(126 days)
Not Found
No
The device description and summary of performance studies focus on mechanical and physical characteristics and adherence to standards, with no mention of AI or ML.
Yes
The device, consisting of handpieces, is used for surgical applications like wisdom tooth extraction, bone removal, and osteotomy, which are therapeutic interventions aimed at treating a medical condition or improving a patient's health.
No
The device is described as surgical contra-angle and straight handpieces used for procedures like extractions, bone removal, and osteotomy, which are therapeutic interventions, not diagnostic ones.
No
The device description explicitly states that the device consists of physical handpieces (MontBlanc Surgical contra-angle handpieces and straight handpieces) with various physical characteristics and connections, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses are all related to surgical procedures in implantology and surgery, specifically involving mechanical actions on bone and teeth (hemisection, extraction, resection, bone removal, osteotomy, etc.). These are direct surgical interventions on the patient's body.
- Device Description: The device is described as handpieces with different mechanical specifications (reduction/multiplication rates, motor speed, tool types, etc.) and features (light options, water spray). These are tools used for physical manipulation during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical procedures.
N/A
Intended Use / Indications for Use
Indications are very widespread in the field of implantology and surgery. The mentioned handpieces have been developed especially for the following applications : - MontBlanc Surgical contra-angle handpiece : for e.g. hemisection, wisdom tooth extraction. - MontBlanc Surgical straight handpiece : for e.g. application in the area of the front teeth, root tip resection, bone removal, osteotomy on the upper and lower jaw, preprosthetic surgical osteoplasty, sequestrum removal, fenestration on the alveolar appendix, apical ventilation, bone osteoplasty, bone smoothing.
Product codes (comma separated list FDA assigned to the subject device)
EGS
Device Description
Contra-angle handpiece
Reference: 12200X, 12200XL, 12200XLED
Reduction / multiplication rate: 1 : 3
Colour code: Orange
Weight (g): 98
Light: NO (12200X), OPTIC FIBER (12200XL), LED (12200XLED)
Motor connection standard: ISO 3964 (12200X), ISO 3964 (type Intra-Matic Lux) (12200XL), ISO 3964 (type Intra-Matic Lux with anthogyr connexion system) (12200XLED)
Maximum motor speed (rpm): 40 000
Tool type according to NF EN ISO 1797-1: Type 3
Diameter of tools (mm) according to NF EN ISO 1797-1: 1.60
Maximum length recommended by Anthogyr (mm): 25
Maximum diameter of the active part of the tool recommended by Anthogyr (mm): 2
Water spray output according to ISO 7785-2 (ml/min): > 50
Straight handpiece
Reference: 12400X, 12400XLED
Reduction / multiplication rate: 1 :1
Colour code: blue
Weight (g): 125
Light: NO (12400X), LED (12400XLED)
Motor connection standard: ISO 3964 (12400X), ISO 3964 (type Intra-Matic Lux with anthogyr connexion system) (12400XLED)
Tool type according to NF EN ISO 1797-1: Type 1 ou 2
Diameter of tools (mm) according to NF EN ISO 1797-1: 2.35
Maximum length recommended by Anthogyr (mm): 65
Maximum diameter of the active part of the tool recommended by Anthogyr (mm): 10
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
jaw, front teeth, root tip, alveolar appendix
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)
MontBlanc Surgical contra-angle handpiece and straight handpiece conform to the following FDA recognized Consensus standards:
- ISO 15223-1 (2007) "Medical devices Symbols to be used with medical device labels, labeling and information to be supplied" (Recognition number 5-31)
- ISO 7785-2 (1998) "Dental Handpieces Part 2: Straight and geared angle handpieces" (Recognition number 4-76)
- ISO 3964 (1982) "Dental Handpieces Coupling dimensions" (Recognition List Number: 003 Effective Date: 05/03/1999)
- ISO 7405 Second edition 2008-12-15 "Dentistry Evaluation of biocompatibility of medical devices used in dentistry" (Recognition List Number : 022)
In addition, MontBlanc Surgical contra-angle handpiece and straight handpiece conform to the following standards:
- ISO 14971 (2007) "Medical devices Application of risk management to medical devices" (Recognition number : 5-40)
- 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"
- NF EN I50 17664 (2004) "Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices"
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.
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
510(k) ~ "MontBlanc" Surgical Contra-angle and Straight Handpiece anthogyr K111532
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
1. GENERAL INFORMATION
| Submitter | ANTHOGYR (Registration number 8020776) | ||||
|---|---|---|---|---|---|
| 2237 avenue André Lasquin | |||||
| 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 OF | ||||
| REGULATORY AFFAIRS) | |||||
| sabine.brayette.prod@anthogyr.com | |||||
| Trade Names | MontBlanc Surgical contra-angle handpiece and straight | ||||
| handpiece | |||||
| Legally marketed | |||||
| predicate devices | ANTHOGYR Contra-angle and Handpiece (K040674) | ||||
| ANTHOGYR MontBlanc Contra-angle (K090676) | |||||
| WH Surgical contra-angle Handpieces (K011061) | |||||
| WH Surgical contra-angle and straight handpiece (K080939) | |||||
| Classification Name | Dental handpieces and accessories | ||||
| Class | I | ||||
| Product Code | EGS | ||||
| CFR section | 872.4200 | ||||
| Intended Use | Indications are very widespread in the field of | ||||
| implantology and surgery. The mentioned handpieces have | |||||
| been developed especially for the following applications : |
- MontBlanc Surgical contra-angle handpiece : for e.g.
hemisection, wisdom tooth extraction. - MontBlanc Surgical straight handpiece : for e.g.
application in the area of the front teeth, root tip | | | | |
1
K1115352
510(k) – "MontBlanc" Surgical Contra-angle and Straight Handpiece anthogyr K111532
| jaw, preprosthetic surgical osteoplasty, sequestrum |
|---|
| removal, fenestration on the alveolar appendix, apical |
| ventilation, bone osteoplasty, bone smoothing. |
2. INTENDED USE
Indications are very widespread in the field of implantology and surgery. The mentioned handpieces have been developed especially for the following applications : - MontBlanc Surgical contra-angle handpiece : for e.g. hemisection, wisdom tooth extraction.
- MontBlanc Surgical straight handpiece : for e.g. application in the area of the front teeth, root tip resection, bone removal, osteotomy on the upper and lower jaw, preprosthetic surgical osteoplasty, sequestrum removal, fenestration on the alveolar appendix, apical ventilation, bone osteoplasty, bone smoothing.
3. DEVICE DESCRIPTION
| Reference | Contra-angle handpiece | Straight handpiece | ||||
|---|---|---|---|---|---|---|
| 12200X | 12200XL | 12200XLED | 12400X | 12400XLED | ||
| Reduction / multiplication | ||||||
| rate | 1 : 3 | 1 :1 | ||||
| Colour code | Orange | blue | ||||
| Weight (g) | 98 | 125 | ||||
| Light | NO | OPTIC FIBER | LED | NO | LED | |
| Motor connection | ||||||
| standard | ISO 3964 | ISO 3964 | ||||
| (type Intra- | ||||||
| Matic Lux) | ISO 3964 | |||||
| (type Intra- | ||||||
| Matic Lux with | ||||||
| anthogyr | ||||||
| connexion | ||||||
| system) | ISO 3964 | ISO 3964 | ||||
| (type Intra- | ||||||
| Matic Lux | ||||||
| with | ||||||
| anthogyr | ||||||
| connexion | ||||||
| system) | ||||||
| Maximum motor speed | ||||||
| (rpm) | 40 000 | |||||
| Tool type according to NF | ||||||
| EN ISO 1797-1 | Type 3 | Type 1 ou 2 |
2
510(k) - "MontBlanc" Surgical Contra-angle and Straight Handpiece anthogyr K111532
| Reference | Contra-angle handpiece | Straight handpiece | ||||
|---|---|---|---|---|---|---|
| 12200X | 12200XL | 12200XLED | 12400X | 12400XLED | ||
| Diameter of tools (mm) | ||||||
| according to NF EN ISO | ||||||
| 1797-1 | 1.60 | 2.35 | ||||
| Maximum length | ||||||
| recommended by | ||||||
| Anthogyr (mm) | 25 * | 65 * | ||||
| Maximum diameter of the | ||||||
| active part of the tool | ||||||
| recommended by | ||||||
| Anthogyr (mm) | 2 * | 10 * | ||||
| Water spray output | ||||||
| according to ISO 7785-2 | ||||||
| (ml/min) | > 50 |
(*) Suggested values. If using longer and wider diameter rotary instruments, the user is responsible for the correct choice of the operating conditions to prevent any risk to the patient or to a third person.
4. PERFORMANCE DATA
MontBlanc Surgical contra-angle handpiece and straight handpiece conform to the following FDA recognized Consensus standards:
- ✓ ISO 15223-1 (2007) *Medical devices Symbols to be used with medical device labels, labeling and information to be supplied" (Recognition number 5-31)
- ✔ ISO 7785-2 (1998) "Dental Handpieces Part 2: Straight and geared angle handpieces" (Recognition number 4-76)
- √ ISO 3964 (1982) *Dental Handpieces Coupling dimensions" (Recognition List Number: 003 Effective Date: 05/03/1999)
- V ISO 7405 Second edition 2008-12-15 "Dentistry Evaluation of biocompatibility of medical devices used in dentistry" (Recognition List Number : 022)
In addition, MontBlanc Surgical contra-angle handpiece and straight handpiece conform to the following standards:
- √ ISO 14971 (2007) *Medical devices Application of risk management to medical devices" (Recognition number : 5-40)
3
510(k) - "MontBlanc" Surgical Contra-angle and Straight Handpiece anthogyr K111532
-
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"
-
NF EN I50 17664 (2004) « Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices »
5. SUBSTANTIAL EQUIVALENCE
The ANTHOGYR MontBlanc Surgical contra-angle handpiece have the same fundamental scientific technology, operating principle as ANTHOGYR Contra-angles (K090676).
The ANTHOGYR MontBlanc Surgical contra-angle handpiece and straight handpiece have the same fundamental scientific technology, operating principle and intended use as W&H contra-angle handpiece and straight handpiece legally marketed (K011061).
The ANTHOGYR MontBlanc Surgical straight handpiece have fundamental scientific technology as ANTHOGYR Contra-anqles (K040674),
MontBlanc Surgical contra-angle handpiece and straight handpiece have the same fundamental scientific technology, operating principle and intended use as predicate devices.
Summary preparation date: September, 15th 2011
4
Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of a caduceus, which is a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and wings at the top.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Sabine Brayette Quality Engineer In Charge Of Regulatory Affairs Anthogyr Sas 2237 Avenue Andre Lasquin Sallanches France 74700
OCT - 7 2011
Re: K111532
Trade/Device Name: MontBlanc Surgical Contra-Angle Handpiece and Straight Handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: 1 Product Code: EGS Dated: September 28, 2011 Received: September 30. 2011
Dear Ms. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
5
Page 2 - Ms. Bravette
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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.ida.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
6
Indications for Use
anthogyr
KIII532 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: MontBlanc Surgical contra-angle handpiece and straight handpiece
Indications for Use:
Indications are very widespread in the field of implantology and surgery. The mentioned handpieces have been developed especially for the following applications :
-
MontBlanc Surgical contra-angle handpiece : for e.q. hemisection, wisdom tooth extraction.
-
MontBlanc Surgical straight handpiece : for e.g. application in the area of the front teeth, root tip resection, bone removal, osteotomy on the upper and lower jaw, preprosthetic surgical osteoplasty, sequestrum removal, fenestration on the alveolar appendix, apical ventilation, bone osteoplasty, bone smoothing.
AND/OR
Prescription Use_ (Part 21 CFR 801 Subpart D) Over-The-Counter Use_ (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K111532