ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT

K102241 · Anthogyr Sas · EBW · Mar 23, 2011 · Dental

Device Facts

• Record ID: K102241
• Device Name: ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT
• Applicant: Anthogyr Sas
• Product Code: EBW · Dental
• Decision Date: Mar 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

IMPLANTEO implantology and dental surgery motor unit are indicated to perform dental implant surgery, such as perforating the bone and tapping and threading procedures required before placement of implant prosthetics.

Device Story

Motor unit for dental implant surgery; performs bone perforation, tapping, and threading. Device consists of motor unit and contra-angle handpiece. Operated by dental professionals in clinical settings. Provides mechanical power to surgical instruments; facilitates preparation of bone site for implant placement. Benefits patient by enabling precise surgical site preparation for prosthetic restoration. Device represents design improvements to non-essential characteristics of predicate systems; maintains fundamental scientific technology and operating principles.

Clinical Evidence

Bench testing only. Device conforms to recognized consensus standards including ISO 15223-1, IEC 60601-1, IEC 60601-1-2, ISO 7785-2, ISO 3964, ISO 14971, ISO 13485, NF EN ISO 1797-1, and NF EN ISO 17664.

Technological Characteristics

Dental motor unit and contra-angle handpiece. Materials conform to ISO 1797-1. Standards: ISO 15223-1, IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), ISO 7785-2, ISO 3964 (coupling dimensions), ISO 14971 (risk management), ISO 13485 (quality management). Sterilization per NF EN ISO 17664. Low-voltage electrical motor.

Indications for Use

Indicated for patients requiring dental implant surgery, specifically for bone perforation, tapping, and threading procedures prior to implant 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

• ANTHOGYR Implanteo (K041279)
• ANTHOGYR contra-angle (K090676)
• BIEN-AIR CHIROPRO L (K092214)
• W&H implantMED (K052741)

Reference Devices

• NSK contra-angle (K970953)
• W&H contra-angle (K080939)

Submission Summary (Full Text)

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510(k) – « IMPLANTEO » Implantology and Dental surgery motor unit lmpulsion K102241

# anthogyr

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

## 1. GENERAL INFORMATION

| Submitter | ANTHOGYR (Registration number 8020776) |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 2237 avenue André Lasquin |
| | 74700 SALLANCHES FRANCE |
| | Phone: [phone] Fax: [phone]<br>Web : www.anthogyr.com |
| Contacts | Sabine BRAYETTE (QUALITY ENGINEER IN CHARGE OF<br>REGULATORY AFFAIRS)<br>[e-mail] |
| Trade Name | Anthogyr « Implanteo » implantology and dental surgery<br>motor unit |
| Legally marketed<br>predicate devices | ANTHOGYR Implanteo (K041279) - ANTHOGYR contra-<br>angle (K090676)<br>BIEN-AIR CHIROPRO L (K092214) -<br>W&H implantMED (K052741) |
| Classification Name | Dental handpieces and accessories |
| Class | I |
| Product Code | EBW |
| CFR section | 872.4200 |
| Intended Use | ✓ IMPLANTEO implantology and dental surgery motor<br>unit are indicated to perform dental implant surgery,<br>such as perforating the bone and tapping and<br>threading procedures required before placement of<br>implant prosthetics. |

## 2. INTENDED USE

IMPLANTEO implantology and dental surgery motor unit are indicated to perform dental implant surgery, such as perforating the bone and tapping and threading procedures required before placement of implant prosthetics.

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510{k) – « IMPLANTEO » Implantology and Dental surgery motor unit lmpulsion K102241

anthoevr

#### 3. DEVICE DESCRIPTION

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

The ANTHOGYR "IMPLANTEO" implantology and dental surgery motor unit consist of design improvement of non essential characteristics of the device. The ANTHOGYR "IMPLANTEO" implantology and dental surgery motor unit has the same fundamental scientific technology, operating principle and intended use as ANTHOGYR IMPLANTEO (K041279) with ANTHOGYR implantology contra-angle (K090676) or BIEN-AIR CHIROPRO L (K092214) with NSK contra-angle (K970953) or W&H implantMED (K052741) with contra-angle (K080939).

#### 4. PERFORMANCE DATA

ANTHOGYR Contra angles & Handpieces conform to the following FDA recognized Consensus standards:

- > I 50 15223-1 (2007) *Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied" (Recognition number 5-31)
- V IEC 11498 (1997) "Dental Handpieces : Dental low-voltage electrical motors" (Recognition number 4-83)
- ✓ IEC 60601-1 (2005) *Medical Electrical Equipment Part 1 : General Requirements for safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995" (Recognition number 5-4)
- V IEC 60601-1-2 (2001) "Medical Electrical Equipment part 1-2 : General Requirements for safety - collateral standard : Electromagnetic Compatibility -Requirements and tests" (Recognition number 5-34)
- ✔ ISO 7785-2 (1998) "Dental Handpieces Part 2: Straight and geared angle handpieces" (Recognition number 4-76)
- V ISO 3964 (1982) "Dental Handpieces Coupling dimensions" (Recognition List Number: 003 Effective Date: 05/03/1999)

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510(k) – « IMPLANTEO » Implantology and Dental surgery motor unit anthogyr Impulsion K102241

In addition, ANTHOGYR « IMPLANTEO » implantology and dental surgery motor unit and ANTHOGYR Contra angles conform to the following standards:

- I ISO 14971 (2007) "Medical devices Application of risk management to medical devices" (Recognition number : 5-40)
- I SO 13485 (1996) "Medical devices Particular requirements for the application of the ISO 9001"
- V NF EN ISO 1797-1 (1995) "Dental rotatory instruments Shanks Par 1: Shanks made of metal"
- V NF EN ISO 17664 (2004) « Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices »

### 5. SUBSTANTIAL EQUIVALENCE

The ANTHOGYR « IMPLANTEO » implantology and dental surgery motor unit have the same fundamental scientific technology, operating principle and intended use as predicate devices.

Summary preparation date: February 1, 2011

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

Ms. Brayette Sabine Quality Engineer Anthogyr ASA 2237, Avenue Andre Lasquin Sallanches, France 74700

MAR 2 3 201

Re: K102241

Trade/Device Name: ANTHOGYR "IMPLANTEO" IMPLANTOLOGY AND DENTAL SURGERY MOTOR UNIT Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EBW Dated: March 14, 2011 Received: March 18, 2011

Dear Ms. Sabine:

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. Sabine

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 (OS) 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,

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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510(k) - « IMPLANTEO » Implantology and Dental surgery motor unit Impulsion K102241

anthogyr

Indications for Use

K10224|

510(k) Number (if known):

Device Name: ANTHOGYR "IMPLANTEO" IMPLANTOLOGY AND DENTAL SURGERY MOTOR UNIT

Indications for Use:

ANTHOGYR's IMPLANTEO implantology and dental surgery motor unit are indicated to perform dental implant surgery, such as perforating the bone and tapping and threading procedures required before placement of implant prosthetics.

Prescription Use _ Over-The-Counter Use × AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

Concurrence of (CDRH) Office of Device Evaluation (ODE)

Susen Karr

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

510(k) Number: K102241