(118 days)
The intended use of the Satelec Implant Center is to supply utilities to and serve as a base for dental tools and accessories for use by qualified dental practitioners.
The Satelec Implant Center is a dental operative unit that supplies utilities to and serves as a base for dental tools and accessories for use by qualified dental practitioners.
The provided text is a 510(k) summary for a dental operative unit. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way a medical AI/ML device submission would. This document is for a physical medical device.
Therefore, I cannot extract the requested information as it is not present in the provided text.
Here's why and what kind of information is present instead:
- Type of Device: The "Implant Center" is described as a "dental operative unit that supplies utilities to and serves as a base for dental tools and accessories." This is a hardware device, not an AI/ML algorithm.
- Approval Type: This is a 510(k) premarket notification, which establishes substantial equivalence to a predicate device. This is a common pathway for physical medical devices and typically focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving specific performance metrics through a clinical study with detailed acceptance criteria.
- "Study" Information: The document states that the "Satelec Implant Center is substantially equivalent to the predicate device by Satelec, the Cocoon Hygienist (K040529)." This "substantial equivalence" is the core of the evaluation, not a performance study against acceptance criteria.
- Missing Details: There is no mention of sensitivity, specificity, AUC, or any other performance metrics typically associated with AI/ML diagnostic or assistive devices. Likewise, no human reader studies, ground truth establishment, sample sizes for test/training sets, or expert qualifications are discussed because they are not relevant to this type of device submission.
In summary, the provided document describes a traditional medical device (dental operative unit) and its 510(k) clearance process based on substantial equivalence, not an AI/ML device with performance studies against acceptance criteria.
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8. Cleaning, Disinfecting, and Sterilization:
Unit casing can be decontaminated with dental disinfectant wipes.
Sterile tubing for irrigation is ethylene oxide (EO) sterilized and is for single use only.
Refer to specific user manuals for cleaning, disinfecting, and sterilizing the handpieces and cords used with the dental operative unit.
9. SMDA Summary of Safety and Effectiveness - "510(k) Summary"
A. Submitter Information SATELEC Z.I. du Phare, BP 30216 17, Avenue Gustave Eiffel 33708 Merignac Cedex FRANCE
Telephonê: 011 33 556 34 0607 Fax: 011 33 556 34 9292
Contact Person:
Steve Salesky SATELEC c/o Acteon, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 Telephone: 800 289-6367 Ext. 40 Fax: 856 222-4726 E-mail: steve.salesky@us.acteongroup.com
Date Prepared:
July 23, 2007
B. Device Identification
Common Usual Name: Dental operative unit and accessories
Proprietary Name: Implant Center
C. Identification of Predicate Device
| DeviceComments of Children of Children and Children | Applicant | 510(k) No.The property of the control of the control of the contributed | Date Cleared |
|---|---|---|---|
| Cocoon Hygienist | Satelec | K040529 | IAugust 19, 2004 |
The Satelec Implant Center is substantially equivalent to the predicate device by Satelec, the Cocoon Hygienist (K040529) previously cleared by the FDA and currently marketed.
NOV 1 9 2007
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D. Device Description
The Satelec Implant Center is a dental operative unit that supplies utilities to The Sutoloo implane for dental tools and accessories for use by qualified dental practitioners.
E. Substantial Equivalence
0
The Implant Center and the predicate device, Cocoon Hygienist (K040529) are both dental operative units that supply utilities to and serve as a base for dental both dental operative anile that supplif and practitioners. Differences that tools and accessories for access relating to technical specifications, performances and intended use are minor and do not affect the safety and effectiveness of the Implant Center.
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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health and Human Services, USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 2007
SATELEC C/O Mr. Steve Salesky Quality Manager ACTEON, Incorporated 124 Gaither Drive, Suite 140 Mount Laurel, New Jersey 08054
Re: K072030
Trade/Device Name: Implant Center Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZI Dated: November 12, 2007 Received: November 14, 2007
Dear Mr. Salesky:
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.
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Page 2 - Mr. Salesky
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Neil R.P. Ogden
Chiu Lin, Ph.D. d 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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Indications for Use
510(k) Number:
Device Name:
Implant Center
Indications for Use:
The intended use of the Satelec Implant Center is to supply utilities to and serve as a base for dental tools and accessories for use by qualified dental practitioners.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
5-1
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)
Suan Quare
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K072030
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.