W&H HANDPIECE ANESTO, MODEL: RA-5

K083811 · W&H Dentalwerk Buermoos GmbH · EGM · Jan 14, 2010 · Dental

Device Facts

• Record ID: K083811
• Device Name: W&H HANDPIECE ANESTO, MODEL: RA-5
• Applicant: W&H Dentalwerk Buermoos GmbH
• Product Code: EGM · Dental
• Decision Date: Jan 14, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4475
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Drilling system to perforate cortical bone in order to administer local anesthesia in spongiosa; application in dentistry.

Device Story

RA-5 ANESTO is a dental handpiece designed for intraosseous anesthesia delivery. Device attaches to standard dental micro motors (air or electric) via ISO 3964 coupling; transmits rotational force to an attached needle to perforate cortical bone. Handpiece accommodates standard 1.7ml or 1.8ml anesthetic cartridges (ISO 11499). Following bone perforation, clinician uses a manual dosage lever to inject anesthetic directly into the spongiosa. Used by dentists in clinical settings to facilitate local anesthesia. Benefits include improved ease of operation and user-friendliness compared to previous integrated air-driven systems.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Handpiece with ISO 3964 coupling for dental micro motor attachment. Accommodates ISO 11499 anesthetic cartridges (1.7/1.8ml). Manual dosage lever for injection. Mechanical device; no software or electronic sensing.

Indications for Use

Indicated for dental patients requiring local anesthesia administration via perforation of cortical bone into the spongiosa.

Regulatory Classification

Identification

A spring-powered jet injector is a syringe device intended to administer a local anesthetic. The syringe is powered by a spring mechanism which provides the pressure to force the anesthetic out of the syringe.

Predicate Devices

• IntraFlow HTP (510(k) exempt)
• Cyberjet (K964802)

Submission Summary (Full Text)

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510(k) Handpiece RA-5 "ANESTO"

Section 5
Page 1 of 1

1083811

## 510(k) SUMMARY

| Applicant and Owner | W&H Dentalwerk Buermoos GmbH<br>Ignaz-Glaser-Strasse 53<br>A - 5111 Buermoos<br>Austria<br>Tel.: [phone]<br>Fax: [phone] |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Johann Georg SCHARL |
| Date of Preparation | December 19th, 2008 |
| Device Name | Handpiece RA-5 "ANESTO" |
| Classification Name | Spring Powered Jet Injector |
| Regulation Number | 21 CFR872.4475 |
| Product Code | EGM |
| Predicate Devices | "IntraFlow HTP", Pro-Dex Micro Motors Inc., 510(k) exempt<br>"Cyberjet", Intra Vantage Inc., K964802 |
| Device Description | RA-5 "ANESTO" is a handpiece, which, on the one hand, is<br>provided with a coupling system according to ISO 3964. This<br>coupling allows the handpiece's attachment onto a corresponding<br>dental motor, for transmitting the motor's rotational movement to<br>the attached intraosseous injection needle, intended to perforate<br>cortical bone.<br>On the other hand, it was designed for being equipped with an<br>anesthetic cartridge acc. ISO 11499, volume 1.7 or 1.8ml. After<br>having perforated the bone, this cartridge's anesthesia can be<br>administered locally in the spongiosa by means of a manually-<br>operated dosage lever.<br>"ANESTO's" application is intended in dentistry. |
| Intended Use: | Drilling system to perforate cortical bone in order to administer<br>local anesthesia in spongiosa; application in dentistry. |
| Technological<br>Characteristics | The Handpiece RA-5 "ANESTO", represents a revised and<br>improved version of the predicate device. The main technical<br>characteristics have been retained unchanged.<br>New: "ANESTO" is designed to be attached on and driven by a<br>dental micro motor (air or electric motor), instead by the integrated<br>air-supplied driving system of the predicate device. Furthermore,<br>the handpiece's shape and ease of operation have been<br>improved for more user-friendliness. |
| Comparison of the<br>device to the predicate<br>device | The intended use, technological characteristics, performance<br>parameter and material are very similar to the predicate device.<br>The new device is substantially equivalent to the predicate<br>devices. |
| Performance Testing | Bench testing results demonstrate substantially equivalence |
| Clinical Testing | Clinical data were not needed for this new product. |

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

JAN 1 4 2010

Mr. Johann G. Scharl Regulatory Affairs Manager W & H Dentalwerk Buermoos GmbH 53 Ignaz-Glaser-Strasse Buermoos Austria 5111

Re: K083811

Trade/Device Name: Handpiece RA-5 "ANESTO" Regulation Number: 21CFR 872.4475 Regulation Name: Spring-Powdered Jet Injector Regulatory Class: II Product Code: EGM Dated: January 7, 2010 Received: January 11, 2010

Dear Mr. Scharl:

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. Scharl

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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Wh for

Anthony D. Watson, BS, MS, MBA 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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## Indications for Use

510(k) number: K083811

Device Name: Handpiece RA-5 "ANESTO"

Indication for Use:

Drilling system to perforate cortical bone in order to administer local anesthesia in spongiosa. Application in dentistry.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over The Counter Use (Part 21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices

510(k) Number: KD83811

January 13th 2010

Rev. 01