The AIR-N-GO by SATELEC in supra-gingival configuration is intended for use in the polishing and cleaning of teeth by the projection of a mixture of dental powder, air, water on teeth surfaces. The device can remove soft deposits and areas of discolorali, watch can be used to prepare teeth for conventional dental procedures such as the placement of composite fillings, porcelain inlays, and laminate veneers... The device can be used to clean implant abutments and to clean teeth prior to treatments such as bhade matching, fluoridation, and bleaching. The device can be used to degrease crowns and bridges prior to placement and clean fixed bands and brackets on orthod ontic appliances.

The AIR-N-GO by SATELEC in sub-gingival configuration (with PERIO kit) is intended for patients suffering from periodontitis and peri-implantitis and it is indicated for the nonsurgical removal of sub-gingival plaque in pockets up to 5 mm after an initial period ontal treatment.

Device Description

The AIR-N-GO is a dental handpiece intended for the projection of a mixture of air, water and dental powder on the surface of teeth. It is supplied on air and water provided by a dental operative unit. The equipment is connected to a standard turbine connection available on the dental operative units.

The AIR-N-GO can be used with two different nozzles. A SUPRA nozzle is dedicated for the Supra-gingival dental applications whereas a PERIO nozzle is dedicated for the subgingival dental applications. The used nozzle is fixed on the front of the device by screwing. The AIR-N-GO can be used with two different heads. The head is available in two lengths according to ergonomics considerations. A front plastic body is the part of the medical device held in the hand of the user during the clinical act. Metallic tubing is used for the conduction of the mixture of air / dental powder and of the water.

A rear body is intended to receive the turbine connector. The rear body can rotate around the metallic tubing. This principle allows the orientation of the nozzle by rotation. The AIR-N-GO can be used with two different tanks. The mixture of the dental powder and the air is realized inside the tank. Tanks are equipped with a bayonet system for a quick change. A blue tank is dedicated for the supra-gingival dental applications. A green tank is dedicated for the sub-gingiyal dental applications. A tank lid is equipped with a powder stop system which permits to use the device as an air / water syringe. The AIR-N-GO is equipped with a turbine connector according to the model of dental operative unit used by the practitioner.

AI/ML Overview

The provided K110379 510(k) summary describes the SATELEC AIR-N-GO device, a dental handpiece for supra- and sub-gingival applications. The submission's focus is on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria through a clinical study. Therefore, the information requested regarding acceptance criteria, study design, and performance metrics in the context of an FDA-regulated AI/ML device is largely not present in this document.

Here's an attempt to extract the relevant information where possible, and highlight what is not applicable or not provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not define specific, quantifiable acceptance criteria in the typical sense of an AI/ML device (e.g., sensitivity, specificity, F1 score thresholds). Instead, it demonstrates substantial equivalence by comparing the technical specifications and performance of the AIR-N-GO to three predicate devices. The "acceptance criteria" are implied to be the performance and safety profiles of the predicate devices.

Feature / Performance Metric	Acceptance Criteria (Implied by Predicate Devices)	Reported Device Performance (AIR-N-GO)	Proof of Meeting Criteria (Comparison)
Supra-gingival Application Efficiency	Complete varnish removal, intact tooth surface, similar time efficiency to predicate devices.	Varnish completely eliminated, tooth surface remained intact. Time efficiency similar to predicate devices, except for a minor difference with tabletop unit's supra handpiece due to higher pressure.	Met: Direct comparative testing against predicate devices on dental study models showed similar effectiveness.
Sub-gingival Application Efficiency	Effective varnish removal on root surface and implant replica (up to 5mm depth), integrity of surface maintained.	Varnish removed effectively on root tooth and implant. Surface integrity maintained.	Met: Direct comparative testing against predicate devices on dental study models showed similar effectiveness.
Safety	No observed dangers or adverse effects compared to predicate devices.	No other danger was observed. Characteristics used with recommended dental powders do not affect safety.	Met: Evaluation tests stated no other dangers were observed and characteristics do not affect safety.
Technical Specifications (e.g., Weight, Operation Mode, Input Pressure, Operating/Storage Conditions)	Similar to predicate devices (as detailed in Table 2 of the original document).	Within comparable ranges or with minor, non-impactful differences.	Met: Table 2 explicitly compares and states "No difference" or "No impact" for most variables.
Technological Characteristics (e.g., Supply, Type, Technology, Materials, Nozzles, Tanks, Use Cases)	Similar to predicate devices (as detailed in Table 3 of the original document).	Similar technology, materials, and use cases, with some differences in convenience or reusability (e.g., reusable PERIO nozzle vs. single-use in predicates, which is seen as an economic advantage).	Met: Table 3 explicitly compares and states "No difference," "No impact," or explains advantageous differences.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size:
- Supra-gingival application: "Upper jaw central incisor of a dental study model." (Implies N=1 model, but testing was "repeatedly" on the "same tooth or implant.") The exact number of repetitions is not specified.
- Sub-gingival application: "Root of the upper jaw central incisor of a dental study model," and "an implant replica located on the lower jaw molar." (Implies N=2 distinct test sites on models). The varnish was applied "up to 5 mm."
Data Provenance: The testing was conducted on "dental study models," not human or animal subjects. The location (country of origin for the data) is not specified but is presumably France, where SATELEC (the submitter) is based. The data is prospective for this submission, as tests were conducted specifically to demonstrate equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention any experts used to establish ground truth. The "ground truth" (e.g., complete varnish removal, intact tooth surface) appears to be based on direct observation and comparison against established expectations for dental cleaning tools, rather than complex diagnostic interpretations requiring expert consensus.

4. Adjudication Method for the Test Set

No adjudication method is described, as the evaluation was based on objective observation of varnish removal and surface integrity on dental models.

5. 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

This is not applicable. The AIR-N-GO is a physical dental handpiece, not an AI/ML device, and no MRMC study, human reader performance, or AI assistance is mentioned or relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. The AIR-N-GO is a physical device operated by a human practitioner. It is not an algorithm.

7. The Type of Ground Truth Used

The ground truth used was observational:

Complete removal of varnish: This indicated the effectiveness of the cleaning.
Intact tooth/implant surface: This indicated the safety and non-damaging nature of the device's operation.
This is akin to "physical outcome" or "performance outcome" based on an experimental setup rather than clinical pathology or complex diagnostic outcomes.

8. The Sample Size for the Training Set

This is not applicable. The AIR-N-GO is a physical dental device, not an AI/ML algorithm. There is no concept of a "training set" for such a device.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as point 8.

Summary

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K11 0379

510(k) Pre-Market Notification for AIR-N-GO By SATELEC

EXHIBIT "A"

Page__________________________________________________________________________________________________________________________________________________________________________

SMDA Summary of Safety and Effectiveness - "510 (k) Summary"

A. Submitter Information SATELEC - ACTEON Group 17, Avenue Gustave Eiffel BP 30216 33708 Merignac Cedex FRANCE
011 33 556 34 0607 Telephone: Fax: 011 33 556 34 9292

Date prepared:

March 9, 2011

Contact Person:

Rick Rosati SATELEC c/o ACTEON, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 Tel: 800 289-6367 Ext. 39 Fax: 856 222-4726 Email: rick.rosati@us.acteongroup.com

B. Device Identification

Common Usual Name:

Dental Handpiece and Accessories

Proprietary Name:

Classification:

Class I device (per 21 CFR § 872.4200)

C. Identification of the Predicate Devices

	Predicate 1	Predicate 2	Predicate 3
Device name	EMS AIR-FLOW handyPERIO	EMS AIR-FLOW handy2	EMS AIR-FLOWMASTER
Sponsor	E.M.S ELECTROMEDICAL SYSTEMSSA	E.M.S ELECTROMEDICAL SYSTEMSSA	E.M.S ELECTROMEDICAL SYSTEMSSA
K number	K092289	K022119	K082791

AIR-N-GO

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510(k) Pre-Market Notification for AIR-N-GO Bv SATELEC

EXHIBIT "A"

Page

D. Device Description

E. Indications for Use

The AIR-N-GO by SATELEC in supra-gingival configuration is intended for use in the polishing and cleaning of teeth by the projection of a mixture of dental powder, air. water on teeth surfaces. The device can remove soft deposits and areas of discoloration and can be used to prepare teeth for conventional dental procedures such as the placement of composite fillings, porcelain inlays, and laminate veneers ... The device can be used to clean implant abutments and to clean teeth prior to treatments such as shade matching, fluoridation, and bleaching. The device can be used to degrease crowns and bridges prior to placement and clean fixed bands and brackets on orthodontic appliances.

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EXHIBIT "A"

F. Substantial Equivalence

The AIR-N-GO is the same as the EMS AIR-FLOW handy PERIO (K092289) predicate device in terms of principle. Both systems consist of a dental handpiece intended for the projection of a mixture of air, water and dental powder on the surface of teeth in sub-gingival dental applications, Also, both systems are composed of a tank, and lid tank and PERIO Nozzle. Both systems are connected to dental operative units with a turbine connector.

The AIR-N-GO is the same principle as the EMS AIR-FLOW handy 2 (K022119) predicate device in terms of principle. Both systems consist of a dental handpiece intended for the projection of a mixture of air, water and dental powder on the surface of teeth in supra-gingival dental application. Also, both systems are composed of a tank, and lid tank and 90° and 120° SUPRA Nozzle, Both systems are connected to dental operative units with a turbine connector.

The AIR-N-GO is the same principle as the EMS AIR-FLOW MASTER (K082791) predicate device in terms of principle. Both systems consist of a dental handpiece intended for the projection of a mixture of air, water and dental powder on the surface of teeth in supra-gingival dental application and sub-gingival dental applications. Both systems can be used for supra-gingival dental application and sub-gingival dental applications.

Evaluation tests have demonstrated the substantial equivalence of the AIR-N-GO device and these selected predicates for supra-gingival and sub-gingival applications. The effectiveness, the safety and the adverse effects have been evaluated during the tests. The results obtained are quite similar between each system. No other danger was observed.

The similarities in intended uses, operational characteristics, and functional technological characteristics between the AIR-N-GO. the EMS AIR-FLOW handy PERIO, the EMS AIR-FLOW handy 2 and the EMS AIR-FLOW MASTER lead to a conclusion of substantial equivalence between the proposed and predicate device. The AIR-N-GO device is substantially equivalent to the selected predicates.

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510(k) Pre-Market Notification for AIR-N-GO By SATELEC

14.b)

The AIR-N-GO technical specifications are similar to the predicate devices EMS AIR-FLOW handy PERIO, EMS AIR-FLOW handy 2 and EMS AIR-FLOW MASTER which already cleared for dental indications.

A direct comparison of the basic specification and performances of the AIR-N-GO with the predicate devices is summarized in Table 2.

	New Device	Predicate 1	Predicate 2	Predicate 3	Impact of thedifferences
Devicename	AIR-N-GO	EMS AIR-FLOW handyPERIO	EMS AIR-FLOW handy2	EMS AIR-FLOWMASTER
Weight	0.160 kg	0.160 kg	0.160 kg	5 Kg
Pictures	Image: AIR-N-GO	Image: EMS AIR-FLOW handy PERIO	Image: EMS AIR-FLOW handy 2	Image: EMS AIR-FLOW MASTER
Operationmode	Continuous	Continuous	Continuous	Continuous	No difference
Input Watersupplypressure	3 Bars max	0,7 à 1,5 bar	0,7 à 2,2 bar	1 à 5 Bars	No impact
Input Waterflow	10 to 20ml/min	20 to 80ml/min	50 to 80ml/min	Notcommunicated	10 to 20ml/min arecurrent valuefor use.
Input AirSupplypressure	3 to 4 Bars	3 to 4 Bars	3,5 to 4,5 Bars	5.5 à 7.5 Bars	No impact
Operatingconditions	+10°C to+40°C	+10°C to+40°C	+10°C to+40°C	+10°C to+40°C	No impact
Storage andtransportconditions	- 20°C to+ 70°C	-10 °C to+40 °C	-10°C to+40°C	-10°C to+40°C	No impact

TABLE 2- Technical Specifications and Performance Comparison

March 09, 2011

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14. c) __ Technology, Features, Materials and nozzle, Comparison

A direct comparison of the basic system technology, features, materials and nozzles of the AIR-N-GO with the predicate devices is summarized in Table 3.

New Device	Predicate 1	Predicate 2	Predicate 3	Impact of thedifferences
Device name	AIR-N-GO	EMS AIR-FLOW handyPERIO	EMS AIR-FLOW handy2	EMS AIR-FLOWMASTER
Supply	Air and Water	Air and Water	Air and Water	Air, Water, andElectric Power	There is noelectricalpower supply
Type	Handpiece	Handpiece	Handpiece	Handpiece	No difference
Technology	Connected ondentaloperative units	Connected ondentaloperative units	Connected ondentaloperative units	Connected tothe mains.Table top unit	Moreconvenient touse
HandpieceMaterial	Plastic andmetal	Plastic andmetal	Plastic andmetal	Plastic andmetal	No difference
Stop Powder	Yes	No	No	No	Allows rinsingthe clinical siteand the device
Head	Long headShort Head	Yes	Yes	PERIOhandpiece andSUPRAhandpiece	Moreconvenient touse
SUPRANozzle	Nozzle 90°Nozzle 120°(Reusable)	NO	Nozzle 90°Nozzle 120°(Reusable)	Nozzle fixedon thehandpiece(Reusable)	No difference
PERIONozzle	Yes(reusable)	Yes(single use)	No	Yes(single use)	Economicalaspect. Lessmoneyspending
CleaningProbe	Yes	Yes	Yes	Yes	No difference
Tank	PERIO Tankor SUPRAtank on therear of thedevice	On the middleof the device	On the middleof the device	PERIO Tankand SUPRAtank on thetable top unit	Better visibilityand usability
Supra-gingival use	Yes	No	Yes	Yes	No difference
Sub-gingivaluse	Yes	Yes	No	Yes	No difference

TABLE 3 - Technology, Features, Materials Comparison
------------------------------------------------------	--

15. Determination of Substantial Equivalence

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510(k) Pre-Market Notification for AIR-N-GO By SATELEC

Does New Device Have Same Indication Statements?

The AIR-N-GO indications for use are similar to the EMS AIR-FLOW handy PERIO for subgingival dental applications (PERIO). The AIR-N-GO indications for use are similar to the EMS AIR-FLOW handy 2 for supra-gingival dental applications (SUPRA). The AIR-N-GO indications for use are similar to the EMS AIR-FLOW MASTER for (PERIO) sub-gingival dental applications (PERIO) and supra-gingival dental applications (SUPRA).

Does New Device Have Same Technological Characteristics, e.g., Design, Materials, etc.?

The AIR-N-GO is the same as the EMS AIR-FLOW handy PERIO (K092289) predicate device in terms of principle. Both systems consist of a dental handbiece intended for the projection of a mixture of air, water and dental powder on the surface of teeth in subgingival dental applications. Also, both systems are composed of a fank, and lid tank and PERIO Nozzle. Both systems are connected to dental operative units with a turbine connector.

The AIR-N-GO is the same principle as the EMS AIR-FLOW handy 2 (K022119) predicate device in terms of principle. Both systems consist of a dental handpiece intended for the projection of a mixture of air, water and dental powder on the surface of teeth in supragingival dental application. Also, both systems are composed of a tank, and lid tank and 90° and 120° SUPRA Nozzle. Both systems are connected to dental operative units with a turbine connector.

The AIR-N-GO is the same principle as the EMS AIR-FLOW MASTER (K082791) predicate device in terms of principle. Both systems consist of a dental handpiece intended for the projection of a mixture of air, water and dental powder on the surface of teeth in supragingival dental application and sub-gingival dental applications. Both systems can be used for supra-gingival dental application and sub-gingival dental applications.

Is there a Summary of the non-clinical testing?

The evaluation was to demonstrate the substantial equivalence of the AIR-N-GO device and these selected predicates. In order to facilitate the evaluation, the devices were categorized in two groups according to their clinical applications: SUPRA for supra-gingival application and SUB for Sub-gingival application.

For the supra-gingival applications, the AIR-N-GO and the predicates have been tested on the upper jaw central incisor of a dental study model. A coat of varnish has been applied repeatedly on the same tooth or implant and each device has been used to remove it. The results obtained are quite similar between each system. The varnish was completely eliminated and the tooth surface treated remained intact. In terms of time efficiency the main difference remains on the use of the supra handpiece of the tabletop unit. It can be explained by the fact the device receives a pressure which is fairly high compared to the turbine connection systems. No other danger was observed.

Version 4

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510(k) Pre-Market Notification for AIR-N-GO By SATELEC

For the sub-gingival application the AIR-N-GO and the predicates have been be tested first on the root of the upper jaw central incisor of a dental study model . Then, the devices have been be tested on an implant replica located on the lower jaw molar. The varnish has been applied up to 5 mm. The devices have been used to remove varnish on root tooth or implant to verify the effectiveness and integrity of surface. The nozzle has been inserted up to 5mm in the pocket. The results obtained are quite similar between each system. There are no significant differences of the efficiency of removal of varnish between tooth and implant.

Could the New Characteristics Affect Safety or Effectiveness?

The AIR-N-GO is not a clinical innovation and the use is very well known by the practitioners. The AIR-N-GO is the same as the identified predicates in terms of clinical application. Also the used technologies and characteristics are similar to the predicates. The characteristics of the AIR-N-GO used with recommended dental powders do not affect the Safety of the patients or of the operator. Moreover, the A/R-N-GO device it is substantially equivalent to the declared predicate devices.

Conclusion

Based on the intended use and the technical characteristics of, the AIR-N-GO device it is substantially equivalent to the declared predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three arms reaching upwards, symbolizing health, support, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002

SATELEC C/O Mr. Rick Rosati Quality Manager ACTEON, Incorporated 124 Gaither Drive, Suite 140 Mount Laurel, New Jersey 08054

DEC - 8 2011

Re: K110379

Trade/Device Name: AIR-N-GO Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: September 15, 2011 Received: September 16, 2011

Dear Mr. Rosati:

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 - Mr. Rosati

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.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

h 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

510(k) Number: K110379

Device Name: AIR-N-GO

Indications for Use:

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

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 Rump

Division Sign-Uff) Division of Anesthesiology, General Hospital infection Control, Dental Devices

:10(k) Number: K110379

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.