(218 days)
The Posi-Stop/Posi-Trac System consists of 12 drills plus a starter drill utilized in osteotomy procedures before implant insertion. The Posi-Stop/Posi-Trac System is designed for use with or without a surgical guide. The system allows the dental practitioner to increase size gradations in 0.5mm steps for final sizing for implant type customization. The system is truly generic in that its 0.5mm size gradations allows the doctor to switch to a final sizing drill for implant type customization.
The Posi-Stop/Posi-Trac System consists of 12 drills plus a starter drill utilized in osteotomy procedures before implant insertion. The system is designed for use with or without a surgical guide and allows for size gradations in 0.5mm steps for final sizing for implant type customization. The system includes a 1.6mm starter drill, Posi-Trac drills, and Posi-Stop instruments. The 1.6mm drill is the only depth cutting instrument, while the remaining drills cut only on the outer 0.5mm to prevent excessive depth penetration. The Posi-Trac drill has a pilot end of 1.6mm and is used to widen the osteotomy. The Posi-Stop instrument is utilized until the correct width is achieved. The Posi-Stop can be adjusted along a track guide. The 2.0 - 4.5mm sizes are safety ended.
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental medical device. It does not contain any information about acceptance criteria or a study that proves the device meets specific criteria (such as performance metrics, sample sizes, expert qualifications, or ground truth establishment).
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given information. The document focuses on regulatory approval and classification, not on the technical performance study details.
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Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 1999
Ms. Marci Bloom President The Dental Medical Device Company, L.L.C. 39 Aynsley Court Montville, New Jersey 07045
Re : K981997 Trade Name: Posi-Stop/Posi-Trac System Regulatory Class: III Product Code: DZE Dated: October 8, 1998 October 14, 1998 Received:
Dear Ms. Bloom:
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 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). 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, qood 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. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. 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
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Page 2 - Ms. Bloom
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral 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.gov/cdrh/dsma/dsmamajn.html".
sincerely yours,
Timothy A. Ulatowski
Timo A Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Device Name: Posi-Stop/Posi-Trac System
Indications For Use:
The Posi-Stop/Posi-Trac System consists of 12 drills plus a starter drill utilized in osteotomy procedures before implant insertion.
The Posi-Stop/Posi-Trac System is designed for use with or The system allows the dental without a surgical guide. practitioner to increase size gradations in 0.5mm steps for final sizing for implant type customization.
(continued p. 2)
(PLEASE DO NOT WRITE BILLOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
O
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division {lign-Of
Divisional Dental, Infection Control,
and Gener of Horspital Devices
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Suver Ramper
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number .
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510K Number: K981997 Device Name: Posi-Stop/Posi-Trac System Indications for Use con't. p. 2
The Posi-Stop/Posi-Trac System is designed for use with or without a surgical guide. The system is truly generic in that its 0.5mm size gradations allows the doctor to switch to a final sizing drill for implant type customization.
- Osteotomy preparation is begun with a 1.6mm starter drill. The depth of the preparation should pierce the outer cortical bone and be about 5mm in depth. If a surgical drill guide is used, the guide tube should have an inside diameter of 1.6mm and the starter drill should be tested in the guide tube to be certain that binding does not occur.
*The length adjusted 1.6mm drill is placed into the osteotomy preparation and to the correct depth. It must be remembered the 1.6mm drill is the only depth cutting instrument; the remaining drills cut only on the outer 0.5mm to prevent excessive depth penetration. It is recommended that the osteotomy be prepared 1-2mm deeper than the length of the implant to allow for the exact placement of the coronal aspect of the implant in relation to the crestal bone.
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After the 1.6mm osteotomy is prepared, a 2mm Posi-Trac drill is utilized. The pilot end of this instrument is 1-6mm (the diameter of the previous drill) and will fit easily into the osteotomy. The Posi-Trac drill is 8mm in length and should be used only to widen the osteotomy to the next drill size. It should not be taken to length. After use of the Posi-Trac, the next length adjusted Posi-Stop instrument will be utilized until the correct width is achieved.
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Should during the course of preparation, the Posi-Stop (PSD 2) not fit interdentally, it may be removed by moving the Posi-Stop (PSD 2) to the colored size indicator ring (PSD 10) along the track guide (PSD 5). The stop is rotated away from the operator until the locking screw assembly (PSD 2b) is on the drill flute, then removed by pulling it along the drill flute and over the cutting end. The Posi-Stop is simply replaced by reversing the procedure. The osteotomy can still be prepared safely since the 2.0 - 4.5mm sizes are safety ended.
§ 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.