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.

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: ".

AI/ML Overview

This document describes a Special 510(k) submission for a modification to existing ANTHOGYR dental contra-angles. The information provided focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study with detailed acceptance criteria and performance data for a novel AI/software device.

Therefore, many of the requested sections regarding AI/software performance will be marked as "Not Applicable" or "Information Not Provided," as this submission does not pertain to such a device.

Here's an analysis of the provided text based on your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (from recognized standards)	Reported Device Performance
Material & Design:
ISO 14971 (2001): Medical device risk management compliant	ANTHOGYR Contra angles & Handpieces conform.
ISO 15223 (2000): Medical device symbols compliant	ANTHOGYR Contra angles & Handpieces conform.
ISO 13402 (2002): Resistance against autoclaving, corrosion, thermal exposure	ANTHOGYR Contra angles & Handpieces conform.
ISO 7153-1 (1999): Surgical instruments - Metallic materials - Part 1: Stainless steel	ANTHOGYR Contra angles & Handpieces conform.
ISO 13485 (1996): Quality management system (specific to medical devices) compliant	ANTHOGYR Contra angles & Handpieces conform.
Performance (Mechanical/Functional):
ISO 7785-2 (1995): Dental Handpieces - Part 2: Straight and geared angle handpieces	ANTHOGYR Contra angles design, size and performance conform to N.F. EN ISO 7785-2.
ISO 3964 (1982): Dental Handpieces - Coupling dimensions	ANTHOGYR Contra angles & Handpieces conform.
NF EN ISO 1797-1 (1995): Dental rotatory instruments Shanks Part 1: Shanks made of metal	ANTHOGYR Contra angles & Handpieces conform.
Sterilization:
NF EN ISO 17664 (2004): Information for processing resterilizable medical devices	ANTHOGYR Contra angles & Handpieces conform.
Substantial Equivalence:
Same fundamental scientific technology, operating principle, and intended use as predicate devices (K040674 and K060317).	The modification (addition of a depth stop option) is a design improvement of non-essential characteristics, maintaining the same fundamental scientific technology, operating principle, and intended use.

Explanation: The acceptance criteria are primarily based on conformity to recognized international and national standards for dental handpieces and medical device quality management. The reported performance is a general statement that the device "conforms" to these standards. There are no numerical performance metrics or specific test results detailed in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not Applicable. This submission describes a modification to a mechanical medical device (dental contra-angle), not a software or AI device that would typically have a "test set" in the context of diagnostic performance. Technical aspects are evaluated against engineering standards.
Data Provenance: Not Applicable. The data provided refers to conformity with manufacturing and performance standards, not to clinical data or AI model output.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not Applicable. Ground truth as typically understood for AI/software devices (e.g., diagnostic labels) is not relevant here. Compliance with engineering standards is verified through testing and certifications, not expert annotation of a test set.
Qualifications of Experts: Not Applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not Applicable.

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

MRMC Study: No. This is a mechanical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not Applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: The "ground truth" for this type of device is compliance with established engineering and safety standards (e.g., ISO, NF EN standards) for mechanical performance, material properties, and quality systems. This is verified through testing procedures outlined within those standards, often conducted by manufacturers or certified testing bodies, rather than clinical outcomes or pathology data.

8. The sample size for the training set

Sample Size for Training Set: Not Applicable. This is not an AI/machine learning device; there is no training set.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not Applicable.

Summary

{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 marketedpredicate 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

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

{3}------------------------------------------------

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

Page 1 of 1

K070084

Regulation Number and Section

§ 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.