(107 days)
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 intended for use in a wide range of procedures including:
- Endodontic surgeries, such as root canal preparations
- Endodontic surgery such as perforating the bone, tapping and threading procedures
- Implant surgery such as perforating the bone, tapping and crown proper
- General dentistry such as removing carious material, cavity and crow preparation, finishing tooth preparations, restorations and polishing teeth
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.
This document describes a 510(k) premarket notification for ANTHOGYR DENTAL HANDPIECES. The 510(k) summary focuses on the device's adherence to voluntary consensus standards rather than presenting a performance study with specific acceptance criteria and detailed results from a study. Therefore, the information requested in your prompt regarding specific acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not available in the provided text.
The submission states: "ANTHOGYR Contra angles & Handpieces conform to the following voluntary Consensus standards." This indicates that the device's performance is demonstrated by its compliance with recognized industry standards, rather than through a bespoke clinical or non-clinical study designed to meet specific new acceptance criteria.
Information that can be extracted from the provided text, related to your request, is as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to NF EN ISO 7785-2 "Dental Handpieces - Part 2: Straight and geared angle handpieces." | The device design, size, and performance "conform to NF EN ISO 7785-2". |
| Conformance to "voluntary Consensus standards" (specific standards not explicitly listed but implied by the successful 510(k) clearance). | The device "conform[s] to the following voluntary Consensus standards". |
| Autoclavable for sterilization. | The device is "fully autoclavable". |
| Intended for use in implantology, endodontic surgeries, and general dentistry. | The device is "intended for a wide range of procedures including implantology, endodontic surgeries and general dentistry." |
2. Sample size used for the test set and the data provenance: Not provided. The submission relies on conformance to standards, not a specific test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" was established based on expert consensus for a test set in the manner of a clinical study, as the submission relies on standards conformance.
4. Adjudication method for the test set: Not applicable. No test set requiring adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a dental handpiece, not an AI-powered diagnostic tool. MRMC studies are irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical dental device, not an algorithm.
7. The type of ground truth used: Conformance to established international and voluntary consensus standards (e.g., NF EN ISO 7785-2) for dental handpiece design and performance.
8. The sample size for the training set: Not applicable. This is a physical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable.
Summary of Device Performance and Study:
The ANTHOGYR Dental Handpieces (including Surgi Control, Endo Micro NiTi & NiTi Control, and General dentistry Contra angles) received 510(k) clearance (K040674) based on their substantial equivalence to legally marketed predicate devices and their conformance to relevant voluntary consensus standards.
The primary "study" and "acceptance criteria" presented in the provided text revolve around the device's compliance with established industry standards for dental handpieces. Specifically, the submission states that the "ANTHOGYR Contra angles design, size and performance conform to NF EN ISO 7785-2 'Dental Handpieces - Part 2: Straight and geared angle handpieces.'" It also mentions conformance to other "voluntary Consensus standards." This means that the device was designed, manufactured, and tested to meet the specifications and performance requirements outlined in these standards, which are internationally recognized benchmarks for safety and effectiveness of dental handpieces.
However, the 510(k) summary does not detail the specific tests conducted, the sample sizes used for those tests, or the raw data from such tests. Instead, it asserts that the device conforms to these standards, which is sufficient for regulatory clearance under the 510(k) pathway for Class I devices like dental handpieces.
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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: 33(0)4 50 58 02 37Fax: 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 |
| ANTHOGYRTrade Names | 1. Surgi Control (Implantology Contra angles) |
| 2. Endo Micro NiTi & NiTi Control (Endodontic Contra angles) | |
| 3. General dentistry Contra angles | |
| Legally marketedpredicate 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:
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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 (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
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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)
§ 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.