(58 days)
Not Found
No
The summary describes a mechanical dental handpiece and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as a surgical instrument used for mechanical procedures like perforating bone, tapping, and threading, not for treating a condition or disease.
No
The device is described as a contra-angle for surgical dental procedures, specifically implant surgery, which involves performing actions like perforating bone and tapping/threading. It does not mention analyzing or interpreting data to determine a diagnosis.
No
The device description clearly states it is a "full range of surgical contra angle" and mentions physical characteristics and standards related to dental handpieces, indicating it is a physical hardware device.
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 for "Implant surgery such as perforating the bone, tapping and threading procedures." This is a surgical procedure performed directly on a patient's body.
- Device Description: The description refers to "surgical contra angle intended to be used in implantology." Again, this points to a surgical tool.
- Lack of IVD characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on in vitro analysis.
- Use in a laboratory setting for diagnostic purposes.
The device is clearly described as a surgical instrument used in dental implant procedures.
N/A
Intended Use / Indications for Use
ANTHOGYR's fully autoclavable contra-angles Implantology "MontBlanc" Control are devices intended for a wide range of dental procedures including: Implant surgery such as perforating the bone, tapping and threading procedures This range can be used with special accessories like depth stop.
Product codes
EFA
Device Description
ANTHOGYR has developed a full range of surgical contra angle intended to be used in implantology. The name of the range is "MontBlanc". ANTHOGYR Contra angles design, size and performance conform to N.F. 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Ko70084
SPECIAL 510(k) – MODIFICATION TO K040674 AND K060317 ANTHOGYR DENTAL CONTRA ANGLES
Image /page/0/Picture/3 description: The image shows the word "anthogyr" in a stylized font, with the "g" extending into the line below. Below the word are three square icons. The first icon is a square with a pattern of small squares inside. The second icon is a square with a spiral shape inside. The third icon is a square with a circular shape inside.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
·1. GENERAL INFORMATION
| Submitter | ANTHOGYR (Registration number 8020776) |
|---|---|
| 164 rue des trois lacs | |
| 74700 SALLANCHES FRANCE | |
| Phone: 33(0)4 50 58 02 37 Fax: 33(0)4 50 93 78 60 | |
| Web : www.anthogyr.com | |
| Contacts | Eric GENEVE (R&D Manager) e.geneve.rd@anthogyr.com |
| Trade Names | Anthogyr Implantology Contra-angle "MontBlanc" Control |
| (with depth stop) | |
| Legally marketed | |
| predicate devices | 1. Anthogyr Implantology Contra angles K040674 |
| 2. Anthogyr Contra angles K060317 | |
| Classification Name | Dental handpiece and accessories |
| Class | I |
| Product Code | EFA |
| CFR section | 872.4200 |
| Intended Use | ANTHOGYR's fully autoclavable contra-anglesImplantology |
| "MontBlanc" Control are devices intended for a wide range | |
| of dental procedures including: | |
| Implant surgery such as perforating the bone, tapping | |
| and threading procedures | |
| This range can be used with special accessories like depth | |
| stop. |
2. INTENDED USE
ANTHOGYR's fully autoclavable contra…angles Implantology "MontBlanc" Control are devices intended for a wide range of derital procedures including:
-
Implant surgery such as perforating the bone, tapping and threading procedures. This range can be used with special accessories like depth stop.
1
Image /page/1/Picture/1 description: The image shows the word "anthogyr" in a stylized font, followed by two small square logos. The first logo on the left contains a white spiral shape on a black background. The second logo on the right contains a white circle with a number 8 inside, also on a black background. The word "anthogyr" is in a serif font and appears to be slightly italicized.
3. DEVICE DESCRIPTION
ANTHOGYR has developed a full range of surgical contra angle intended to be used in implantology. The name of the range is "MontBlanc". ANTHOGYR Contra angles design, size and performance conform to N.F. 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 the supplied » (Recognition List Number: 008 Effective Date: 10/29/2003)
- V ISO 13402 (2002) « Surgical and dental hand instruments Determination of resistance against autoclaving, corrasion 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: 05/03/1:999)
-
ISO 7153-1 (1999) « Surgical instruments - Metallic materials - Part 1 : stainless steel » (Recognition List Number: 00: Effective Date: 10/01/2001)
In addition, ANTHOGYR Contra angle: & Handpieces conform to the following standards:
- ISO 13485 (1996) "Medical devices Particular requirements for the application > of the ISO 9001"
- NF EN ISO 1797-1 (1995) "Dental rotatory instruments Shanks Par 1: Shanks > made of metal"
2
Image /page/2/Picture/1 description: The image shows the word "anthogyr" in a stylized font at the top. Below the word, there are three small, square images. The first image on the left appears to be a blurry, abstract design. The middle image contains a clear depiction of a screw. The image on the right contains a circular design with some internal details.
-
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 addition of an option (already available in Surgicontrol in K040674) to ANTHOGYR contra-angles Implantology "MontBlanc" K060317 consist of design improvement of non essential characteristics of the device. The Implantulogy Contra-angles "Mont Blanc" Control have the same fundamental scientific technology, operating principle and intended use as predicate devices.
Summary preparation date: December 19, 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) of the United States. The seal features a circular design with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the perimeter. In the center of the seal is an abstract emblem resembling an eagle or a stylized human figure, composed of flowing lines. The emblem is black, providing a stark contrast against the white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Eric Geneve Industrial Manager Anthogyr 164, Rue Des Trois Lacs Sallanches, France 74700
MAR 0 8 2007
Re: K070084
Trade/Device Name: Anthogyr Implantology Contra-Angle "MontBlanc" Control Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFA Dated: December 29, 2006 Received: February 6, 2007
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.
4
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 (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.
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours.
Chiu-Liang Ph.D.
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
5
SPECIAL 510(k) -- MODIFICATION TO K04th674 AND K060317 ANTHOGYR DENTAL CONTRA-ANGLES
Image /page/5/Picture/1 description: The image shows the word "anthogyr" in a stylized font, with the "a" and "r" slightly larger than the other letters. Below the word are three small, square images. The first image on the left appears to be a starburst or radial pattern. The middle image shows a double helix, likely representing DNA. The image on the right contains a circular design with some internal markings.
Indications for Use
510(k) Number (if known): K07008
Device Name: ANTHOGYR CONTRA ANGLES AND HANDPIECES
- fully for ANTHOGYP's autoclavable contra-angles く Indications Use: Implantology "MontBlanc" Control are devices intended for a wide range of dental procedures including:
Implant surgery such as perforating the bone, tapping and threading procedures This range can be used with special accessaries like depth stop.
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)
Susan Pearson
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