(106 days)
No
The 510(k) summary describes a dental implant, a physical device, and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The description focuses on the physical characteristics and intended use of the implant itself.
Yes
The device is described as "supporting prosthetic restorations" and helping to "restore chewing function," which indicates it is used to treat or alleviate a condition (tooth loss) and improve function, fitting the definition of a therapeutic device.
No
The device description and intended use indicate that the Straumann Dental Implant is an implantable device used to support prosthetic restorations for chewing function, not to diagnose a condition.
No
The device description clearly states it is a "Straumann Dental Implant," which is a physical, surgically implanted device made of material composition and having a specific design and surface treatment. It is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use clearly state that this device is a dental implant intended for surgical placement in the jawbone to support prosthetic restorations. It is a physical implant used in the body, not a device used to test samples from the body.
The text focuses on the surgical placement, function, and design of the implant itself, which are characteristics of a medical device used for treatment or restoration, not for diagnostic testing.
N/A
Intended Use / Indications for Use
Straumann Regular Neck and Narrow Neck implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used.
The Straumann Regular Neck Implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients for single-stage or two-stage surgery.
The Straumann Narrow Neck implants are intended for surgical placement in the maxilla or mandible to serve as a base for prosthetic reconstructions. Specifically, the Narrow Neck implant is indicated for replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. It is particularly intended for those areas where the interdental space is extremely limited (minimum 5 mm) and where vestibule-oral bone is restricted (minimum 5 mm). The Narrow Neck implant can also be used as a support for a full arch implant-born restoration, but only in conjunction with a standard Straumann 4. 1 mm dental implant.
Product codes
DZE
Device Description
The Straumann Dental Implant with anodized neck is a minor modification of cleared Straumann Dental Implants. The implants with anodized neck are available in two neck sizes, RN diameter 4.8 mm and NN diameter 3.5 mm. The design of the modified implants is identical to the predicate implants. There is no change to the endosseous grit blasted, acid etched SLA surface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and/or mandibular arches
Indicated Patient Age Range
Not Found
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
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
510(k) Summary
1. Applicant's Name and Address
Straumann USA (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 800-448-8168, ext 2513 Fax Number: 978-747-0031 Contact Person: Elaine Alan Regulatory Affairs
2. Name of the Device
| Trade Name: | Straumann Dental Implants |
|---|---|
| Common Name: | Dental Implants |
| Classification Name: | Endosseous dental implants |
| 21 CFR 872.3640 |
3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices)
Straumann RN Dental Implants, originally cleared under K033922 and K030007 Straumann NN Implants, originally cleared under K010291 and K030007
4. Description of the Device
The Straumann Dental Implant with anodized neck is a minor modification of cleared Straumann Dental Implants. The implants with anodized neck are available in two neck sizes, RN diameter 4.8 mm and NN diameter 3.5 mm. The design of the modified implants is identical to the predicate implants. There is no change to the endosseous grit blasted, acid etched SLA surface.
5. Intended Use of the Device
There is no change to the intended use associated with the modification. The neck portion is anodized for esthetic purposes.
6. Basis for Substantial Equivalence
The subject implants are substantially equivalent to the previously cleared Straumann implants cleared in, K033922, K030007 and K010291. The intended use is identical to the predicate devices. The subject implants with anodized neck are intended for placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations.
1
The subject implants have the same material composition and the same endosseous surface treatment as previously cleared Straumann implants. In addition, the design of the implant is identical to the predicate devices.
:
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 1 2006
Institut Straumann AG C/O Ms. Elaine Alan Regulatory Affairs Specialist Straumann USA 60 Minuteman Road Andover, Massachusetts 01810
Re: K061176
Trade/Device Name: Straumann Anodized Neck Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: July 13, 2006 Received: July 14, 2006
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.
3
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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Syber Rurr
Chin Lin, Ph.D.
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
4
Indications for Use Statement
510(k) Number (if known): K061176
Device Name: Straumann Anodized Neck Implants
Indications for Use:
Straumann Regular Neck and Narrow Neck implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used.
The Straumann Regular Neck Implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients for single-stage or two-stage surgery.
The Straumann Narrow Neck implants are intended for surgical placement in the maxilla or mandible to serve as a base for prosthetic reconstructions. Specifically, the Narrow Neck implant is indicated for replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. It is particularly intended for those areas where the interdental space is extremely limited (minimum 5 mm) and where vestibule-oral bone is restricted (minimum 5 mm). The Narrow Neck implant can also be used as a support for a full arch implant-born restoration, but only in conjunction with a standard Straumann 4. 1 mm dental implant.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Page 1 of 1 |
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| Request for additional Information K061176 |
| July 13, 2006 |
| Sign-Off | |
|---|---|
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices Confidential |
| Number: | K061176 |
|---|---|
| Page 4 of 9 |