IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES

K040674 · Anthogyr · EFA · Jun 30, 2004 · Dental

Device Facts

• Record ID: K040674
• Device Name: IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES
• Applicant: Anthogyr
• Product Code: EFA · Dental
• Decision Date: Jun 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

ANTHOGYR contra angles and handpieces are autoclavable devices intended for a wide range of procedures including implantology, endodontic surgeries and general dentistry.

Device Story

Device consists of range of reducing, multiplying, and 1:1 contra-angle and straight dental handpieces. Used by dental professionals in clinical settings for implantology, endodontic, and general dentistry procedures. Handpieces connect to dental units to provide mechanical rotation for burs, drills, or files. Autoclavable design allows for sterilization between patient uses. Provides mechanical power transmission for surgical and restorative tasks; assists clinicians in performing precise dental interventions.

Clinical Evidence

Bench testing only. Device conforms to NF EN ISO 7785-2 (Dental Handpieces - Part 2: Straight and geared angle handpieces).

Technological Characteristics

Reducing, multiplying, and 1:1 gear ratio contra-angle and straight handpieces. Design conforms to NF EN ISO 7785-2. Autoclavable. Mechanical transmission of rotational energy.

Indications for Use

Indicated for dental procedures including endodontic surgery (root canal preparation, bone perforation, tapping, threading), implant surgery (bone perforation, tapping, crown preparation), and general dentistry (removing carious material, cavity/crown preparation, finishing tooth preparations, restorations, and 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

• Aseptico Autoclavable Handpieces (K020137)
• Series Xe, Se, Te (Micro Mega) (K971350)

Submission Summary (Full Text)

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Ko40674

510(k) Premarket Notification ANTHOGYR DENTAL HANDPIECES

Image /page/0/Picture/3 description: The image shows the word "anthogyr" in a stylized font at the top. Below the word are three small squares. The first square on the left contains a black and white image of a dental implant. The middle square contains the word "anthogyr" in a smaller font. The square on the right is a solid black color.

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

## 1. GENERAL INFORMATION

| Submitter | ANTHOGYR (Registration number 802 0776) |
|---------------------------------------|----------------------------------------------------------------------------------------------------|
| | 164 rue des trois lacs |
| | 74700 SALLANCHES FRANCE |
| | Phone: [phone]<br>Fax: [phone] |
| Contacts | Eric GENEVE (RD Manager) [e-mail] |
| | 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 | 1 |
| Product Code | EGS |
| CFR section | 872.4200 |
| Device panel | DENTAL |
| ANTHOGYR<br>Trade Names | 1. Surgi Control (Implantology Contra angles) |
| | 2. Endo Micro NiTi & NiTi Control (Endodontic Contra angles) |
| | 3. General dentistry Contra angles |
| Legally marketed<br>predicate devices | 1. Aseptico Autoclavable Handpieces (Aseptico) K020137 |
| | 2. Aseptico Autoclavable Handpieces (Aseptico) K020137 |
| | 3. Aseptico Autoclavable Handpieces (Aseptico) K020137,<br>Series Xe, Se, Te (Micro Mega) K 971350 |

### 2. INTENDED USE

ANTHOGYR contra angles and handpieces are autoclavable devices intended for a wide range of procedures including implantology, endodontic surgeries and general dentistry.

# 3. DEVICE DESCRIPTION

ANTHOGYR has developed a full range of reducing, multiplying and 1:1 contra angle and right hand-piece intended to be used in implantology, endodontic and general dentistry procedures. 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 voluntary Consensus standards:

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 0 2004

Mr. Eric Geneve RD Manager Anthogyr 164 Rue Des 3 Lacs 74700 Sallanches FRANCE

Re: K040674

Trade/Device Name: ANTHOGYR Contra Angles and Handpieces Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFA Dated: March 8, 2004 Received: April 16, 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 and if ments as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as 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 premiance lieting the 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,

Clus

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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Image /page/3/Picture/0 description: The image shows the word "anthogyr" in a stylized font, with three small, square images below it. The first image on the left appears to be a textured or patterned design. The middle image contains a graphic that resembles a medical implant or a piece of dental equipment. The third image on the right is a solid black square.

510(k) Premarket Notification ANTHOGYR DENTAL HANDPIECES

510(k) Number (if known): K040674

Device Name: ANTHOGYR CONTRA ANGLES AND HANDPIECES

Indications for Use: ANTHOGYR's fully autoclavable contra-angles and handpieces are
s are and the may be including and charing including mulcations for See ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

- loos intentional surgeries, such as root canal preparations ribe
- Endodonic surgery such as perforating the bone, tapping and threading procedures
Implant surgery such as perforating the bone, tapping and crown proper -1
- Implant surgery such as performanly carious material, cavity and crow preparation,
General dentistry such as removing carious material, cavity and crow preparation, : finishing tooth preparations, restorations and polishing teeth

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suan Ruaser

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

510(k) Number: KC41674

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (PER 21 CFR 801.109) or

Over-the-Counter Use

(Optional Format 1-2-96)