(73 days)
Not Found
Not Found
No
The summary describes a dental operative unit with motorized functions and a digital control system, but there is no mention of AI or ML capabilities.
No
The device is described as a dental operative unit and patient chair, providing a base and power for other dental devices, and positioning a patient for procedures. It does not exert any direct therapeutic effect on the patient.
No
The device is described as a "dental operative unit" that supplies power to and serves as a base for other dental devices and accessories, and includes a patient chair for positioning. There is no mention of the device being used to diagnose conditions, analyze medical data, or provide diagnostic information.
No
The device description clearly states it is a "dental operative unit including a dental patient chair" and is an "ACpowered device". 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 states that the Planmeca Sovereign is a "dental operative unit" used to "supply power to and serve as a base for other dental devices and accessories" and includes a "dental patient chair" for positioning patients during dental procedures. This describes a device used in vivo (on a living patient) for dental treatment and procedures.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The Planmeca Sovereign does not perform any such tests on biological samples.
- Device Description: The description focuses on the physical components and functions of a dental chair and unit, not on analyzing biological samples.
Therefore, the Planmeca Sovereign is a medical device used for dental procedures, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Planmeca Sovereign is a dental operative unit, which is an AC-powered device that is intended to supply power to and serve as a base for other dental devices and accessories. The device includes a dental patient chair, which is intended to properly position a patient to perform different dental procedures. The device is to be operated and used by dentists and other legally qualified professionals.
Product codes
EIA
Device Description
The Planmeca Sovereign is a dental operative unit including a dental patient chair. The design is very flexible with many motorized functions, and both left-handed and right-handed use is easily obtainable. The dentist and assistant are allowed to change their working postures according to the operation to be performed. The versatile swivelling enables fluent two-handed and four-handed treatment sequences. The unit is equipped with a digital control system with graphical user interface (GUI) to offer ease-of-use. The instrument console includes six instrument locations, with easy instrument interchange.
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
The device is to be operated and used by dentists and other legally qualified professionals.
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
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.
0
PLANMECA
Encl. 12 Page 12-1
510K) SUMMARY
DATE
June 13, 2008
AUG 29 2006
:
PRODUCT, CLASSIFICATION NAME
Trade name: Planmeca Sovereign Common name: Dental unit with patient chair Classification: EIA, Class I Regulation number: 872.6640 + 872.6250
MANUFACTURER
Planmeca Oy Asentajankatu 6 FI-00880 Helsinki, Finland Phone: +358 20 7795 500 Fax: +358 20 7795 396 Contact person: Lars Moring
UNITED STATES SALES REPRESENTATIVE (U.S. DESIGNATED AGENT)
Planmeca USA Inc. 100 North Gary Avenue, Suite A Roselle, IL 60172 Phone: (630) 529 2300 Fax: (630) 529 1929 Contact person : Bob Pienkowski
INTENDED USE
Planmeca Sovereign is a dental operative unit, which is an AC-powered device that is intended to supply power to and serve as a base for other dental devices and accessories. The device includes a dental patient chair, which is intended to properly position a patient to perform different dental procedures. The device is to be operated and used by dentists and other legally qualified professionals
PRODUCT DESCRIPTION
The Planmeca Sovereign is a dental operative unit including a dental patient chair. The design is very flexible with many motorized functions, and both left-handed and righthanded use is easily obtainable. The dentist and assistant are allowed to change their working postures according to the operation to be performed. The versatile swivelling enables fluent two-handed and four-handed treatment sequences. The unit is equipped with a digital control system with graphical user interface (GUI) to offer ease-of-use. The instrument console includes six instrument locations, with easy instrument interchange.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, clutching a caduceus. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 9 2008
Mr. Bob Pienkowski Managing Director Planmeca USA, Incorporated 100 North Gary Avenue, Suite A Roselle, Illinois 60172
Re: K081699
Trade/Device Names: Planmeca Sovereign Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: August 19, 2008 Received: August 22, 2008
Dear Mr. Pienkowski:
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.
2
Page 2 - Mr. Pienkowski
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 yours,
Thimuelis Lendmy for //
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
3
Indications for Use
510(k) Number (if known):
Device Name:
Planmeca Sovereign
Indications For Use:
Planmeca Sovereign is a dental operative unit, which is an ACpowered device that is intended to supply power to and serve as a base for other dental devices and accessories. The device includes a dental patient chair, which is intended to properly position a patient to perform different dental procedures. The device is to be operated and used by dentists and other legally qualified professionals.
Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
MSK
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number: K081699