(111 days)
Not Found
No
The document describes a physical dental implant and its surgical placement and function. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended to restore patient esthetics and chewing function, which are therapeutic benefits.
No
Explanation: This device is a dental implant intended to provide support for prosthetic devices to restore patient esthetics and chewing function. It is a treatment device, not a diagnostic one, as it does not diagnose a condition.
No
The device description clearly states that the device is a threaded, root-form dental implant, which is a physical hardware component.
Based on the provided text, 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.
- Device description and intended use: The text clearly describes the NOBELSPEEDY™ Implants as surgically placed devices intended to support prosthetic devices in the jawbone. This is a physical implant used in vivo (within the body), not a test performed in vitro (outside the body).
The device is a medical device, specifically a dental implant, but it does not fit the definition of an IVD.
N/A
Intended Use / Indications for Use
NOBELSPEEDY™ Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NOBELSPEEDY™ Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare NOBELSPEEDY™ Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.
NOBELSPEEDY™ Implants are indicated for use in soft bone or whenever immediate or early loading is applied. The NOBELSPEEDY™ Implants incorporate a groove on the implant thread and are preferred over models without the groove in these soft bone indications because bone forms more rapidly in the groove than on other parts of the implant resulting in increased stability when compared to non-grooved implants. In addition, the NOBELSPEEDY™ Implants are preferred in these soft bone indications because bone formation on the TiUnite® surface is more rapid and greater than on machined surface implants resulting in better maintenance of initial implant stability, faster and stronger osseointegration, and higher success rates.
NOBELSPEEDY™ Implants may be tilted up to 45°. When used with angulations between 30° and 45° a minimum of four implants must be used and splinted.
Product codes
DZE
Device Description
Nobel Biocare's NOBELSPEEDY" Implants are threaded, root-form dental implants intended for use in the upper and lower jaw to support prosthetic devices, such as artificial teeth, in order to restore esthetics and chewing function to partially or fully edentulous patients.
NOBELSPEEDY" Implants incorporate a groove on the threads of the implant and have a tapered apex. NODELOT LED I " implants interperate a yallable with a straight contour. NOBELSPEEDY" Implants have a surface treatment consisting of a titanium oxide layer, (TiUnite®), which extends from the implant threads onto the implant collar.
Nobel Biocare's NOBELSPEEDY" Implants may be placed in the oral cavity using either a single stage surgical procedure or a two stage surgical procedure. If a single stage procedure is used, the implants Surgical procedure of a two clayour post post initial stability of the implant can be obtained. NOBELSPEEDY™ Implants can be placed in soft bone and under-prepared sites.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
upper or lower jaw 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
2005 Kc
Kosoyob
510(k) Summary of Safety and Effectiveness 1.4
| Submitted by: | Elizabeth J. Mason
Sr. Regulatory Affairs Specialist |
|----------------------------------------|----------------------------------------------------------------------------|
| Address: | Nobel Biocare USA LLC
22715 Savi Ranch Parkway
Yorba Linda, CA 92887 |
| Telephone: | (714) 282-4800, ext. 7830 |
| Facsimile: | (714) 282-9023 |
| Date of Submission: | February 16, 2005 |
| Classification Name: | Endosseous Implant (21 CFR 872.3640) |
| Trade or Proprietary
or Model Name: | NOBELSPEEDY™ Implants |
| Legally Marketed Device(s): | Nobel Biocare Endosseous Implants (K041661) |
Device Description:
Nobel Biocare's NOBELSPEEDY" Implants are threaded, root-form dental implants intended for use in the upper and lower jaw to support prosthetic devices, such as artificial teeth, in order to restore esthetics and chewing function to partially or fully edentulous patients.
NOBELSPEEDY" Implants incorporate a groove on the threads of the implant and have a tapered apex. NODELOT LED I " implants interperate a yallable with a straight contour. NOBELSPEEDY" Implants have a surface treatment consisting of a titanium oxide layer, (TiUnite®), which extends from the implant threads onto the implant collar.
Nobel Biocare's NOBELSPEEDY" Implants may be placed in the oral cavity using either a single stage surgical procedure or a two stage surgical procedure. If a single stage procedure is used, the implants Surgical procedure of a two clayour post post initial stability of the implant can be obtained. NOBELSPEEDY™ Implants can be placed in soft bone and under-prepared sites.
Indications for Use:
managene form indosseous implants intended to be surgically placed in the NODELST LED I - Implants and root for rovide support for prosthetic devices, such as an artificial tooth, bone of the upper of tont rathetics and chewing function. Nobel Biocare's NOBELSPEEDY" Implants in order to restore patient obtitled ant restorations in splinted or non-splinted applications. are indicated for birgio of manay be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.
NOBELSPEEDY™ Implants are indicated for use in soft bone or whenever immediate or early loading is applied. The NOBELSPEEDY" Implants incorporate a groove on the implant thread and are preferred applied. The NODELST EED - Implants in&olders because bone forms more rapidly in the over models without the groot in those ook ill increased stability when compared to non-grooved implants. In addition, the NOBELSPEED'" Implants are preferred in these soft bone indications because miplants. In addition, the Nee surface is more rapid and greater than on machined surface implants bone formation on the Tronice - Gardoo is more rapid an faster and stronger osseointegration, and higher success rates.
NOBELSPEEDY™ Implants may be tilted up to 45°. When used with angulations between 30° and 45° a minimum of four implants must be used and splinted.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a seal for the Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread. The eagle is facing to the right and has three lines representing its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 8 - 2005
Nobel Biocare USA LLC C/O Mr. Herbert Crane Regulatory Affairs Director Nobel Bicoare US, Incorporated 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K050406
Trade/Device Name: NOBELSPEEDYTM Implants Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: May 27, 2005 Received: May 31, 2005
Dear Mr. Crane:
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.
2
Page 2 - Mr. Crane
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 vours,
Jenite Y. Micklin MD.
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
3
510(k) Number (if known): Koso 40 G
Device Name: NOBELSPEEDY™ Implants
Indications For Use:
1.3
NOBELSPEEDY™ Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NOBELSPEEDY™ Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare NOBELSPEEDY™ Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.
NOBELSPEEDY™ Implants are indicated for use in soft bone or whenever immediate or early loading is applied. The NOBELSPEEDY™ Implants incorporate a groove on the implant thread and are preferred over models without the groove in these soft bone indications because bone forms more rapidly in the groove than on other parts of the implant resulting in increased stability when compared to non-grooved implants. In addition, the NOBELSPEEDY™ Implants are preferred in these soft bone indications because bone formation on the TiUnite® surface is more rapid and greater than on machined surface implants resulting in better maintenance of initial implant stability, faster and stronger osseointegration, and higher success rates.
NOBELSPEEDY™ Implants may be tilted up to 45°. When used with angulations between 30° and 45° a minimum of four implants must be used and splinted.
× 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)
Susan Runyon
(Division Sign-C Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
Page 1 of 1
510(k) Number: