(684 days)
No
The summary describes a standard dental implant made of titanium alloy with no mention of AI or ML capabilities.
Yes
The device is described as supporting prosthetic devices and restoring chewing function, which are therapeutic benefits.
No
The device is a dental implant used to support prosthetic devices, not to diagnose medical conditions.
No
The device description clearly states it is a physical dental implant fabricated from titanium alloy, available in various lengths and diameters, and provided sterile. This indicates a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a dental implant, which is a physical device surgically placed into the bone of the jaw. It is used to support prosthetic devices and restore chewing function.
- Intended Use: The intended use clearly states the device is for placement in the bone of the jaw to support prosthetic devices. This is a surgical implant, not a diagnostic test performed on a sample.
The description focuses on the physical characteristics of the implant, its material, dimensions, surface treatment, and sterilization method. There is no mention of analyzing biological samples or providing diagnostic information.
N/A
Intended Use / Indications for Use
The Sargon Non-Expandable Dental Implant is indicated for immediate placement or delayed placement in the bone of the upper or lower jaw to support prosthetic devices such as artificial teeth, crowns, bridges or overdentures in partially or fully edentulous patients and to restore the patient's chewing function. This device is not indicated for immediate loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The Sargon Non-Expandable implant is a root form endosseous dental implant (FDA classification code DZE). It has been placed in class 2 per (1 DA Classification code DEE). is fabricated from titanium alloy meeting the specifications of ASTM F136. It is available in lengths of 8, 10, 13, and 16mm and diameters of 4.3 and 5.1mm. The surface is grit blasted and acid etched. The device is provided sterile. Sterility is achieved by gamma radiation pursuant the devilos provide a sterility assurance level (SAL) of 10°.
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): 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.
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
510(k) Summary
- Applicant's Name and Address 1.
Sargon Enterprises, Inc. 16101 Ventura Blvd. (Suite 350) JUL 2 1 2010 Encino, CA 91436
Submitted by:
Daniel J. Manelli Manelli & Fisher, P.L.L.C. 5335 Wisconsin Avenue NW (Suite 440) Washington, DC 20016 Telephone: 202-885-5548
- Name of the Device: 2.
| Trade Name: | Sargon Non-Expandable Dental Implant™ |
|---|---|
| Common Name: | Endosseous dental implant |
| Classification Name: | Endosseous dental implant |
- Substantial Equivalence: 3.
Strauman ITI (K012757, K003271 and K033984) Sargon implants (K930071, K961005 and K981141)
Description of the Device র্ধ .
The Sargon Non-Expandable implant is a root form endosseous dental implant (FDA classification code DZE). It has been placed in class 2 per (1 DA Classification code DEE). is fabricated from titanium alloy meeting the specifications of ASTM F136. It is available in lengths of 8, 10, 13, and 16mm
specifications of ASTM F136. It is available in lengths of 8, 10, 13, and 16mm specifications of AOTHIT Too: "It is arranames is grit blasted and acid etched.
and diameters of 4.3 and 5.1mm. The surface is grit blasted and acid etched. and diameters of 4.3 and 0. mini. The Januseved by gamma radiation pursuant
The device is provided sterile. Sterility is achieved by gamma radiation pursuant the devilos provide a sterility assurance level (SAL) of 10°
-
Intended use of the device 5.
The device is indicated for immediate placement or delayed placement in the The device is indicated for immediate proventiestic devices such as artificial bone of the upper of lower jaw to support province is not indicated for teeth, crowns, bridges or overdentares in partially in this device is not indicated for immediate loading. -
Basis for Substantial Equivalence ്.
The Sargon Non-Expandable Dental Implant is substantially equivalent to the The Sargon Non-Expandable Dental Innplants from the standard of material composition,
above identified Strauman implants from the stands of material composition, above Identified Strauman K033984; lengths 8, 10, 13, 16; diameters
implant dimensions (e.g., Strauman K03398; lengths 8, 10, 13, 16; disco substantially implant dimensions (e.g., Strainlan Roooo in Singinee. It is also substantially 3.3, 4.1, 4.6), sunace treatment and individual or able implant. It incorporates
equivalent to the previously cleared Sargon expandable implant. It incorporates equivalent to the previously cloured ourgue indications or materials as compared with the predicate devices.
revised 7/14/10
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 2 1 2010
Sargon Enterprises, Incorporated C/O Mr. Daniel J. Manelli Manelli & Fisher, P.L.L.C. 5335 Wisconsin Avenue NW, Suite 440 Washington, DC 20015
Re: K082573
Trade/Device Name: Sargon Non-Expandable Dental Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: July 15, 2010 Received: July 16, 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.
"The information in this document is for informational purposes only and does not constitute legal advice."
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 vours.
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 (if known): K082573
Device Name: Sargon Non-Expandable Dental Implant
Indications for Use:
The Sargon Non-Expandable Dental Implant is indicated for immediate placement or delayed placement in the bone of the upper or lower jaw to support prosthetic devices such as artificial teeth, crowns, bridges or overdentures in partially or fully edo ntulous patients and to restore the patient's chewing function. This device is not indicated for immediate loading.
Prescription Use X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
AND/OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
tion(ODE)
Kei. Marley for MCR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: