(70 days)
ANTHOGYR's fully autoclavable contra-angles Implantology "MontBlanc" and ANTHOGYR's fully autoclavable contra-angles "MontBlanc" are devices intended for a wide range of dental procedures including:
Implant surgery such as perforating the bone, tapping and threading procedures
General dentistry such as removing carious material, cavity and crown preparation, finishing tooth preparations, restaurations and polishing teeth.
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 NF EN ISO 7785-2 Dental Handpieces -Part 2: Straight and geared angle handpieces".
ANTHOGYR has developed a full range of general dentistry contra angle intended to be used in general dentistry. The name of the range is "MontBlanc". ANTHOGYR Contra anales design, size and performance conform to NF EN ISO 7785-2 "Dental Handpieces - Part 2: Straight and geared anale handbieces".
The provided text describes a 510(k) premarket notification for "ANTHOGYR DENTAL CONTRA-ANGLES." This document focuses on demonstrating substantial equivalence to predicate devices and adherence to recognized standards, rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the format requested.
Therefore, much of the requested information regarding acceptance criteria, specific study details, and performance data from a clinical or extensive bench study is not available within this document. The submission relies on compliance with established international standards for dental handpieces and risk management.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The acceptance criteria are implicitly defined by compliance with the referenced international standards. The document states that "ANTHOGYR Contra angles design, size and performance conform to NF EN ISO 7785-2 Dental Handpieces -Part 2: Straight and geared angle handpieces." Other standards listed (ISO 14971, ISO 15223, ISO 13402, ISO 3964, ISO 5832-1, ISO 13485, NF EN ISO 1797-1, NF EN ISO 17664, NF EN ISO 17665-1) also serve as acceptance criteria for various aspects like risk management, labeling, resistance to autoclaving/corrosion, coupling dimensions, and material properties.
- Reported Device Performance: The document generally states that the devices conform to these standards. It does not provide specific quantitative performance metrics (e.g., torque values, RPMs, durability cycles, temperature ranges, or specific sterilization effectiveness rates) from a dedicated study that would allow a direct comparison to numerical acceptance thresholds.
| Aspect of Performance | Acceptance Criteria (Implicit from Standards) | Reported Device Performance |
|---|---|---|
| Design, Size, Performance | Conformance to NF EN ISO 7785-2 (2008) "Dental handpieces -- Part 2: Straight and geared angle handpieces" | Devices "conform to NF EN ISO 7785-2" |
| Risk Management | Conformance to ISO 14971 (2007) "Medical devices - Application of risk management to medical devices" | Devices "conform to ... ISO 14971" |
| Labeling | Conformance to ISO 15223 (2007) "Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied" | Devices "conform to ... ISO 15223" |
| Autoclaving, Corrosion, Thermal Exposure Resistance | Conformance to ISO 13402 (2007) "Surgical and dental hand instruments Determination of resistance against autoclaving, corrosion and thermal exposure" | Devices "conform to ... ISO 13402" |
| Coupling Dimensions | Conformance to ISO 3964 (1982) "DENTAL HANDPIECES COUPLING DIMENSIONS" | Devices "conform to ... ISO 3964" |
| Metallic Materials | Conformance to ISO 5832-1 (2008) "IMPLANTS FOR SURGERY -- METALLIC MATERIALS -> PART 1: WROUGHT STAINLESS STEEL" | Devices "conform to ... ISO 5832-1" |
| Quality Management System | Conformance to ISO 13485 (2004) "Medical devices - Particular requirements for the application of the ISO 9001" | Devices "conform to ... ISO 13485" |
| Rotating Instruments Shanks | Conformance to NF EN ISO 1797-1 (1995) "Dental rotatory instruments - Shanks - Par 1: Shanks made of metal" | Devices "conform to ... NF EN ISO 1797-1" |
| Sterilization Instructions (Manufacturer Provided) | Conformance to NF EN ISO 17664 (2004) "Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices" | Devices "conform to ... NF EN ISO 17664" |
| Sterilization Process (Moist Heat) | Conformance to NF EN ISO 17665-1 (2006) "Sterilization of health care products Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices" | Devices "conform to ... NF EN ISO 17665-1" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided in the document. The submission refers to compliance with standards, implying that testing was conducted according to the methodologies prescribed within those standards, but doesn't specify the sample sizes or data provenance for each test.
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)
- This information is not applicable/provided. The submission is not for an AI/diagnostic device that requires expert ground truth establishment for a test set. It's for a dental handpiece, where ground truth would relate to physical and mechanical properties measurable against defined standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable/provided. As above, this type of adjudication is typically for subjective assessments in AI or diagnostic studies, not for the objective physical/mechanical testing implied by compliance with ISO standards for a dental handpiece.
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
- This information is not applicable/provided. This is a medical device for general dental and implantology procedures (contra-angles), not an AI-assisted diagnostic or imaging system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable/provided. This is a mechanical dental instrument, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device would be the specifications and requirements stipulated by the referenced international standards (e.g., specific dimensions, material compositions, resistance levels, torque outputs, sterilization efficacy as defined by the standards). These are objective, measurable criteria, not subjective expert assessments or pathology findings.
8. The sample size for the training set
- This information is not applicable/provided. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- This information is not applicable/provided. As above, this is not an AI/machine learning device.
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SPECIAL 510(k) -- MODIFICATION TO K060317 AND K070084 ANTHOGYR DENTAL CONTRA-ANGLES
K090676
anthogyr
██████
MAY 22 2009
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 | Sabine BRAYETTE (QUALITY ENGINEER IN CHARGE OFREGULATORY AFFAIRS) sabine.brayette.prod@anthogyr.com |
| Trade Names | 1 - Anthogyr Contra angles « MontBlanc » |
| 2 - Anthogyr Implantology Contra-angles "MontBlanc" | |
| Legally marketedpredicate devices | 1. Anthogyr Contra angles « MontBlanc » K060317 |
| 2. Anthogyr Implantology Contra-angles "MontBlanc"Control K070084 | |
| Classification Name | Dental handpiece and accessories |
| Class | I |
| Product Code | EFA |
| CFR section | 872.4200 |
| Intended Use | ANTHOGYR'S fully autoclavable contra-anglesImplantology "MontBlanc" are devices intended for a widerange of dental procedures including:✓ Implant surgery such as perforating the bone, tappingand threading proceduresANTHOGYR's fully autoclavable contra-angles "MontBlanc"are devices intended for a wide range of dentalprocedures including:✓ General dentistry such as removing carious material,cavity and crown preparation, finishing toothpreparations, restaurations and polishing teeth. |
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2. INTENDED USE
ANTHOGYR's fully autoclavable contra-angles Implantology "MontBlanc" 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.
ANTHOGYR's fully autoclavable contra-angles "MontBlanc" are devices intended for a wide range of dental procedures including: -
General dentistry such as removing carious material, cavity and crown preparation, finishing tooth preparations, restaurations and polishing teeth.
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 NF EN ISO 7785-2 *Dental Handpieces -Part 2: Straight and geared angle handpieces".
ANTHOGYR has developed a full range of general dentistry contra angle intended to be used in general dentistry. The name of the range is "MontBlanc". ANTHOGYR Contra anales design, size and performance conform to NF EN ISO 7785-2 "Dental Handpieces - Part 2: Straight and geared anale handbieces".
4. PERFORMANCE DATA
ANTHOGYR Contra angles & Handpieces conform to the following FDA recognized Consensus standards:
-
ISO 14971 (2007) Medical devices - Application of risk management to medical devices (Recognition List Number: 018 Effective Date: 09/12/2007)
-
ISO 15223 (2007) Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied (Recognition List Number: 017 Effective Date: 05/21/2007)
- V ISO 13402 (2007) Surgical and dental hand instruments Determination of resistance against autoclaving, corrosion and thermal exposure.(Recognition List Number: 017 Effective Date: 05/21/2007)
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Image /page/2/Picture/1 description: The image shows the logo for Anthogyr Dental Care by Nature. The word "anthogyr" is written in a cursive font. Below the word is a row of five black squares, and below that is the phrase "DENTAL CARE BY NATURE" in a smaller, blocky font.
-
ISO 7785-2 (2008) Dental handpieces -- Part 2: Straight and geared angle handpieces (Recognition List Number: 020 Effective Date: 07/31/2008)
- ISO 3964 (1982) DENTAL HANDPIECES COUPLING DIMENSIONS (Recognition > List Number: 003 Effective Date: 05/03/1999)
- ISO 5832-1 (2008) IMPLANTS FOR SURGERY -- METALLIC MATERIALS -> PART 1: WROUGHT STAINLESS STEEL (Recognition List Number: 020 Effective Date: 07/31/2008)
In addition, ANTHOGYR Contra angles & Handpieces conform to the following standards:
-
ISO 13485 (2004) "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"
-
NF EN ISO 17664 (2004) « Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices »
- NF EN ISO 17665-1 (2006) « Sterilization of health care products Moist heat > - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices »
5. SUBSTANTIAL EQUIVALENCE
The Implantology Contra-angles "Mont Blanc" have the same fundamental scientific technology, operating principle and intended use as predicate devices.
The Contra-angles "Mont Blanc" have the same fundamental scientific technology, operating principle and intended use as predicate devices.
Summary preparation date: February 19, 2009
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sabine Brayette Quality Engineer in Charge of Regulatory Affairs Anthogyr 2237 Avenue André Lasquin Sallanches FRANCE 74700
MAY 22 2009
Re: K090676
Trade/Device Name: Anthogyr Contra Angles and Handpieces Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFA Dated: April 24, 2009 Received: April 29, 2009
Dear Sabine Brayette:
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 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.
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
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Page 2- Sabine Brayette
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runne
Susan Runner, D.D.S., MA Acting 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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thogyr
DENTAL CARE BY NATURE
Indications for Use
510(k) Number (if known): K090676
Device Name: ANTHOGYR CONTRA ANGLES AND HANDPIECES
-
fully Use: ANTHOGYR's autoclavable contra-angles Indications for > Implantology "MontBlanc" and ANTHOGYR's fully autoclavable contra-angles "MontBlanc" are devices intended for a wide range of dental procedures including:
Implant surgery such as perforating the bone, tapping and threading procedures V -
General dentistry such as removing carious material, cavity and crown preparation, finishing tooth preparations, restaurations and polishing teeth.
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)
Kein Muluy for MSP
(Division Sign-Jitt) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090676
Page 1 of 1
Page 43/54
§ 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.