(99 days)
Not Found
No
The device description and intended use describe a mechanical dental handpiece powered by compressed air. There is no mention of software, algorithms, or data processing that would indicate the presence of AI/ML. The performance studies are based on mechanical standards (ISO 7785-1 and ISO 9168).
No.
The device is used for mechanical dental procedures like removing carious material and polishing teeth, which are not considered therapeutic interventions aimed at curing or treating a disease.
No
The device is intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations, and polishing teeth, which are all treatment and restoration functions, not diagnostic ones.
No
The device description clearly states it is a hand-held, channeled instrument made of metal parts (turbine, connector, internal tubes) and powered by compressed air. This indicates it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for mechanical procedures on teeth (removing material, preparing cavities, finishing, polishing). This is a direct intervention on the patient's body.
- Device Description: The description details a mechanical handpiece powered by air, designed to hold a dental bur for physical manipulation of tooth structure.
- 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, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are used in vitro (outside the body).
This device is a dental handpiece, which is a surgical/dental instrument used for procedures performed in vivo (within the body).
N/A
Intended Use / Indications for Use
Airlight Dental Handpiece, models M600 and M800 are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
Airlight Dental Handpiece Series, models M600 are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
Product codes (comma separated list FDA assigned to the subject device)
EFB
Device Description
The Airlight Dental Handpiece is a high speed dental handpiece with a lightly textured finish for enhanced grip. It is a hand-held, channeled instnument that is powered by compressed air that is delivered through a hose to an air channel is the handpiece. This impels the turbine in the head of the handpiece to nevolve in Other internal channels deliver air and water to the head for cleaning and cooling. Any common dental bur is held in place in the handpiece head by a push-buttong
There are three major parts which are made metal: a standard turbine, the threaded connector at the back end which attaches to the standard air/water hose in the dental unit, and the internal tubes that carry the chip air and water. The new three parts are substantially equivalent to those in the predicate device.
Similar to the predicate device, the Airlight Dental Handpiece must be cleaned and lubricated with a quality commercial dental handpiece cleaner/lubricant. It is supplied non-sterile, but must be sterilized before use, as with the predicate device. It will be packaged as a single unit or in multiples.
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)
The performance of Airlight Dental Handpiece following ISO 7785-1:1997 and ISO 9168:1991 were conducted.
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.
K052822, K062812, K062740, K093084, K063110, K021250, K101551
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
KI12623
510(k) Summary
Summary Prepared Date: 11/21/2011
Submission Sponsor:
Beves Dental Canada Inc. 595 Middlefield Road Unit 9, Toronto, M1V 3S2 Canada
Mr. Ted Thompson Toll Free: 1-877-703-3562 info@beves.ca
Submission Correspondent:
Mr. Anthony Hopkins Requlatory Affairs Specialist
Mr. Leon Lu Director of Quality and Regulatory Affairs
MEDevice Services, LLC 3500 South Dupont Highway Dover, Delaware 19901 USA Phone: 1-877-202-1588 Fax: 1-888-202-8884 Email: medeviceservices@gmail.com www.medeviceservices.com
Trade/Device Name: Airlight Dental Handpiece Series, models M600 and M800
Common or Usual Name: handpiece, air-powered, dental Device Class: 1 Classification Name: handpiece, air-powered, dental Regulation Number: 21 CFR 872.4200 Product Code: EFB Review Panel: Dental
1
Predicate Device:
- K052822, THUNGER TIGER CORP. ● TIGER 100, TIGER 101, TIGER 200, TIGER 201, TIGER 202
- K062812, THUNGER TIGER CORP. . TIGER 300T, TIGER 300K, TIGER 300W, TIGER 300B, TIGER 300N
- K062740, JINDELL MEDICAL INSTRUMENTS CO., LTD. . JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU
- K093084, ROLENCE ENT INC. � ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP
- K063110, SHANGHAI DENTAL INSTRUMENT FACTORY . CST61 HIGH SPEED TURBINE HANDPIECE
- K021250, MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 ● HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD)
- K101551, DELMA MEDICAL INSTRUMENT (GUANGZHOU) CO., LTD. ● PACEMAKER HIGH-SPEED HANDPIECE, MODELS PM-MQ AND PM-M
Device Description:
The Airlight Dental Handpiece is a high speed dental handpiece with a lightly textured finish for enhanced grip. It is a hand-held, channeled instnument that is powered by compressed air that is delivered through a hose to an air channel is the handpiece. This impels the turbine in the head of the handpiece to nevolve in Other internal channels deliver air and water to the head for cleaning and cooling. Any common dental bur is held in place in the handpiece head by a push-buttong
There are three major parts which are made metal: a standard turbine, the threaded connector at the back end which attaches to the standard air/water hose in the dental unit, and the internal tubes that carry the chip air and water. The new three parts are substantially equivalent to those in the predicate device.
Similar to the predicate device, the Airlight Dental Handpiece must be cleaned and lubricated with a quality commercial dental handpiece cleaner/lubricant. It is
2
supplied non-sterile, but must be sterilized before use, as with the predicate device. It will be packaged as a single unit or in multiples.
Intended Use:
Airlight Dental Handpiece, models M600 and M800 are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
Comparison to Predicate Devices:
The Airlight Dental Handpiece is essentially the same as or similar to the predicate device in terms of the intended use, design and construction, performance characteristics. The materials used are well-known biocompatible, so no new issues of biocompatibility are raised with regard to this device.
Discussion of Non-Clinical Tests Performed:
The performance of Airlight Dental Handpiece following ISO 7785-1:1997 and ISO 9168:1991 were conducted.
Discussion of Clinical Tests Performed:
None
Conclusion:
The proposed device has the same intended uses and indications, similar technological characteristics, and principles of operation as its predicate device. Thus, the Airlight Dental Handpiece, models M600 are substantially equivalent to its predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 1 6 2011
Beves Dental Canada Incorporated C/O Mr. Anthony Hopkins Regulatory Affairs Specialist MEDevice Services, LLC 3500 South Dupont Highway Dover, Delaware 19901:
- Re: K112623
Trade/Device Name: Airlight Dental Handpiece Series, Models M600 and M800 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: November 21, 2011 Received: December 12, 2011
Dear Mr. Hopkins:
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.
4
Page 2 - Mr. Hopkins
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 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/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/ReportalProblem /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.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
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
Enclosure
5
Indications for Use
510(k) Number (if known): K ( 1 86 2 3
Device Name: Airlight Dental Handpiece Series, models M600 and M800
Indications for Use:
Airlight Dental Handpiece Series, models M600 are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
Prescription Use メ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Russe
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K112623