ANTHOGYR CONTRA ANGLES AND HANDPIECES

K060317 · Est. Anthogyr · EGS · Apr 28, 2006 · Dental

Device Facts

• Record ID: K060317
• Device Name: ANTHOGYR CONTRA ANGLES AND HANDPIECES
• Applicant: Est. Anthogyr
• Product Code: EGS · Dental
• Decision Date: Apr 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

ANTHOGYR's fully autoclavable contra-angles "MontBlanc" are devices intended for a wide range of dental procedures including: - Implant surgery such as perforating the bone, tapping and threading procedures - General dentistry such as removing carious material, cavity and crow preparation, finishing tooth preparations, restorations and polishing teeth

Device Story

MontBlanc contra-angles are dental handpieces used by dentists for implantology and general restorative procedures. Devices are mechanical, autoclavable instruments designed to hold and rotate dental burs or surgical tools. Operation involves coupling to a dental motor to provide rotational power for bone perforation, tapping, threading, or tooth preparation. Used in clinical dental settings. Output is the mechanical action of the attached tool on dental or bone tissue, enabling the clinician to perform surgical or restorative tasks. Benefits include precise tissue removal and preparation during dental procedures.

Clinical Evidence

Bench testing only. Device performance validated through conformity to recognized consensus standards, including ISO 7785-2 (Dental Handpieces), ISO 13402 (resistance to autoclaving/corrosion), and ISO 7153-1 (stainless steel materials).

Technological Characteristics

Contra-angle handpieces constructed of stainless steel (ISO 7153-1). Geared angle design per ISO 7785-2. Fully autoclavable. Mechanical operation via coupling to dental motor (ISO 3964).

Indications for Use

Indicated for dental patients requiring implant surgery (bone perforation, tapping, threading) or general dentistry procedures (caries removal, cavity/crown preparation, finishing, restoration, polishing).

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 Implantology Contra angles (K040674)
• Anthogyr General dentistry Contra angles (K040674)

Submission Summary (Full Text)

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SPECIAL 510(k) - MODIFICATION TO K040674 ANTHOGYR DENTAL CONTRA-ANGLES AND HANDPIECES

Image /page/0/Picture/1 description: The image shows the word "anthogyr" in a stylized font, followed by two black squares with white symbols inside. Below these elements, the text "K060317" is written in a handwritten style. The image appears to be a combination of printed text, symbols, and handwritten characters.

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENES

# 1. GENERAL INFORMATION

2 8 2006

| Submitter | ANTHOGYR (Registration number 802 0776)<br>164 rue des trois lacs<br>74700 SALLANCHES FRANCE<br>Phone: [phone] Fax: [phone] |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Contacts | Eric GENEVE (RD Manager) [e-mail]<br>Regulatory Affairs: Idée Consulting (Dr Isabelle DRUBAIX) [e-mail] |
| Common Name | Dental handpiece and accessories |
| Classification Name | Handpiece, Contra- and Right-angle attachment, dental |
| Class | I |
| Product Code | EFA |
| CFR section | 872.4200 |
| Device panel | DENTAL |
| Trade Names | 1. Anthogyr Implantology Contra-angle "MontBlanc"<br>2. Anthogyr General dentistry Contra angles "MontBlanc" |
| Legally marketed<br>predicate devices | 1. Anthogyr Implantology Contra angles K040674<br>2. Anthogyr General dentistry Contra angles K040674 |

### 2. INTENDED USE

ANTHOGYR's fully autoclavable contra-angles "MontBlanc" are devices intended for a wide range of dental procedures including:

- Implant surgery such as perforating the bone, tapping and threading procedures >
- > General dentistry such as removing carious material, cavity and crow preparation, finishing tooth preparations, restorations and polishing teeth

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Image /page/1/Picture/1 description: The image shows the word "anthogyr" in a bold, sans-serif font. Below the word, there are two small, square icons. The left icon contains a stylized image of a screw, while the right icon is a solid black square.

#### 3. DEVICE DESCRIPTION

ANTHOGYR has developed a full range of surgical, reducing, multiplying and 1:1 contra angle intended to be used in implantology and general dentistry procedures. The name of the range is "MontBlanc". ANTHOGYR Contra angles design, size and performance conform to NF EN ISO 7785-2 "Dental Handpieces - Part 2: Straight and geared angle handpieces.

#### 4. PERFORMANCE DATA

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

- > ISO 14971 (2001) *Medical devices - Application of risk management to medical devices" (Recognition List Number: 005 Effective Date: 05/04/2001)
- ISO 15223 (2000) « Medical devices Symbols to be used with medical device > labels, labeling and information to be supplied » (Recognition List Number: 008 Effective Date: 10/29/2003)
- > ISO 13402 (2002) « Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure » (recognized Recognition List Number: 001 Effective Date: 02/19/1998)
- > ISO 7785-2 (1995) "Dental Handpieces - Part 2: Straight and geared angle handpieces" (Recognition List Number: 003 Effective Date: 05/03/1999)
- ISO 3964 (1982) "Dental Handpieces Coupling dimensions" (Recognition List > Number: 003 Effective Date: 05/03/1999)
- ISO 7153-1 (1999) « Surgical instruments Metallic materials Part 1 : stainless > steel » (Recognition List Number: 006 Effective Date: 10/01/2001)

In addition, ANTHOGYR Contra angles & Handpieces conform to the following standards:

- ISO 13485 (1996) *Medical devices Particular requirements for the application of the ISO 9001"

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Image /page/2/Picture/1 description: The image shows the word "anthogyr" in a stylized font. Below the word are two black squares. The left square contains a white image of a screw.

- > NF EN ISO 1797-1 (1995) "Dental rotatory instruments - Shanks - Par 1: Shanks made of metal"
- > 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 modifications to ANTHOGYR Contra-angles (KO40674) consist of design improvement of non essential characteristics of the device. The modified ANTHOGYR Contra-angles "Mont Blanc" have the same fundamental scientific technology, operating principle and intended use as the predicate device.

Validation test included within this submission demonstrates safety, effectiveness and conformity to the FDA recognized consensus standard ISO 7785-2 (1995) "Dental Handpieces - Part 2: Straight and geared angle handpieces".

Summary preparation date: January 27, 2006

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with three parallel lines forming the snake and staff. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA".

2.27 2 8 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Eric Geneve Regulatory & Department Manager EST. Anthogyr 164. Rue Des Trois Lacs Sallanches, France 74700

Re: K060317

Trade/Device Name: Anthogyr Contra Angles and Handpieces Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EGS Dated: March 30, 2006 Received: April 14, 2006

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/industry/support/index.html.

Sincerely yours.

Clare L.

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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# SPECIAL 510(k) - MODIFICATION TO K040674 ANTHOGYR DENTAL CONTRA-ANGLES AND HANDPIECES

Image /page/5/Picture/1 description: The image shows the word "anthogyr" in a stylized font, with the "a" and "n" connected. Below the word are two small, dark squares. The left square contains a white image of a screw, while the right square contains a white image of a curved line with dots above and below it. The overall image appears to be a logo or brand mark.

## Indications for Use

510(k) Number (if known):

### Device Name: ANTHOGYR CONTRA ANGLES AND HANDPIECES

Indications for Use: ANTHOGYR's fully autoclavable contra-angles "MontBlanc" are devices intended for a wide range of dental procedures including:

- > Implant surgery such as perforating the bone, tapping and threading procedures
- V General dentistry such as removing carious material, cavity and crown preparation, finishing tooth preparations, restorations and polishing teeth

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

Over-The-Counter Use _ (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Super Rungs

Inav. Genera

K060317

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