DENTAL HANDPIECES, MODELS: KARAM STD/MINI; BREEZE STD/MINI: KARAM 45; DEXOR 45; KARAM 4H COUPLING

K101717 · Aerobine, Inc. · EFB · Aug 20, 2010 · Dental

Device Facts

• Record ID: K101717
• Device Name: DENTAL HANDPIECES, MODELS: KARAM STD/MINI; BREEZE STD/MINI: KARAM 45; DEXOR 45; KARAM 4H COUPLING
• Applicant: Aerobine, Inc.
• Product Code: EFB · Dental
• Decision Date: Aug 20, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

Karam STD, Karam Mini, Karam ECN, AeroBreeze STD, and AeroBreeze Mini models are airpowered highspeed dental handpieces with intended use of preparing dental cavities for restorations, such as fillings, reducing hard tooth structure, and cleaning teeth. Karam STD, Karam Mini, AeroBreeze STD, and AeroBreeze Mini can be used with either Type B (Karam 4B) or Type A (Karam 2A) coupling. Karam ECN model connects directly to either Type A or Type B hose connectors and does not require a coupling. Karam45 and Dexor45 are air-powered highspeed dental handpieces with intended use of being a surgical tool for impacted third molar removal and periodontal procedures for which a conventional handpiece would be used. Both models can be used with either Type B (Karam 4B) or Type A (Karam 2A) coupling.

Device Story

Air-powered dental handpieces; utilize cartridge-type air turbine; friction-grip push-button chuck; water delivery line for cooling/irrigation. Input: compressed air (29-36 psig). Output: high-speed bur rotation (380,000-450,000 RPM). Used in dental clinics by dentists/dental professionals. Models include straight-headed (Karam/AeroBreeze series) and 45-degree back angle (Karam45/Dexor45) for surgical access. Connects to dental unit via Type A/B couplings or direct hose connection. Facilitates cavity preparation, tooth reduction, and surgical procedures; improves clinical efficiency and patient outcomes through precise hard tissue removal.

Clinical Evidence

Bench testing only. Performance requirements (speed, torque, water flow, noise, bur extraction force, eccentricity) compared to predicates. Sterilization validation performed for autoclave cycles up to 135°C.

Technological Characteristics

Materials: stainless steel, aluminum alloy, copper alloy, chrome/nickel plating, elastomer. Energy: compressed air. Design: cartridge-type turbine, friction-grip push-button chuck, water cooling system. Standards: EN ISO 7785-1, ISO 9168, ISO 1797-1. Sterilization: autoclave (134-135°C). No electrical components.

Indications for Use

Indicated for dental cavity preparation, restoration (fillings), hard tooth structure reduction, and tooth cleaning. Also indicated for surgical removal of impacted third molars and periodontal procedures. For use by 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

• JINDELL Highspeed Air Turbine Handpiece (K062740)
• IMPACT Air 45 Handpiece for Periodontal Use (K972376)

Submission Summary (Full Text)

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Aerobine, Inc. 7670 Opportunity Rd. Suite 100
San Diego, CA 92111

4

مراهم م

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Tol) 858–277–1700
Fax) 858–571–7383

www.aerobine.com [e-mail]

163

# 5 510(k) SUMMARY

K101717

AUG 2 0 2010

## Aerobine Line of Dental Handpieces

| Submitted by: | Aerobine, Inc.<br>7670 Opportunity Rd. Suite 100<br>San Diego, CA 92111 |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Yong W. Kim, President<br>Tel: [phone]<br>Cell: 858-382-8526<br>Fax: [phone] email: [e-mail] |
| Date of Summary: | March 9, 2010 |
| Common name: | Air-powered Dental Handpiece |
| Device name: | Aerobine Line of Dental Handpieces: Karam STD, Karam Mini, Karam ECN,<br>AeroBreeze STD, AeroBreeze Mini, Karam45, Dexor45, Karam 4B coupling,<br>Karam 2A coupling |
| Classification: | Dental Handpiece and Accessories<br>Class I Medical Device: 21 CFR 872.4200<br>Product Code: EFB<br>Panel 72 |
| Predicate Devices: | JINDELL Highspeed Air Turbine Handpiece (K062740)<br>Product Code: EFB<br>IMPACT Air 45 Handpiece for Periodontal Use (K972376)<br>Product Code: EFB |

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Aerobine, Inc. 7670 Opportunity Rd. Suite 100 San Diego CA 92111

K101717

Tel) 858-277-1700
Fax) 858-571-7383

#### 5.1 Device Description

The devices are an air-powered dental handpieces intended for use with a friction-grip bur that conforms to ISO 1797-1 standard. Recommended air pressure is 29 ~ 36 psig (gage pressure) to produce high-speed bur rotation ranging between 380,000 and 450,000 RPM. Karam Mini, Karam ECN, AeroBreeze STD, and AeroBreeze Mini models are straight-headed. Karam45 and Dexor45 models are designed with a 45-degree back angle. The devices include a water line that directs water mist/jet to the cutting area for cooling and irrigation.

#### 5.2 Indications for use

Karam STD, Karam Mini, Karam ECN, AeroBreeze STD, and AeroBreeze Mini models are airpowered highspeed dental handpieces with intended use of preparing dental cavities for restorations, such as fillings, reducing hard tooth structure, and cleaning teeth. Karam STD, Karam Mini, AeroBreeze STD, and AeroBreeze Mini can be used with either Type B (Karam 4B) or Type A (Karam 2A) coupling. Karam ECN model connects directly to either Type A or Type B hose connectors and does not require a coupling.

Karam45 and Dexor45 are air-powered highspeed dental handpieces with intended use of being a surgical tool for impacted third molar removal and periodontal procedures for which a conventional handpiece would be used. Both models can be used with either Type B (Karam 4B) or Type A (Karam 2A) coupling.

#### 5.3 Description of device design

Aerobine line of handpieces employs a cartridge type air turbine with a common core design across the product line. All models employ a friction-grip push button chuck, a drive air line, a discharge air egress line, a water delivery line to supply cooling water. With the exception of Karam ECN, all models can be used with either Karam 4B or Karam 2A coupling. Karam ECN connects directly to Type A or Type B hose connectors without a coupling. Comparison of device technological characteristics relative to predicate devices is made in Table 1.

#### Conclusions from Technical Comparisons with predicate devices 5.4

Based on technological profile comparisons (Table 1) and engineering analysis results obtained in support of the sterilization validation effort (section 14), we conclude:

- Aerobine Handpieces, Karam STD/Mini/ECN, AeroBreeze STD/Mini are substantially equivalent to the predicate device (K062740) in terms of their intended use, operating principles, performance, material compositions, and sterilization characteristics.
- Aerobine Handpieces, Karam45, Dexor45 are substantially equivalent to the predicate device -(K972376) in terms of their intended use, operating principles, performance, material compositions, and sterilization characteristics.

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K101717

AEROBINE

3073

kerobine, Inc.
1670 Opportunity Rd. Suite 100
San Diego, CA 92111

ﺮ ﮐ

Tel) 858-277-1700 Fax) 858-571-7383

www.aerobine.com [e-mail]

- Aerobine Line of Dental Handpieces (Model: Karam STD, Karam Mini, Karam ECN, -AeroBreeze STD, AeroBreeze Mini, Karam45, Dexor45, Karam 4B coupling, Karam 2A coupling) are both safe and effective for their intended use.
### Table 1 Technological Characteristics Comparisons

| Technological<br>Characteristics | Karam<br>STD/Mini/ECN,<br>AeroBreeze STD/Mini | Comparison<br>to Predicate<br>Device<br>(K062740) | Karam45. Dexor45 | Comparison to<br>Predicate Device<br>(K972376) |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| Indication For<br>Use | For restoration and<br>cavity preparation | Identical | For surgical procedures<br>such as 3rd molar removal | Identical |
| Energy source | Compressed air | Identical | Compressed air | Identical |
| Design | Cartridge type turbine,<br>friction-grip push-button<br>chuck, cooling water<br>delivery system,<br>couplings | Identical | Cartridge type turbine,<br>friction-grip push-button<br>chuck, cooling water<br>delivery system,<br>couplings, rear air bleed<br>for improved infection<br>control | Identical Except:<br>non-catridge type<br>turbine |
| Minimum<br>Performance<br>requirements | Speed range, stall<br>torque, cooling water<br>flow rate, noise level,<br>bur extraction force,<br>eccentricity | Identical | Speed range, stall torque,<br>cooling water flow rate,<br>noise level, bur extraction<br>force, eccentricity | Identical |
| Standards met | EN ISO 7785-1<br>ISO 9168<br>ISO 1797-1 | Identical | EN ISO 7785-1<br>ISO 9168<br>ISO 1797-1 | Identical |
| Composition of<br>Materials | Stainless steel,<br>aluminum alloy, copper<br>alloy, chrome plating,<br>nickel plating, elastomer | Identical | Stainless steel, aluminum<br>alloy, copper alloy,<br>chrome plating, nickel<br>plating, elastomer | Identical |
| Biocompatibility | Constructed from usual<br>and common materials<br>known to the industry | Identical | Constructed from usual<br>and common materials<br>known to the industry | Identical |
| Sterility | Autoclave up to 135°C<br>15 minutes at 134 °C | Unknown | Autoclave up to 135°C<br>15 minutes at 134 °C | Autoclave up to<br>135°C<br>20 minutes at 135°C |
| Electrical Safety | No electrical connection | Identical | No electrical connection | Optional fiber-optic |
| Chemical Safety | Used corrosion-resistant<br>materials, free of<br>chemical hazard | Identical | Used corrosion-resistant<br>materials, free of<br>chemical hazard | Identical |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract, wave-like shapes stacked vertically.

Public Health Service

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

Aerobine, Incorporated C/O Ms. Paula Wilkerson Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

AUG 2 0 2010

Re: K101717

Trade/Device Name: Karam STD, Karam Mini, Karam ECN, AeroBreeze STD, AeroBreeze Mini, Karam45, Dexor45, Karam 4B coupling, and Karam 2A coupling Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: August 5, 2010 Received: August 6, 2010

Dear Ms. Wilkerson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

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### Page 2- Ms. Wilkerson

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Aerobine, Inc. 7670 Opportunity Rd. Suite 100 San Diego, CA 92111

K101717

AEROBINE

Tel) 858-277-1700
Fax) 858-571-7383

.aerobine.com
[e-mail]

#### Indications for Use 4

510(k) Number (if known):

Device Names: Karam STD, Karam Mini, Karam ECN, AeroBreeze STD, AeroBreeze Mini, Karam45, Dexor45. Karam 4B coupling, and Karam 2A coupling

### Indications For Use:

Karam STD, Karam Mini, Karam ECN, AeroBreeze STD, and AeroBreeze Mini models are airpowered highspeed dental handpieces with intended use of preparing dental cavities for restorations, such as fillings, reducing hard tooth structure, and cleaning teeth. Karam STD, Karam Mini, AeroBreeze STD, and AeroBreeze Mini can be used with either Type B (Karam 4B) or Type A (Karam 2A) coupling. Karam ECN model connects directly to either Type A or Type B hose connectors and does not require a coupling.

Karam45 and Dexor45 are air-powered highspeed dental handpieces with intended use of being a surgical tool for impacted third molar removal and periodontal procedures for which a conventional handpiece would be used. Both models can be used with either Type B (Karam 4B) or Type A (Karam 2A) coupling.

| Prescription Use | X AND/OR Over-The-Counter Use ______ |
|------------------|--------------------------------------|
|------------------|--------------------------------------|

(Part 21 CFR 801 Subpart D) (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)(Division Sign-Off) | Division of Anesthesiology, General Hospital<br>Infection Control, Dental Devices |
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