(84 days)
Not Found
No
The 510(k) summary describes a dental operative unit that supplies utilities and serves as a base for tools, with no mention of AI, ML, image processing, or any data-driven analytical capabilities.
No
The device provides utilities and serves as a base for dental tools, but it does not directly treat or diagnose a disease or condition. Its function is supportive, not therapeutic.
No
The intended use explicitly states the device supplies utilities to and serves as a base for dental tools and accessories, rather than diagnosing a condition.
No
The device description clearly states it is a "dental operative unit that supplies utilities to and serves as a base for dental tools and accessories," indicating it is a hardware device.
Based on the provided information, the Satelec Implant Center 2 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for supplying utilities to and serving as a base for dental tools and accessories for use by qualified dental practitioners. This describes a device used in vivo (on a living patient) during dental procedures, not in vitro (outside the body) for examining specimens.
- Device Description: The description reinforces its role as a dental operative unit, supporting dental tools used directly on patients.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, tissue, etc.), performing tests on samples, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Satelec Implant Center 2 does not fit this description.
N/A
Intended Use / Indications for Use
"The intended use of the Satelec Implant Center 2 is to supply utilities to and serve as a base for dental tools and accessories for use by qualified dental practitioners."
Product codes (comma separated list FDA assigned to the subject device)
DZI
Device Description
The Satelec Implant Center 2 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.
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
qualified dental practitioners
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): 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
§ 872.4120 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.
0
SMDA Summary of Safety and Effectiveness - "510 (k) Summary" ത
JUL 2 2 2009
A. Submitter Information SATELEC 17, Avenue Gustave Eiffel BP 30216 33708 Merignac Cedex FRANČE
Telephone: 011 33 556 34 0607 Fax: 011 33 556 34 9292
Contact Person: Rick Rosati
SATELEC c/o ACTEON, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 Tel: 800 289-6367 Ext. 39 Fax: 856 222-4726 Email: rick.rosati@us.acteongroup.com
Date Prepared:
04 / 30 / 2009 REVISED 7/16/09
B. Device Identification
"Bone Cutting Instrument and Accessories" Common Usual Name:
Proprietary Name:
Implant Center 2
C. Identification of the Predicate Device
| Device | Applicant | 510(k) No. | Date Cleared |
|---|---|---|---|
| Implant Center | Satelec | K072030 | 11 / 19 / 2007 |
The Satelec Implant Center 2 is substantially equivalent to the predicate device by Satelec, the Implant Center (K072030) previously cleared by the FDA and currently marketed.
1
D. Device Description
The Satelec Implant Center 2 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.
E. Substantial Equivalence
The Implant Center 2 and the predicate device, Implant Center (K072030) are both dental operative units that supply utilities to and serve as a base for dental tools and accessories for use by qualified dental practitioners. Differences that exist between the devices relating to technical specification, performances and intended use are minor and do not affect the safety and effectiveness of the Implant Center 2.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 22 2000
SATELEC C/O Mr. Rick Rosati Quality Manager ACTEON, Incorporated 124 Gaither Drive, Suite 140 Mount Laurel, New Jersey 08054
Re: K091252
Trade/Device Name: IMPLANT CENTER 2 Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Material and Accessories Regulatory Class: II Product Code: DZI Dated: April 29, 2009 Received: April 29, 2009
Dear Mr. Rosati:
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 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.
3
Page 2- Mr. Rosati
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sion Cunner
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number:
Device Name:
IMPLANT CENTER 2
Indications for Use:
"The intended use of the Satelec Implant Center 2 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)
- 12 - 15 - 12 - 12 - 14
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)
Ken Muly for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091252