(294 days)
No
The summary describes a physical dental implant and its components. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
Yes
The device is described as a permanent anchorage for prosthetic devices that restores chewing function and aesthetic appearance, which are therapeutic goals.
No
Explanation: The device is a dental implant designed to restore chewing function and aesthetic appearance. Its intended use and device description focus on surgical placement and physical restoration, not on diagnosing medical conditions.
No
The device description clearly describes a physical, threaded, root-form titanium dental implant, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical procedure to place a dental implant in the bone of the jaw to restore chewing function and aesthetics. This is a surgical device used directly on the patient's body.
- Device Description: The description details a physical implant made of titanium, designed for surgical placement and connection to prosthetic devices. It does not mention any components or processes related to testing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a physical implant for surgical and prosthetic restoration.
N/A
Intended Use / Indications for Use
The Neoss Tapered Implant is for single-stage or two-stage surgical procedure and cement or screw retained restorations.
The Neoss Tapered Implant is intended for immediate placement and function on single tooth and /or multiple tooth applications recognizing sufficient bone stability and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The Neoss Tapered Implant is a threaded, internal abutment connection, root-form titanium dental implant. The Neoss Tapered Implant consists of a number of implants with a diameter of Ø3.5 to Ø5.5 mm and lengths between 7.0 – 17.0 mm; all sizes have the same internal abutment connection dimension independent of implant diameter.
The internal connection is equipped with interlocking elements for an insertion tool and the non-rotational locking of the abutment. The Neoss ProActive Tapered Implant System is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices, which can restore chewing function and aesthetic appearance. Supplied sterile.
The Neoss Implant System has specific design characteristics for mating Neoss components such as implants, abutments and prosthetic components. Combining components that are not configured or dimensioned for correct mating can lead to mechanical failure of components, damage to tissue, or unsatisfactory esthetic results. Abutment screws made in gold alloy, titanium or Ti with TiN/Au are available. Screw driver connection is compatible with screwdrivers supplied by Neoss. The abutment screws are supplied non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper /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)
Performed fatigue tests of ProActive implants (K083561) shows results well in line with requirements. Clinical feedback and only one fracture related complaint confirms that the implant strength is adequate. The design in critical areas shows enough similarity between the two implant types to conclude that Neoss Tapered Implants will show equivalent results as for ProActive Implants in a fatigue test.
The Neoss Tapered Implant has an enhanced primary stability, i.e. mechanical stability at time of insertion as measured by in vitro insertion, displacement, and theoretical implantbone contact analysis, compared to a straight Neoss implant. This testing of primary stability and long term clinical outcome has not been correlated.
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.
Neoss Proactive Implant (K083561)
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
SEP 5 2012
1
Section 5: 510(k) Summary
The following information is provided as required by 21 CFR § 807.87 for the Neoss
Tapered Implant 510(k) premarket notification.
Neoss Ltd Windsor House Cornwall Road, Harrogate, HG1 2PW, UK Johanne Hamill Phone: +44 (0) 1423 817733 , +46 (0)709 792 892 Fax: +44(0) 1423 817744 E-mail: Johanne.hamill@neoss.com
Contact:
Sponsor:
M Squared Associates, Inc. Cherita James 901 King Street, Suite 200 Alexandria, VA 22314 Ph. 703-562-9800 Ext 257 Fax. 703-562-9797
Manufacturing:
Implants
Elos AB Bäckedalsvägen 6 SE-540 16 Timmersdala, Sweden. Registration Number: 3003847101
Elos Medtech Pinol AS Engsvej 33 DK-3330 Gorlose, Denmark. Registration Number: 3007689689
Packaging Facility
Wesley Coe Ltd Gas Lane Ely, Cambridgeshire CB7 4GH, UK Registration Number: 8044131
Sterilization Facility Swann-Morton Ltd Owlerton Green Hillsborough, Sheffield, S6 2BJ, UK Registration Number: 9611194
Date of Submission: November 14, 2011
1
Proprietary Name: Neoss Tapered Implant Common Name: Dental implant Regulatory Class: Class II Product Codes: DZE Regulation: 872.3640 Implant, Endosseous, Root Form Predicate Device(s): Neoss Proactive Implant (K083561)
Device Description:
The Neoss Tapered Implant is a threaded, internal abutment connection, root-form titanium dental implant. The Neoss Tapered Implant consists of a number of implants with a diameter of Ø3.5 to Ø5.5 mm and lengths between 7.0 – 17.0 mm; all sizes have the same internal abutment connection dimension independent of implant diameter.
The internal connection is equipped with interlocking elements for an insertion tool and the non-rotational locking of the abutment. The Neoss ProActive Tapered Implant System is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices, which can restore chewing function and aesthetic appearance. Supplied sterile.
The Neoss Implant System has specific design characteristics for mating Neoss components such as implants, abutments and prosthetic components. Combining components that are not configured or dimensioned for correct mating can lead to mechanical failure of components, damage to tissue, or unsatisfactory esthetic results. Abutment screws made in gold alloy, titanium or Ti with TiN/Au are available. Screw driver connection is compatible with screwdrivers supplied by Neoss. The abutment screws are supplied non-sterile.
Indication for Use:
The Neoss Tapered Implant is for single-stage or two-stage surgical procedure and cement or screw retained restorations.
The Neoss Tapered Implant is intended for immediate placement and function on single tooth and /or multiple tooth applications recognizing sufficient bone stability and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.
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2
Summary of Technological Characteristics:
The line extension to the Neoss ProActive Implant includes an assortment of tapered sizes. Tapered designs more closely reflect the shape of the tooth root. In animal testing, gritblasted and acid-etched surfaces exhibit an increase in the strength of osseointegration when compared to machined surfaces. Additionally, in animal testing, grit-blasted and acid-etched surfaces exhibit an increased bone to implant contact when compared to grit-blasted surfaces.
Summary of Performance Testing:
Performed fatigue tests of ProActive implants (K083561) shows results well in line with requirements. Clinical feedback and only one fracture related complaint confirms that the implant strength is adequate. The design in critical areas shows enough similarity between the two implant types to conclude that Neoss Tapered Implants will show equivalent results as for ProActive Implants in a fatigue test.
The Neoss Tapered Implant has an enhanced primary stability, i.e. mechanical stability at time of insertion as measured by in vitro insertion, displacement, and theoretical implantbone contact analysis, compared to a straight Neoss implant. This testing of primary stability and long term clinical outcome has not been correlated.
Conclusion:
The modified Neoss Tapered Implant has the following similarities to the Neoss ProActive Implant previously cleared in K083561:
- uses the same operating principle,
- incorporates the same basic design, -
- incorporates the same materials,
- incorporates the same surface characteristics and -
- has similar packaging and is sterilized using the same materials and processes -
Therefore the modification to the Neoss Tapered Implant can be found substantially equivalent to the Neoss ProActive Implant.
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3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
5 2012
SED
Neoss Limited
C/O Ms. Cherita James
Regulatory Consultant
M Squared Associates, Incorporated
901 King Street, Suite 200
Alexandria, Virginia 22314
Re: K113376
Trade/Device Name: Neoss Tapered Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: August 20, 2012 Received: August 22, 2012
Dear Ms. James:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Eederal Register.
4
Page 2- Ms. James
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 (OS) 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
For
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
112276
Section 4: Indications for Use Statement
510(k) Number: To be assigned
Device Name: Neoss Tapered Implant
Indications for Use: The Neoss Tapered Implant is for single-stage or two-stage surgical procedure and cement or screw retained restorations.
The Neoss Tapered Implant is intended for immediate placement and function on single tooth and /or multiple tooth applications recognizing sufficient bone stability and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.
Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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 Ruorrer
(Division Sign-Off) Division of Anestheslology, General Hospital Infection Control, Dental Device
510(k) Number: K113376
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