IMPLANTEO IMPLANTOLOGY MOTOR

K041279 · Anthogyr · EKX · Sep 23, 2004 · Dental

Device Facts

• Record ID: K041279
• Device Name: IMPLANTEO IMPLANTOLOGY MOTOR
• Applicant: Anthogyr
• Product Code: EKX · Dental
• Decision Date: Sep 23, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

IMPLANTEO dental unit is indicated to perform dental implant surgery, such as perforating the bone and taping and threading procedures required before placement of implant prosthetics,

Device Story

IMPLANTEO is a dental surgical motor system for implantology; used by clinicians in dental settings. System components include control unit, peristaltic pump, motor, motor holder, control pedal, and calibration module. Device inputs include user-defined parameters: speed, torque, pump flow rate, and contra-angle reduction ratio. System supports up to 3 programmable protocols, each covering 4 surgical sequences: drilling, reaming, tapping, and screwing. Output is mechanical rotation of surgical handpiece for bone preparation. Clinician monitors parameters via large screen; adjusts settings to control surgical procedure. System facilitates precise bone preparation for implant placement, potentially improving surgical outcomes.

Clinical Evidence

Bench testing only. Device conforms to IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), ISO 11498 (dental motors), ISO 13402 (autoclaving/corrosion), and NF EN ISO 7494 (dental units). No clinical data provided.

Technological Characteristics

Dental surgical motor system. Components: control unit, peristaltic pump, motor, pedal. Materials: stainless steel (per NF EN ISO 7153-1). Parameters: adjustable speed, torque, pump flow, reduction ratio. Connectivity: standalone unit. Sterilization: compatible with autoclaving (ISO 13402). Power: electrical motor.

Indications for Use

Indicated for patients undergoing dental implant surgery requiring bone perforation, tapping, and threading procedures prior to prosthetic placement.

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

• ATR 5000 Implant system (K033597)
• VCT Versatile Control Technology Model AEU-925 (K030163)

Submission Summary (Full Text)

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## SEP 2 3 2004

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

#### 1. GENERAL INFORMATION

| Submitter | ANTHOGYR (Registration number 8020776) |
|---------------------|-----------------------------------------------------------|
| | 164 rue des trois lacs |
| | 74700 SALLANCHES FRANCE |
| | Phone: [phone] Fax: [phone] |
| Contacts | Eric GENEVE (RD Manager) [e-mail] |
| | Regulatory Affairs: Idée Consulting (Dr Isabelle DRUBAIX) |
| | [e-mail] |
| Common Name | Surgical motor for implantology |
| Classification Name | Dental Handpieces and accessories |
| Trade Name | IMPLANTEO |
| Class | I |
| Product Code | EKX |
| CFR section | 872.4200 |
| Device panel | DENTAL |

### 2. DEVICE DESCRIPTION

ANTHOGYR has developed a dental unit intended to perform dental implant surgery which is substantially equivalent to legally marketed and FDA cleared predicate devices.

IMPLANTEO kit includes: Control unit, Peristaltic pump, Motor, Motor, Motor holder, Control pedal, Calibration module, Bag carner

Four adjustable parameters are displayed on a large size screen : Speed which adjustment takes into account the reduction value used, Torque, Pump flow rate and Contra angle reduction ratio

In order to cover all the possible uses of the motor, up to 3 different protocols can be programmed. Each protocol allows for implant fitting in 4 sequences: drilling, reaming, tapping and screwing.

#### 3. INTENDED USE

IMPLANTEO dental unit is indicated to perform dental implant surgery, such as perforating the bone and taping and threading procedures required before placement of implant prosthetics,

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#### 4. PERFORMANCE DATA

IMPLANTEO conforms to the following voluntary FDA recognized Consensus standards:

- IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for . Safety
- IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements for . Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- ISO 11498 (1997) Dental Handpieces: Dental Low Voltage Electrical Motors .
- ISO 13402 (1995) « Surgical and dental hand instruments Determination of . resistance against autoclaving, corrosion and thermal exposure »
- ISO 15223 (2000) « Medical devices Symbols to be used with medical device . labels, labeling and information to be supplied »
- NF EN ISO 7494 (1997) Dental units .
- NF EN ISO 7153-1 (2000) Surgical instruments Metallic materials Part 1 : . stainless steel
- EN 1441 (1997) "Medical devices Risk management" .

#### 5 SUBSTANTIAL EQUIVALENCE

Predicate devices:

K033597 - ATR 5000 Implant system - Advanced Technology Research K030163 -VCT Versatile Control Technology Model AEU -925 - Aseptico

IMPLANTEO is substantially equivalent to these predicate devices in terms of intended use, material, design and function.

Summary preparation date: April 30, 2004

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SEP 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Eric Geneve R & D Manager ANTHOGYR 164 Rue Des Trois Lacs 74700 Sallanches FRANCE

Re: K041279

Trade/Device Name: IMPLANTEO Implantology Motor Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: August 3, 2004 Received: August 3, 2004

Dear Mr. Geneve:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Geneve

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Kummer
O. Shi-Lin, Ph.D.

Chiu Lin, Ph.D. 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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510(k) Premarket Notification IMPLANTEO Implantology Motor

Image /page/4/Picture/1 description: The image shows the word "anthogyr" in a stylized font above three small, square images. The first image on the left appears to be a textured or patterned design. The middle image contains a series of parallel lines or bars, possibly representing a ladder or a similar structure. The image on the right is dark and contains a circular shape with internal details, possibly representing a gear or a mechanical component.

510(k) Number (if known):

Device Name: IMPLANTEO Implantology Motor

Indications for Use: IMPLANTEO motor is indicated to perform dental implant surgery, such as perforating the bone and taping and threading procedures required before placement of implant prosthetics.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

or

Over-the-Counter Use

(Optional Format 1-2-96)

(PER 21 CFR 801.109)

Susan Punne

(Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number ._

Number: Kolia75

2-003