(82 days)
Not Found
No
The summary describes a dental implant, a physical device, and makes no mention of software, algorithms, or any technology related to AI or ML.
No
The device is a dental implant intended to support prosthetic devices to restore esthetics and chewing function, which is a restorative rather than a therapeutic function.
No
The device, NobelPerfect Conical Connection implants, is a dental implant designed to provide support for prosthetic devices to restore patient aesthetics and chewing function. It is a therapeutic device, not a diagnostic one, as it does not identify or analyze a condition.
No
The device description clearly states it is a threaded, root-form dental implant machined from commercially pure titanium, which is a physical hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is an endosseous dental implant intended for surgical placement in the bone to support prosthetic devices. This is a surgical and restorative function, not a diagnostic one performed on samples outside the body.
- Device Description: The description details the physical characteristics of the implant (material, design, surface treatment) and its purpose in supporting prosthetics. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD characteristics: The text does not mention any of the typical features of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, the Nobel Biocare's NobelPerfect Conical Connection implants are a medical device used for surgical implantation and prosthetic support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Nobel Biocare's NobelPerfect Conical Connection implants are endosseous dental 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 NobelPerfect Conical Connection implants are indicated for single or multiple unit restorations. The NobelPerfect Conical Connection implants can be used in splinted or non-splinted applications. The NobelPerfect Tapered Conical Connection implant 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)
DZE, NHA
Device Description
Nobel Biocare's NobelPerfect Conical Connection implants are threaded, root-form dental implants intered 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 NobelPerfect Conical Connection implants are similar in design to the NobelPerfect Groovy implants cleared under "Groovy Implants" (K050258). Like the NobelPerfect Groovy implant, the NobelPerfect Conical Connection implant is machined from commercially pure titanium, grade 4, have a tapered body Onlival Onlinedian implant is machines nother the body, and a TiUnite "sufface treatment. The difference between the two implants is that the NobelPerfect Conical Connection implants have the same internal conical connection as the SFB implants, cleared under "SFB & CFB Implants"(K061003).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
bone of the upper or lower jaw arches
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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 of Safety and Effectiveness 1.4
| DEC 19 2006 | |||
|---|---|---|---|
| Submitted by: | Ms. Phuong Nguyen Son | ||
| 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: | September 27, 2006 | ||
| Classification Name: | Endosseous Dental Implant (21 CFR 872.3640) | ||
| Trade or Proprietary | |||
| or Model Name: | NobelPerfect Conical Connection | ||
| Legally Marketed Device(s): | Groovy Implants (K050258) | ||
| SER & CER Implants (K061003) |
Device Description:
Nobel Biocare's NobelPerfect Conical Connection implants are threaded, root-form dental implants intered 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 NobelPerfect Conical Connection implants are similar in design to the NobelPerfect Groovy implants cleared under "Groovy Implants" (K050258). Like the NobelPerfect Groovy implant, the NobelPerfect Conical Connection implant is machined from commercially pure titanium, grade 4, have a tapered body Onlival Onlinedian implant is machines nother the body, and a TiUnite "sufface treatment. The difference between the two implants is that the NobelPerfect Conical Connection implants have the same internal conical connection as the SFB implants, cleared under "SFB & CFB Implants"(K061003).
Indications for Use:
Nobel Biocare's NobelPerfect Conical Connection implants are endosseous dental 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 NobelPerfect Conical Connection implants are indicated for single or multiple unit restorations. The NobelPerfect Conical Connection implants can be used in splinted or non-splinted applications. The NobelPerfect Tapered Conical Connection implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the bird figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nobel Biocare AB C/O Ms. Phuong Nguyen Son Regulatory Affairs Specialist Nobel Biocare USA, LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887
DEC 1 9 2006
Re: K062936
Trade/Device Name: NobelPerfect Conical Connection Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: November 29, 2006 Received: November 30, 2006
Dear Ms. Son:
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. Son
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 yours.
Clive
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
Indications for Use
510(k) Number (if known): KO 6 2936
Device Name: NobelPerfect Conical Connection
Indications For Use:
Nobel Biocare's NobelPerfect Conical Connection implants are endosseous dental 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 NobelPerfect Conical Connection implants are indicated for single or multiple unit restorations. The NobelPerfect Conical Connection implants can be used in splinted or nonsplinted applications. The NobelPerfect Conical Connection implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.
× 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)
Sesam Punne
Anesthesiology, General Hospital,
Pain Control, Dental Devices
4-06-298.
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