(49 days)
Not Found
No
The summary describes a system of dental implants, abutments, and surgical instruments, which are physical devices used in oral surgery. There is no mention of software, algorithms, or data processing that would indicate the presence of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No.
The device is described as bone-cutting instruments used during oral surgery to drill or cut into the upper or lower jaw. This description points to a surgical tool rather than a device designed to treat a disease or condition for therapeutic purposes.
No
The device, the Straumann P.004 Dental Implant System, is described as a system for supporting prosthetic devices and involves bone cutting instruments for oral surgery. Its intended use is for treatment (drilling or cutting bone to prepare for implants), not for diagnosing a condition or disease.
No
The device description explicitly states it consists of "a variety of dental implants, abutments and surgical and prosthetic parts and instruments," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical procedures (drilling or cutting bone) within the body (in vivo).
- Device Description: The device is a system of dental implants, abutments, and surgical/prosthetic parts and instruments, all used directly on the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose diseases or other conditions. This device is a surgical tool used directly on the patient's bone.
N/A
Intended Use / Indications for Use
Bone cutting instruments are intended for use during 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.
Product codes
DZI
Device Description
The Straumann P.004 Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw
Indicated Patient Age Range
Not Found
Intended User / Care Setting
oral surgery
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
OCT 2 1 2008
Section I 510(k) Summary
1. Applicant's Name and Address
Straumann US (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 800-448-8168, ext 2513 Fax Number: 978-747-0023 Contact Person: Elaine Alan Regulatory Affairs Specialist Date of Submission: August 29, 2008
2. Name of the Device
| Trade Name: | Straumann Guided Instruments |
|---|---|
| Common Name: | Drill Bits |
| Classification Name: | Bone Cutting Instrument and Accessories |
| Regulation Number: | §872.4120 |
3. Legally Marketed Device to which Equivalence is Claimed (Predicate Device)
Bone Cutting Instruments, K894844
4. Description of the Device
The Straumann P.004 Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.
5. intended Use of the Device
Bone cutting instruments are intended for use during 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.
6. Technological Characteristics
The proposed Straumann Guided Instruments are substantially equivalent to the currently marketed devices. The intended use is identical to the predicate devices. The proposed drill bits have the same material composition, basic design and fundamental operating principles to the currently marketed devices.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 2008
Ms. Elaine Alan Regulatory Affairs Specialist Straumann USA 60 Minuteman Road Andover, Massachusetts 01810
Re: K082532
Trade/Device Name: Straumann Guided Instruments Regulation Number: 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZI Dated: August 29, 2008 Received: September 2, 2008
Dear Ms. Alan:
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 - Ms. Alan
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,
J.N. Samuels-Lendry frey
Chiu S. Lin, Ph. D Division 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 Statement
Device Name: Straumann Guided Instruments
Indications for Use:
Bone cutting instruments are intended for use during 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.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Susan Runner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081532
510(k) Submission: Straumann Guided Instruments August 29, 2008 Proprietary and Confidential
Straumann US Page 5