(107 days)
K020137, K 971350
Not Found
No
The summary describes mechanical dental handpieces and contra angles, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device is a dental handpiece used for various dental procedures, such as removing carious material and preparing cavities, which are interventional rather than directly therapeutic in the sense of treating a disease or condition with a medical substance or process.
No
The device, ANTHOGYR contra angles and handpieces, is described as an autoclavable tool intended for performing various dental procedures (e.g., implantology, endodontic surgeries, general dentistry) rather than for diagnosing conditions. Its function is to perform actions on the teeth and bone, not to gather information for diagnosis.
No
The device description explicitly states "ANTHOGYR has developed a full range of reducing, multiplying and 1:1 contra angle and right hand-piece," which are physical hardware components used in dental procedures.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for various dental procedures within the patient's mouth (implantology, endodontic surgeries, general dentistry). IVDs are used to examine specimens outside the body (in vitro) to provide information about a patient's health.
- Device Description: The description details a mechanical device (contra angles and handpieces) used for drilling, cutting, and polishing teeth and bone. This is consistent with a surgical or procedural device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
Therefore, the ANTHOGYR contra angles and handpieces are dental surgical/procedural devices, not IVDs.
N/A
Intended Use / Indications for Use
ANTHOGYR contra angles and handpieces are autoclavable devices intended for a wide range of procedures including implantology, endodontic surgeries and general dentistry.
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
Product codes (comma separated list FDA assigned to the subject device)
EGS, EFA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
ANTHOGYR Contra angles & Handpieces conform to the following voluntary Consensus standards:
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K020137, K 971350
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.4200 Dental handpiece and accessories.
(a)
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.(b)
Classification. Class I.
0
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: 33(0)4 50 58 02 37 | |
| Fax: 33(0)4 50 93 78 60 | |
| Contacts | Eric GENEVE (RD Manager) e.geneve.rd@anthogyr.com |
| Regulatory Affairs: Idée Consulting (Dr Isabelle DRUBAIX) | |
| idrubaix@nordnet.fr | |
| 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 | |
| Trade Names | 1. Surgi Control (Implantology Contra angles) |
| 2. Endo Micro NiTi & NiTi Control (Endodontic Contra angles) | |
| 3. General dentistry Contra angles | |
| Legally marketed | |
| predicate devices | 1. Aseptico Autoclavable Handpieces (Aseptico) K020137 |
| 2. Aseptico Autoclavable Handpieces (Aseptico) K020137 | |
| 3. Aseptico Autoclavable Handpieces (Aseptico) K020137, | |
| 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:
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
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.
2
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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 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
3
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)