(88 days)
Not Found
No
The summary describes a dental implant system and its components, focusing on materials, dimensions, and mechanical properties. There is no mention of software, algorithms, or any features indicative of AI/ML technology.
Yes
The device is a dental implant system intended to restore chewing function, indicating a therapeutic purpose.
No
The device description indicates it is an implant system used for surgical procedures and prosthetic rehabilitation, not for diagnosing medical conditions.
No
The device description clearly details physical components such as implants, abutments, and bone cutting instruments, indicating it is a hardware-based medical device.
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 dental implant system used for surgical procedures and prosthetic restorations to restore chewing function. This is a medical device used in vivo (within the body), not in vitro (outside the body) for diagnostic purposes.
- Device Description: The description details a physical implant, abutments, and surgical instruments. These are all components of a medical device used for implantation and restoration, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
Therefore, the Neoss Implant System Ø3,25 is a medical device, specifically a dental implant system, and not an IVD.
N/A
Intended Use / Indications for Use
The Neoss Implant System Ø3,25 is for single-stage and two-stage surgical procedures and cement or screw retained restorations.
The Neoss Implant System Ø3,25 is intended for immediate loading on single tooth and for multiple tooth applications recognizing sufficient bone stability and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.
The Neoss Implant Ø3,25 abutments are designed to be connected to the Neoss implants and intended for use as an aid in prosthetic rehabilitation.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The Neoss Implant System Ø3,25 assortment consists of a number of implants with a diameter of Ø3,25 mm and lengths between 9,0 - 17.0 mm having the same internal abutment designs as previously cleared per K083561 & K043195 & K071838, but a smaller diameter and includes a selection of abutments.
Identical to K043195 & K083561, the Neoss Implant System Ø3,25 remains a threaded, internal abutment connection, root-form titanium dental implant. The internal connection being equipped with interlocking elements for an insertion tool and the non-rotational locking of the abutment. Smaller associated bone cutting instruments are also available. The Neoss Implant System Ø3,25 available surface treatment will be identical to either the Neoss Bimodal or Neoss ProActive Implant. Supplied sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Based on the Risk Analysis, performance testing and fatigue testing was conducted to confirm compliance to device specifications and recognized standards; all functions were verified to operate as designed.
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 Bimodal Implant K043195, Neoss ProActive Implant K083561 and Neoss Abutment System K071838.
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.
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Section 6: 510(k) Summary
Applicant:
יר
Neoss Ltd Windsor House Cornwall Road Harrogate, HG1 2PW, UK Johanne Hamill Phone: +44 (0) 1423 817733 , +44 (0) 7766913429 Fax: +44(0) 1423 817744 E-mail: Johanne.hamill@neoss.com Registration Number: 3005846524
US Contact:
Cherita James M Squared Associates, Inc. 901 King Street, Suite 200 Alexandria, Virginia 22314 Phone: 703-562-9800 Ext. 257 Facsimile: 703-562-9797
Manufacturing:
Implants, abutments and abutment screws
Elos AB Bäckedalsvägen 6 SE-540 16Timmersdala, Sweden. Registration Number: 3003847101
Pinol AS Engsvei 33 DK-3330 Gorlose, Denmark. Registration Number: Not yet available
Samaplast AG Neugruetstr 3 St Margrethen SG CH 9430 Registration Number : Not yet available
Packaging Facility
Wesley Coe Ltd Gas Lane Ely, Cambridgeshire CB7 4GH, UK Registration Number: 8044131
Sterilization Facility
Swann-Morton Ltd
CONFIDENTIAL
MAY 22 2009
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Owlerton Green Hillsborough, Sheffield, S6 2BJ, UK Registration Number: 9611194
| Date submitted: | 19 February 2009 |
|---|---|
| Proprietary Name: | Neoss Implant System Ø3,25 |
| Common Name: | Dental implant |
| Classification Status: | Class II |
| Product Codes: | DZE, NHA |
| Regulation: | 872.3640 Implant, Endosseous, Root Form; 872.3630 Abutment, implant , dental, endosseous |
| Predicate Device: | Neoss Bimodal Implant K043195, Neoss ProActive Implant K083561 and Neoss Abutment System K071838. |
Device Description:
The Neoss Implant System Ø3,25 assortment consists of a number of implants with a diameter of Ø3,25 mm and lengths between 9,0 - 17.0 mm having the same internal abutment designs as previously cleared per K083561 & K043195 & K071838, but a smaller diameter and includes a selection of abutments.
Identical to K043195 & K083561, the Neoss Implant System Ø3,25 remains a threaded, internal abutment connection, root-form titanium dental implant. The internal connection being equipped with interlocking elements for an insertion tool and the non-rotational locking of the abutment. Smaller associated bone cutting instruments are also available. The Neoss Implant System Ø3,25 available surface treatment will be identical to either the Neoss Bimodal or Neoss ProActive Implant. Supplied sterile.
Indication for Use: The Neoss Implant System Ø3,25 is for single-stage and two-stage surgical procedures and cement or screw retained restorations. The Neoss Implant System Ø3,25 is intended for immediate loading on single tooth and for multiple tooth applications recognizing sufficient bone stability and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.
The Neoss Implant Ø3,25 abutments are designed to be connected to the Neoss implants and
CONFIDENTIAL
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intended for use as an aid in prosthetic rehabilitation.
Summary of Technological Characteristics:
.
The modification to the Neoss Bimodal Implant, since its previous clearance in K043195 and Neoss ProActive Implant , previously cleared under K083561 and Neoss Abutment cleared under K071838 are as follows:
- a) Diameter of Implant Thread 03.5 to 03.25
- b) Diameter of Abutment connection Ø4,0 to Ø3,5
- c) Outer Diameter of Abutment screw M2 to M1,6
- d) Smaller Countersink and Screw Tap instruments for compatibility with modified implant dimensions
These dimensional changes do not affect the safety nor performance of the device or instruments and do not change the intended use of the Neoss Implant System Ø3.25 when compared to Neoss Bimodal Implant, Neoss ProActive Implant and Neoss Abutments when used as intended. They allow the clinician a range of options comparable to other currently marketed devices in relation to narrow bone ridges & narrower mesio distal spaces.
Summary of Nonclinical Testing:
Based on the Risk Analysis, performance testing and fatigue testing was conducted to confirm compliance to device specifications and recognized standards; all functions were verified to operate as designed.
Substantial Equivalence Discussion:
The introduction of the Neoss Implant System Ø3,25 does not change the intended use nor does it affect the safety and effectiveness as compared to the Neoss Bimodal Implant previously cleared in K043195 and Neoss ProActive Implant, previously cleared in K083561 and Neoss Abutments , previously cleared in K071838. Performance of the modified device is as safe and effective as other currently marketed devices of comparable dimension.
Conclusion:
The introduction of Neoss Implant System Ø3,25 has the following similarities to the Neoss Bimodal Implant previously cleared in K043195 and Neoss ProActive Implant previously cleared in K083561 and Neoss Abutments , previously cleared in K 071838:
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has the same indicated use, .
ﺎﻧﺘ -
uses the same operating principle, .
-
. incorporates the same basic device design and physical properties,
-
incorporates the same materials. .
Therefore, the Neoss Implant System Ø3,25 is substantially equivalent to the predicate devices.
CONFIDENTIAL
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three stylized wing strokes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 2009
Neoss Limited C/o Ms. Cherita James Regulatory Consultant M Squared Associates, Incorporated 901 King Street, Suite 200 Alexandria, Virginia 22314
Re: K090452
Trade/Device Name: Neoss Implant System Ø3,25 Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: May 19, 2009 Received: May 20, 2009
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.
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 Federal Register.
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
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Page 2- Ms. James
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Rare
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 5: Indications for Use Statement
510(k) Number (if known): K090452
Device Name: Neoss Implant System Ø3,25 Indications For Use:
The Neoss Implant System Ø3,25 is for single-stage and two-stage surgical procedures and cement or screw retained restorations.
The Neoss Implant System Ø3,25 are intended for immediate loading 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. The Neoss Implant Ø3,25 abutments are designed to be connected to the Neoss implants and intended for use as an aid in prosthetic rehabilitation.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ 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)
Page 1 of __ 1_
Rai Muelly for MSA
on Sian-Off) (Divi Division of Anesthesiology, General Hospital Infection Control, Dental Devices
090452 510(k) Number:
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