(104 days)
Not Found
K/DEN numbers not found.
No
The 510(k) summary describes a mechanical handpiece attachment and contains no mention of AI, ML, or related concepts.
No
The device is used for dental procedures such as removing excess materials, preparation, finishing, and polishing, but it does not treat or prevent a disease, injury, or condition; it facilitates dental work.
No
The intended use describes procedures related to removing protrusions, finishing, polishing, stripping, vibrating inlays, and preparing root canals, which are all therapeutic or preparatory actions rather than diagnostic ones.
No
The device description clearly indicates a "reciprocating contra-angle handpiece attachment," which is a physical hardware component used in dentistry.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The description clearly states the device is a handpiece attachment used for mechanical procedures within the mouth (removing materials, preparation, finishing, polishing, stripping, vibrating, root canal preparation). These are all physical manipulations of tissues and materials in vivo (within the living body), not tests performed on samples in vitro (outside the living body).
The intended use and device description do not involve analyzing biological samples to diagnose or monitor a condition.
N/A
Intended Use / Indications for Use
The A-dec/W&H Synea Profin reciprocating contra-angle handpiece attachment is intended for use in removing protrusions or excess of filling materials and cements, preparation, finishing and polishing in the interdental and subgingival regions, stripping, vibrating of inlays using Dentatus tips and root canal preparations using endodontic files.
Product codes
EFB
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
interdental and subgingival regions
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird-like figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 7 2009
Mr. Thomas H. Louisell Regulatory Compliance Manager A-dec, Incorporated 2601 Crestview Drive Newberg, Oregon 97132-9257
Re: K082827
Trade/Device Name: A-dec/W&H Synea Profin Reciprocating Contra-Angle Handpiece Attachment WA-67/1.1 LT, WA-67/0.4 LT, WA-67/1.1 A, WA-67/0.4 A
Regulation Number: 21 CFR 872.4200
Regulation Name: Dental Handpiece and Accessories
Regulatory Class: I
Product Code: EFB
Dated: December 29, 2008
Received: January 5, 2009
Dear Mr. Louisell:
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.
1
Page 2 - Mr. Louisell
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 (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.
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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.
Susan Turner
Ginette Y. Michaud, M.D.
Ginette Y. Michaud, M. D. Division Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
INDICATIONS FOR USE
1 of 1 Page
510(k) Number (if known):_
Device Name:
A-dec/W&H Synea Profin reciprocating contra-angle handpiece attachment WA-67/1.1 LT, WA-67/0.4 LT, WA-67/1.1A, WA-67/0.4A
Indications For Use:
The A-dec/W&H Synea Profin reciprocating contra-angle handpiece attachment is intended for use in removing protrusions or excess of filling materials and cements, preparation, finishing and polishing in the interdental and subgingival regions, stripping, vibrating of inlays using Dentatus tips and root canal preparations using endodontic files.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
����������������������������������������������������������������������������������������������������������������������������������������������������������������������������� Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ﮯ (Per 21 CFR 801Subpart D) OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Susan Cuarres
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: