indications for Use | This medical device is:<br>• only intended for dental treatment.<br>• suggested for the following<br>applications:<br>Removal of carious material, cavities<br>and crown preparations, removal of<br>fillings, processing of tooth and<br>restoration surfaces. | This medical device is:<br>• only intended for dental treatment.<br>• suggested for the following<br>applications:<br>Preparation in the anterior region,<br>osteotomy, root resection or extra-oral<br>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<br>micro-motor | Powered by air motor or electronic<br>micro-motor |
| Light | No | No |
| Fiberoptics | No | No |
| Dimensions (mm) | $Ø$ : 19.9<br>Overall length:83.7 | $Ø$ : 19.6<br>Overall length:84.9 |
| Type of chuck | Mechanical chuck | Mechanical chuck |
| | SANAO 40 ST | STATIS 1.1 ST<br>(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 -<br>air cooling | 8 NI/mn at 2.5bar/36.3psi | 8-10 Nl/mn |
| Recommended settings -<br>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<br>(K071891) |
| Picture | Image: SANAO PSI / PSO | Image: STATIS 6.1 |
| Indications for Use | This medical device is:<br>· only intended for dental treatment.<br>· suggested for the following<br>application: prophylaxis treatment | This medical device is:<br>· only intended for dental treatment.<br>· suggested for the following<br>applications:<br>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…
