(701 days)
No
The description focuses on the physical characteristics, materials, and intended use of a dental implant, with no mention of AI or ML capabilities.
Yes
The device is intended to support prosthetic devices to restore the patient's chewing function, which is a therapeutic purpose.
No
Explanation: The device is a dental implant intended for placement in the bone to support prosthetic devices and restore chewing function, not for diagnosing conditions.
No
The device description clearly states it is a physical dental implant made of titanium alloy, available in various sizes, and includes physical abutments. It is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The provided text clearly describes a dental implant intended for surgical placement in the jawbone to support prosthetic devices. It is a physical implant used in vivo (within the body) to restore function.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, diagnostic purposes, or any of the typical components or functions of an IVD.
This device is a medical device, specifically a dental implant, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Star/Vent Internal Hex Screw Implant is intended for placement in the bone of the upper or lower jaw to support prosthetic devices such as artificial teeth, crowns, bridges or overdentures in edentulous or partially edentulous patients and to restore the patient's chewing function. It is intended for immediate loading when good primary stability has been achieved and with appropriate occlusal loading,
Product codes
DZE, NHA
Device Description
The Park Star/Vent Internal Hex Screw Implant is a root form endosseous dental implant (FDA classification code DZE). It has been placed in class 2 per 21 CFR 872.3640. The device is fabricated from titanium alloy meeting the specifications of ASTM F136. It is available in lengths of 8, 10, 11.5, 13, and 16mm and diameters of 3.3, 3.75, 4.2, 5.0 and 6.0mm. The surface is treated with resorbable blast media. The device is provided sterile. Sterility is achieved by gamma radiation pursuant to ISO 11137 to provide a sterility assurance level (SAL) of 10- This device includes straight abutments with a 1, 2, 3, or 4mm collar and a straight UCLA cast abutment with a titanium base. These abutments are composed of titanium alloy meeting the specifications of ASTM F-136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the upper or lower jaw
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)
Alpha Bio (K063364), 3i Osseotite (K022009, K022113 Mis (K04007, K003191)
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
510(k) Summary
- Applicant's Name and Address 1.
Submitted by:
Trade Name: Common Name: Classification Name:
Name of the Device:
- ని. Substantial Equivalence:
Park Dental Research Corp. 19 West 34th Street (Suite 301) New York NY 10001
AUG 2-6 2010
Daniel J. Manelli Manelli & Fisher, P.L.L.C. 5335 Wisconsin Avenue NW (Suite 440) Washington, DC 20016 Telephone: 202-885-5548
StarNent Internal Hex Screw Implant Endosseous dental implant Endosseous dental implant
Alpha Bio (K063364) 3i Osseotite (K022009, K022113 Mis (K04007, K003191)
-
বেঁ Description of the Device
The Park Star/Vent Internal Hex Screw Implant is a root form endosseous dental implant (FDA classification code DZE). It has been placed in class 2 per 21 CFR 872.3640. The device is fabricated from titanium alloy meeting the specifications of ASTM F136. It is available in lengths of 8, 10, 11.5, 13, and 16mm and diameters of 3.3, 3.75, 4.2, 5.0 and 6.0mm. The surface is treated with resorbable blast media. The device is provided sterile. Sterility is achieved by gamma radiation pursuant to ISO 11137 to provide a sterility assurance level (SAL) of 10- This device includes straight abutments with a 1, 2, 3, or 4mm collar and a straight UCLA cast abutment with a titanium base. These abutments are composed of titanium alloy meeting the specifications of ASTM F-136. -
- Intended use of the device
The Star/Vent Internal Hex Screw Implant is intended for placement in the bone of the upper or lower jaw to support prosthetic devices such as artificial teeth, crowns, bridges or overdentures in edentulous or partially edentulous patients and to restore the patient's chewing function. It is intended for immediate loading when good primary stability has been achieved and with appropriate occlusal loading,
- Intended use of the device
-
Basis for Substantial Equivalence 6.
The Star/Vent Internal Hex Screw Implant is substantially equivalent to the above identified implants from the standpoint of material composition, implant dimensions (e.g., AlphaBio K063364: lengths 8, 10, 11.5, 13. 16mm; diameters 3.3, 3.7, 4.2, 5.0mm), surface treatment and indications for use. It incorporates o.o, o.o. , t.e., characteristics, unique indications or materials as compared with the predicate devices.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Park Dental Research Corporation C/O Mr. Daniel J. Manelli Manelli & Fisher, P.L.L.C. 5335 Wisconsin Avenue NW, Suite 440 Washington, DC 20015
AUG 2 6 2010
Re: K082800
Trade/Device Name: Star/Vent Internal Hex Screw Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: August 23, 2010 Received: August 24, 2010
Dear Mr. Manelli:
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 Federal Register.
2
Page 2- Mr. Manelli
· 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/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.
Wh 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
3
Indications for Use
510(k) Number: K082800
Device Name: Star/Vent Internal Hex Screw Implant
Indications for Use:
The Star/Vent Internal Hex Screw Implant is intended for placement in the bone of the upper or lower jaw to support prosthetic devices such as artificial teeth, crowne, bridges or overdentures in edentulous or partially edentulous patients and to restore the patient's chewing function. It is intended for immediate loading when good primary stablily has been achieved and with appropriate occlusal loading,
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Kein Muluy for MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K082800 |
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