(66 days)
Not Found
No
The 510(k) summary describes a physical implant made of titanium with a specific design and surface treatment. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes.
The device facilitates the orthodontic movement of teeth, which is a therapeutic treatment.
No
Explanation: The device is an endosseous implant used as an anchorage point for orthodontic appliances, not for diagnosing medical conditions.
No
The device description clearly states it is a physical implant made from titanium, which is a hardware component.
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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this device is an "endosseous implant" intended for placement within the body (specifically, the hard palate or retromolar positions). Its purpose is to provide a physical anchorage point for orthodontic appliances.
- No Mention of Samples or Testing: There is no mention of this device being used to analyze samples from the body or perform any kind of diagnostic test.
This device is a medical device, specifically an implantable device used for orthodontic treatment. It is not an IVD.
N/A
Intended Use / Indications for Use
The Ortho implant of the Straumann Ortho system is an endosseous implant intended for placement in the mid-sagittal area of the hard palate or in retromolar positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed after orthodontic treatment has been completed.
The Ortho implant of the Straumann Ortho system is an endosseous implant intended for placement in the mid-sagittal or paramedian area of the hard palate or in retromolar positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed after orthodontic treatment has been completed.
Product codes
OAT
Device Description
The Ortho implant is a solid, one-piece, threaded, self-tapping design made from CP Grade 4 titanium. It has a sand-blasted, acid etched (SLA) rough surface on the endossous portion of the implant. The transmucosal section of the implant has a smooth machined surface to allow for the attachment of epithelial tissue. The coronal portion of the implant is internally threaded and has a hex head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mid-sagittal area of the hard palate or in retromolar positions, mid-sagittal or paramedian area of the hard palate or in retromolar positions
Indicated Patient Age Range
adults and juveniles (age 12 and older). In case of patients who have not yet completed skeletal growth (e.g. as shown by radiographic analysis of the hand/wrist), the ortho implant should be placed off the mid-line in the paramedian region of the palate in order to avoid the midpalatal suture.
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)
Reference Device(s)
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
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
K04 0469
ATTACHMENT 8
510(k) Summary
Applicant's Name and Address 1 .
Straumann USA (on behalf of Institut Straumann AG) Reservoir Place 1601 Trapelo Road Waltham, MA 024511 Telephone Number: 781-890-000 1 Fax Number: 781-890-6464 Contact Person: Carolyn Bitetti Associate Director, Regulatory Affairs
2. Name of the Device
Trade Name: Common Name: Classification Name: Straumann Ortho implant Endosseous dental implants Endosseous dental implants 21 CFR 872.3640
3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices)
Straumann Ortho System (K982509)
র্ব . Description of the Device
The Ortho implant is a solid, one-piece, threaded, self-tapping design made from CP Grade 4 titanium. It has a sand-blasted, acid etched (SLA) rough surface on the endossous portion of the implant. The transmucosal section of the implant has a smooth machined surface to allow for the attachment of epithelial tissue. The coronal portion of the implant is internally threaded and has a hex head.
- Indications for Use 5.
CONFIDENTIAL 510(k) Straumann Ortho Implant Page 33 February 17, 2004
1
The Ortho implant of the Straumann Ortho system is an endosseous implant intended for placement in the mid-sagittal area of the hard palate or in retromolar positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed after orthodontic treatment has been completed.
Basis for Substantial Equivalence 6.
The subject Ortho implants are substantially equivalent in intended use to the currently marketed Straumann Ortho implants.
The subject Straumann Ortho implants have the same design as the previously cleared Straumann Ortho implants. There has been no change in material, surface treatment, design, or operating principle.
CONFIDENTIAL 510(k) Straumann Ortho Implant Page 34 February 17, 2004
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 2 2007
Ms. Carolyn Bitetti Associate Director, Regulatory Affairs The Straumann Company Reservoir Place 1601 Trapelo Road Waltham, Massachusetts 02451
Re: K040469
Trade/Device Name: The Straumann Ortho Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: OAT Dated: February 20, 2004 Received: February 24, 2004
Dear Ms. Bitetti:
This letter corrects our substantially equivalent letter of April 30, 2004.
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 (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 - Ms. Bitetti
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 continue 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-__(see http://www.fda.gov/cdrh/organiz.html#OC for OC organization structure). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sutte y. Mchier Cus
Chiu S. Lin. PhD 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
K040469 510(k) Number (K982509):
Device Name: Straumann Ortho Implant
Indications for Use:
The Ortho implant of the Straumann Ortho system is an endosseous implant intended for placement in the mid-sagittal or paramedian area of the hard palate or in retromolar positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed after orthodontic treatment has been completed.
Ortho implants can be used in adults and juveniles (age 12 and older). In case of patients who have not yet completed skeletal growth (e.g. as shown by radiographic analysis of the hand/wrist), the ortho implant should be placed off the mid-line in the paramedian region of the palate in order to avoid the midpalatal suture.
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)
Robert Betz, DNSL, & Susan Runner
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
CONFIDENTIAL 510(k) Straumann Ortho Implang10(k) Number:
510(k) Straumann Ortho Implang10(k) Number:
Bago 38 Page 38 February 17, 2004
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