(336 days)
No
The summary describes mechanical instruments for dental implant placement and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device components (Parallel Pin, Depth Gauge, Surgical Ratchet) are instruments used for the placement of a dental implant, facilitating the surgical procedure rather than directly providing a therapeutic effect on the patient.
No
This device is described as an instrument used in the placement of a dental implant, including tools for vertical placement, measuring depth, and screwing the implant. It does not perform any diagnostic function.
No
The device description explicitly lists physical instruments (Parallel Pin, Depth Gage, Surgical Ratchet) used in a surgical procedure, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the product's function in the placement of a dental implant. This is a surgical procedure performed in vivo (within the body), not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description reinforces the use of the instruments (Parallel Pin, Depth Gauge, Surgical Ratchet) in the surgical process of implant placement.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
The device is a set of surgical instruments used in a dental procedure, not a diagnostic test.
N/A
Intended Use / Indications for Use
This product is designed for use in the placement of the "Dual Integrator" Dental Implant (K944225).
The Parallel Pin is used to insure correct vertical placement of the implant. The Depth Gauge is used to measure the depth of surgical site, while the Surgical Ratchet is used to screw the "Dual Integrator" Dental Implant into the surgical site.
These products along with the "Dual Integrator" Dental Implant make up the total system of tooth replacement by Implant Integration Systems.
Product codes
DZE
Device Description
The "Dual Integrator" Parallel Pin, Depth Gage, and Surgical Ratchet are all intended to be used with the Implant Integration Systems "Dual Integrator" Dental Implant (K944225).
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K944225, K904707, K902911, K903115, K874590
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
Implant Integration Systems, Inc.
6161 Clark Road, Suite 8 • Paradise, CA 95969 USA • (916) 872-1020 • Fax: (916) 877-7555
970572
Summary of Safety and Effectiveness Information
The "Dual Integrator" Parallel Pin, Depth Gage, and Surgical Ratchet are all intended to be used with the Implant Integration Systems "Dual Integrator" Dental Implant (K944225).
This product is similar in design, composition (stainless steel) and function to the Minimatic Implant Tech. BC 1208 (K904707), the Impla-Med, Inc. Stainless Steel Instruments (K902911), the Minimatic Implant Tech. DG-1109 Depth Gage (K903115), the Implant Innovations Int. Innovative Implants and Cover Screws (K874590), as well as, parallel pins, depth gauges and surgical ratchets from any other implant system.
Cory D. Hanosh, Sales Manager
Date
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Corey D. Hanosh ·Sales Manager Implant Integration System, Incorporated 6161 Clark Road, Suite 8 Paradise, California 95969
JAN 16 1998
K970572 Re : "Dual Integrator" Dental Implant Accessories Trade Name: Parallel Pin Regulatory Class: III Product Code: DZE February 11, 1997 Dated: Received: February 14, 1997
Dear Mr. Hanosh:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
2
Page 2 - Mr. Hanosh
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
3
Implant Integration Systems, Inc.
6161 Clark Road, Suite 8 • Paradise, CA 95969 USA • (916) 872-1020 • Fax: (916) 877-7555
Indications For Use
This product is designed for use in the placement of the "Dual Integrator" Dental Implant (K944225).
The Parallel Pin is used to insure correct vertical placement of the implant. The Depth Gauge is used to measure the depth of surgical site, while the Surgical Ratchet is used to screw the "Dual Integrator" Dental Implant into the surgical site.
These products along with the "Dual Integrator" Dental Implant make up the total system of tooth replacement by Implant Integration Systems.
Sincerely,
Cory D. Hanosh
Sales Manager
Susan Rummer
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K775572
Prescription Use Prescription 801.109)