(105 days)
Not Found
No
The document describes a dental implant system and its components, with no mention of AI or ML technology in the intended use, device description, or specific sections for AI/ML information.
No
The device is described as an artificial tooth replacement system, which supports restorations, but it does not directly treat or prevent a disease or condition.
No
This device is described as an artificial tooth replacement system and its components (implants, abutments, screws) are intended for prosthetic support, not for diagnosing medical conditions.
No
The device description clearly states it is an "endosseous type artificial tooth replacement system," which are physical implants and associated hardware, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that the OsseoLink Dental Implant System is an "endosseous type artificial tooth replacement system." This means it is a physical implant placed within the body, not a device used to analyze samples outside the body.
- Intended Use: The intended use describes supporting dental restorations in the mouth, which is a surgical and prosthetic procedure, not a diagnostic test.
The information provided aligns with a medical device used for treatment and restoration, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Implant: OsseoLink dental implants are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The OsseoLink Dental System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. The placement of individual Ø 3.5 mm diameter implants in the molar region in not recommended.
Prosthetic Abutments, Cover Screws & Healing Abutments: OsseoLink prosthetic abutments are intended for use with OsseoLink dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. OsseoLink cover screws are used when submerged healing is desired in two stage implant surgery procedures. OsseoLink healing abutments are used at the time of implant placement when non-submerged (i.e., single-stage) surgical placement is indicated or following the uncovering of an implant when the two-stage protocol is followed.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The OsseoLink Dental Implant System is an endosseous type artificial tooth replacement system that is intended for use in prosthetic dentistry to support restorations that resemble a tooth or group of teeth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibles and maxillae
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.
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SECTION 5 - 510(k) SUMMARY
Submission Correspondent
Emergo Group, Inc.
OCT - 6 2009
1705 S. Capital of Texas Hwy Suite 500 Austin, TX 78746
Phone
Address
(512) 327-9997
Fax
(512) 327-9998
Contact
Stuart R. Goldman
Submission Sponsor
Global Implant Solutions, LLC 41 North Road Suite 207 Bedford, MA 01730 Tel: 781-232-9477 Fax: 781-275-2273
www.osseolink.com/
Date Prepared
May 11, 2009
Trade Name
OsseoLink Dental Implant System
1
Regulation Name(s)
-
- Endosseous Dental Implant
-
- Endosseous Dental Implant Abutment
Regulation Number(s)
-
872.3640
-
872.3630
Classification Name(s)
-
Implant, Endosseous, Root-Form
-
Abutment, Implant, Dental, Endosseous
Product Code(s)
-
DZE
-
NHA
Classification Panel
Dental Devices
Regulatory Class
Class II
Device Description
The OsseoLink Dental Implant System is an endosseous type artificial tooth replacement system that is intended for use in prosthetic dentistry to support restorations that resemble a tooth or group of teeth.
191878
Intended Use
Implants
OsseoLink dental implants are indicated for use in partially or fully edentulous
2
mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The OsseoLink Dental System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. The placement of individual Ø 3.5 mm diameter implants in the molar region in not recommended.
291878
Prosthetic Abutments, Cover Screws & Healing Abutments
OsseoLink prosthetic abutments are intended for use with OsseoLink dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. OsseoLink cover screws are used when submerged healing is desired in two stage implant surgery procedures. OsseoLink healing abutments are used at the time of implant placement when non-submerged (i.e., single-stage) surgical placement is indicated or following the uncovering of an implant when the two-stage protocol is followed.
Predicate Device(s)
-
- Suizer Dental, Inc. -- Screw Vent & Tapered Screw Vent -- (K013227)
-
- Nobel Biocare, LLC Groovy Implants (K050258)
Safety and Effectiveness
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics, and it can be demonstrated that the device is as safe and effective as the predicate device, and that the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device.
It has been shown in this 510(k) submission that the differences between the OsseoLink Dental Implant System and the predicate devices do not raise any questions regarding its safety and effectiveness. The OsseoLink system, as designed and manufactured, is as safe and effective as the predicate devices and therefore is determined to be substantially equivalent to the referenced predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
Global Implant Solutions, L.L.C. C/O Mr. Stuart R. Goldman Emergo Group, Incorporation 1705 South Capital of Texas Highway, Suite 500 Austin, Texas 78746
OCT - 6 2009
Re: K091878
Trade/Device Name: OsseoLink Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: September 21, 2009 Received: September 23, 2009
Dear Mr. Goldman:
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.
4
Page 2- Mr. Goldman
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 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
for
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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SECTION 4 - INDICATIONS FOR USE
j of 1
510(k) Number (if known): _
Device Name
OsseoLink Dental Implant System
Indications for Use
Implants
OsseoLink dental implants are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The OsseoLink Dental System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. The placement of individual Ø 3.5 mm diameter implants in the molar region in not recommended.
Prosthetic Abutments, Cover Screws & Healing Abutments
OsseoLink prosthetic abutments are intended for use with OsseoLink dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. OsseoLink cover screws are used when submerged healing is desired in two stage implant surgery procedures. OsseoLink healing abutments are used at the time of implant placement when non-submerged (i.e., single-stage) surgical placement is indicated or following the uncovering of an implant when the two-stage protocol is followed.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
Over-The-Counter Use_ AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page of
Kein Muelly for MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091878