(153 days)
Not Found
No
The summary describes a dental implant and related components, focusing on materials, dimensions, and intended use. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The device is an endosseous implant intended to restore patient esthetics and chewing function, which are therapeutic benefits.
No
The device description indicates that NobelActive implants are endosseous implants intended to be surgically placed in the bone to support prosthetic devices, not to diagnose a condition.
No
The device description clearly states it is a threaded, root-form dental implant made of commercial pure titanium, which is a physical 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 medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description and Intended Use: The description clearly states that the NobelActive implants are surgically placed in the bone to support prosthetic devices. This is an in vivo application (within the living body), not an in vitro application (outside the living body).
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, diagnostic testing, or monitoring of physiological processes through laboratory methods.
Therefore, the Nobel Biocare NobelActive implants are a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Nobel Biocare's NobelActive 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. Nobel Biocare's NobelActive implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's NobelActive implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Product codes
DZE, NHA
Device Description
Nobel Biocare's NobelActive Wide Platform (WP) implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients. They are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The NobelActive Wide Platform (WP) implants share the same basic design principles as the existing NobelActive Internal Connection Implant. The Wide Platform (WP) implants are a bigger diameter implant extending the range of the existing NobelActive platforms. The Wide Platform is made of commercial pure titanium, is 5.5 mm in diameter, and available in lengths from 6.5 mm to 12.5 mm.
Healing and temporary abutments in both titanium/vanadium alloy and PEEK and definitive abutments made of titanium/vanadium alloy are available for the new WP platform. Titanium abutments may also be designed and made individually to fit the individual requirements for each patient using NobelBiocare's NobelProcera system.
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
Nobel Biocare utilizes an ISO 14971 Risk Management System. The NobelActive Wide Platform (WP) was subjected to this system which determined that no clinical test data was necessary to support the decision of safety and effectiveness excluding the MRI Safety and compatibility. MR conditional testing was conducted according to FDA Guidance Document "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment".
Key Metrics
Not Found
Predicate Device(s)
K071370, K083205, K050406, K120954, K091756
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
MAY 0 8 2014
510(k) Summary A.4.
| Submitted by: | Phuong Nguyen
Senior Regulatory Affairs Manager
Nobel Biocare USA LLC
22715 Savi Ranch Parkway
Yorba Linda, CA 92887 |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted for: | Nobel Biocare AB
Vastra Hamngatan 1
Goteborg, SE 411 17
Sweden |
| Telephone: | (714) 282-4800 x7830 |
| Facsimile: | (714) 998-9348 |
| Date of Submission: | December 5, 2013 |
| Classification Name:
Product Code: | Endosseous Dental Implant (21 CFR 872.3640)
DZE, NHA |
| Trade or Proprietary
or Model Name: | NobelActive Wide Platform (WP) |
| Legally Marketed Devices: | Nobel Biocare - NobelActive Internal Connection Implant (K071370)
Nobel Biocare - NobelProcera PEEK Abutments (K120954)
Nobel Biocare - NobelProcera Ti Abutments (K091756)
Nobel Biocare - NobelSpeedy Implants (K050406)
Nobel Biocare - NobelActive 8.5 mm & 18.0 mm (K083205) |
Device Description:
Nobel Biocare's NobelActive Wide Platform (WP) implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients. They are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The NobelActive Wide Platform (WP) implants share the same basic design principles as the existing NobelActive Internal Connection Implant. The Wide Platform (WP) implants are a bigger diameter implant extending the range of the existing NobelActive platforms. The Wide Platform is made of commercial pure titanium, is 5.5 mm in diameter, and available in lengths from 6.5 mm to 12.5 mm.
Healing and temporary abutments in both titanium/vanadium alloy and PEEK and definitive abutments made of titanium/vanadium alloy are available for the new WP platform. Titanium abutments may also be designed and made individually to fit the individual requirements for each patient using NobelBiocare's NobelProcera system.
Indications for Use:
Nobel Biocare's NobelActive 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. Nobel Biocare's
1
NobelActive implants are indicated for single or multiple unit restorations in splinted or nonsplinted applications. Nobel Biocare's NobelActive implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Summary of testing to demonstrate Substantial Equivalence
Nobel Biocare utilizes an ISO 14971 Risk Management System. The NobelActive Wide Platform (WP) was subjected to this system which determined that no clinical test data was necessary to support the decision of safety and effectiveness excluding the MRI Safety and compatibility. MR conditional testing was conducted according to FDA Guidance Document "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment".
Modifications were made to the NobelActive product labeling to include the Wide Platform.
Conclusion
The information provided in this submission demonstrates that the device is substantially equivalent to the predicate devices.
2
Technological Characteristics
. ^
| CANDIDATE | PREDICATE | PREDICATE | PREDICATE | |
|---|---|---|---|---|
| NobelActive Wide Platform (WP) | NobelActive Internal Connection Implant (K071370) | NobelActive 8.5 mm & 18.0 mm (K083205) | NobelSpeedy Implants (K050406) | |
| Thread Design | Double lead thread | |||
| Reverse cutting flutes | Double lead thread | |||
| Reverse cutting flutes | Double lead thread | |||
| Reverse cutting flutes | Single lead thread | |||
| Implant Body Design | Expanding Taper | |||
| Drilling blades on apex | Expanding Taper | |||
| Drilling blades on apex | Expanding Taper | |||
| Drilling blades on apex | Tapered apex with bone cutting flutes | |||
| Implant Body Length | 6.5, 8, 9.5, 11, 12.5 mm | 9.5, 11, 12.5 mm | 8, 17.5 mm | 6.5, 8, 9.5, 11, 12.5, 14.5, 17.5 mm |
| Overall Length | 6.5, 8, 9.5, 11, 12.5 mm | 9.5, 11, 12.5 mm | 8, 17.5 mm | 7, 8.5, 10, 11.5, 13, 15, 18 mm |
| Implant Width | 5.5 mm | 3.5, 4.3, 5 mm | 3.5, 4.3, 5 mm | 3.5, 4.0, 5.0, 6.0 mm |
| Connection Type | Internal Hex | Internal Hex | Internal Hex | External Hex |
| Device Material | CP Titanium | CP Titanium | CP Titanium | CP Titanium |
| Surface | TiUnite | TiUnite | TiUnite | TiUnite |
| Labeling | MR Safety Information | |||
| Section Implant specification additional warning related to short Implants | No MR Safety information | |||
| No additional warnings regarding short implants | No MR Safety information | |||
| No additional warnings regarding short implants | No MR Safety information | |||
| No additional warnings regarding short implants |
3
echnological Characteristics
(Part 2 — Abutments)
| | CANDIDATE
NobelActive Wide
Platform (WP) | PREDICATE
NobelActive Internal
Connection Implant (K07-1370) | PREDICATE
NobelProcera PEEK Abutments
(K120954) | PREDICATE
NobelProcera Ti Abutments
(K091756) |
|---------------|-----------------------------------------------------|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Material | Titanium/vanadium alloy
PEEK | Titanium/vanadium alloy | PEEK | Titanium/vanadium alloy |
| Intended Use | Definitive restorations
Provisional restorations | Definitive restorations
Provisional restorations | Provisional restorations | Definitive restorations |
| Design Method | Standardized design
Patient specific design | Standardized design | Standardized design
Patient specific design | Patient specific design |
| Platform | Internal Hex 5.5 mm | Internal Hex 3.5, 4.3, 5 mm | Internal Hex 3.5, 4.3, 5 mm
External Hex 3.5, 4, 5 mm
Internal Tri-Lobe 3.5, 4.3, 5, 6 mm | Internal Hex 3.5, 4.3, 5 mm
External Hex 3.5, 4, 5 mm
Internal Tri-Lobe 3.5, 4.3, 5, 6 mm
Various third party platforms |
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 8, 2014
Nobel Biocare AB C/O Ms. Phuong Nguyen Senior Regulatory Affairs Manager Nobel Biocare USA, Limited Liability Company 22715 Savi Ranch Parkway Yorba Linda, CA 92887
Re: K133731
Trade/Device Name: NobelActive Wide Platform (WP) Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: March 5, 2014 Received: March 7, 2014
Dear Ms. Nguyen:
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 for ass stated in the energency77, the enactment date of the Medical Device Amendments, or 10 conninered prior to may 20, 1770) the 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 The general controls provisions and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
ff your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it If your device is elassified (see above). 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.
5
Page 2 - Ms. Nguyen
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K133731
Device Name: NobelActive Wide Platform (WP)
Indications For Use:
Nobel Biocare's NobelActive 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. Nobel Biocare's NobelActive implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's NobelActive implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
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)
Sheena A. Gr 2014.05.08 07:4
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