(65 days)
Not Found
No
The 510(k) summary describes a standard dental implant and does not mention any AI or ML components or functionalities.
No
The device provides support for prosthetic devices to restore function and esthetics, which are considered restorative rather than therapeutic.
No
The device is an endosseous implant designed to support prosthetic devices, not to diagnose medical conditions. Its purpose is to restore esthetics and chewing function, not to identify or monitor diseases.
No
The device description clearly states it is a threaded, root-form dental implant, which is a physical hardware device.
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.
- Device Description: The description clearly states that the NobelReplace Hexagonal Implants are "endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches." This describes a surgically implanted medical device, not a test performed on a sample outside the body.
- Intended Use: The intended use is to "provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function." This is a functional restoration, not a diagnostic test.
Therefore, the NobelReplace Hexagonal Implants are a medical device, specifically a dental implant, and not an IVD.
N/A
Intended Use / Indications for Use
Nobel Biocare's NobelReplace Hexagonal Implants are 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. The NobelReplace Hexagonal Implants are indicated for single or multiple unit restorations. The NobelReplace Hexagonal Implants can be used in splinted or non-splinted applications. The NobelReplace Hexagonal Implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.
Product codes (comma separated list FDA assigned to the subject device)
NZE
Device Description
NobelReplace Hexagonal Implants are threaded, root-form dental implants intended for use in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients.
The NobelReplace Hexagonal Implants are similar in design to the implants cleared under NobelReplace Tapered Conical Connection, K062566. The predicate internal square was changed to internal bexagonal connection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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): 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
§ 872.3640 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
KO-73142
1.4 510(k) Summary of Safety and Effectiveness
| Submitted by: | Kam Leung, Ph.D., RAC
Senior Regulatory Affairs Specialist | |
|----------------------------------------|----------------------------------------------------------------------------|-------------|
| Address: | Nobel Biocare USA LLC
22715 Savi Ranch Parkway
Yorba Linda, CA 92887 | |
| Telephone: | (714) 282-4800, ext. 7842 | JAN 11 2008 |
| Facsimile: | (714) 282-9023 | |
| Date of Submission: | November 6, 2007 | |
| Classification Name: | Endosseous dental implant (21CFR872.3640) | |
| Trade or Proprietary
or Model Name: | NobelReplace Hexagonal Implant | |
Legally Marketed Device(s): NobelReplace Tapered Conical Connection (K062566)
Device Description:
NobelReplace Hexagonal Implants are threaded, root-form dental implants intended for use in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients.
The NobelReplace Hexagonal Implants are similar in design to the implants cleared under NobelReplace Tapered Conical Connection, K062566. The predicate internal square was changed to internal bexagonal connection.
Indications for Use:
Nobel Biocare's NobelReplace Hexagonal Implants are 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. The NobelReplace Hexagonal Implants are indicated for single or multiple unit restorations. The NobelReplace Hexagonal Imvlagonal be used in splinted or non-splinted applications. The NobelReplace Hexagonal Implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with healthcare, consisting of a staff with two snakes entwined around it. The seal is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.
JAN 11 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nobel Biocare AB C/O Kam Leung, Ph.D., RAC Senior Regulatory Affairs Specialist Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K073142
Trade/Device Name: NobelReplace Hexagonal Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: DZE Product Code: II Dated: January 7, 2008 Received: January 8, 2008
Dear Dr. Leung:
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 - Dr. Leung
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.
Snyte y. Michie Omd.
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
1.3 Indication for Use
510(k) Number (if known):
Device Name: NobelReplace Hexagonal Implants
Indication For Use:
Nobel Biocare's NobelReplace Hexagonal Implants are 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. The NobelReplace Hexagonal Implants are indicated for single or multiple unit restorations. The NobelReplace Hexagonal Implants can be used in splinted or non-splinted applications. The NobelReplace Hexagonal Implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.
(Division Sign-Off) Susen Runno
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
Prescription Use
(21 CFR Part 801 Subpart D)
Over the Counter Use (21 CFR Part 801 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)