(153 days)
This device is a self-tapping titanium threaded screw indicated for intra-bony and inter-radicular transitional applications, to permit immediate splinting stability and ongoing fixation of new or existing crown & bridge installations, for full or partial edentulism, and employing minimally invasive surgical intervention.
Representative applications include the following:
- t Temporary (transitional) supports for fixed or removable implant-supported prostheses while conventional implants are integrating .
-
- Stabilizing interim prostheses in graft sites and guided tissue regeneration applications to avoid iatrogenic damage to healing grafts, membranes Ox integrating implants.
- 本 Introductory system for nervous or apprehensive potential implant patients, offering a simple methodology for testing out the actual "feel" of boneanchored implants, without the major committment to final restorations; or as an interim system for medically compromised, handicapped or terminally ill patients to enhance their comfort by maintaining a reasonable level of speech, mastication & general well-being, at modest cost levels.
Self-capping citanium threaded screw, 1.8mm in width by 14,17,19,&22mm lengchs
The provided text is a premarket notification summary (510(k)) for a dental implant, not a study describing acceptance criteria and device performance in the way typically seen for diagnostic or AI-driven medical devices. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance metrics against specific acceptance criteria.
Therefore, many of the requested categories (e.g., specific acceptance criteria, sample sizes for test and training sets, expert qualifications, MRMC studies, standalone performance) are not applicable or cannot be extracted from this type of document.
However, I can provide available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Dentatus MIIE Anchor Post) in terms of: | Device is a self-tapping titanium threaded screw comparable in biocompatible titanium materials, manufacture, sterilization methods, and intended applications to the predicate. |
| - Biocompatible materials | Comparable biocompatible titanium materials. |
| - Manufacture | Comparable manufacture. |
| - Sterilization methods | Comparable sterilization methods. |
| - Intended applications | Comparable intended applications. |
| Safety and efficacy (survival) | Demonstrated consistent quality and quantity of survival over 20 years. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a "test set" in the context of typical device performance evaluations. The clinical data is based on a "twenty year prospective clinical study." The exact number of patients or implants is not provided.
- Data Provenance: The study "commencing in 1976 by Sendax & associates" suggests the data is prospective and collected over a long period. The country of origin is not explicitly stated but "Sendax MDIC Management, Inc." and "New York, N.Y." might imply US-based data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The study appears to be a clinical outcome study, not one requiring expert consensus for a ground truth label in the diagnostic sense.
4. Adjudication method for the test set:
- Not applicable as the study type does not involve a "test set" requiring adjudication in this manner.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a dental implant, not an AI-driven diagnostic tool. No MRMC study was performed, and human readers are not involved in its "performance."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device (dental implant), not an algorithm.
7. The type of ground truth used:
- The "ground truth" implicitly refers to the clinical outcomes of the dental implants, specifically their "survival" over 20 years, confirming safety and efficacy.
8. The sample size for the training set:
- Not applicable. This is not a machine learning model. The clinical data constitutes the "study data" rather than a "training set."
9. How the ground truth for the training set was established:
- Not applicable. The ground truth (clinical survival) was established through direct observation and follow-up in the "twenty year prospective clinical study."
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PREMARKET NOTIFICATION [510(k)} SUMM
Safe Medical Devices Act Summary of Safety and Effectiveness
Submitter: Sendax MDIC Management, Inc. NOV 2 4 1997 Address: 30 Central Park South - Suite 14B New York, N.Y. 10019 Phone: (212)753-2775 Fax: (212)753-9064 Contact Person: Dr. Victor I. Sendax Date of Summary Preparation: May 31,1997 Endosseous Dencal Implant 76D2E Classification Name & Number:
Common/Usual Name: Dencal Anchor Post/Endodontic Splint-Stabilizer/ Mini Transitional Implanc Name of Device: Mini Dental Implant, cp titanium or citanium alloy Proprietary (Trade) Name: Sendax MDI D
Legally Marketed Device Claimed As Subscantially Equivalenc: Dentatus MIIE Anchor Post/Modular Transicional Implant
Description of Device: Self-capping citanium threaded screw, 1.8mm in width by 14,17,19,&22mm lengchs
Intended Use of Device:To provide immediate transitional splinting stability or ongoing fixation of new/existing crown, bridge & denture installations in parcial or fully edentulous sectings
Technological Characteristics: Comparable biocomparable titanium mater+ ials, manufacture, sterilization methods, and intended applications
Clinical performance dara: Based on a twenty year prospective clinical study commencing in 1976 by Sendax & associates, demonstrating consistent quality as well as quancity of survival, confirming safety and efficacy of the Sendax insertion/reconstructive profocol
Decision Tree: Based on the 510X substantial equivalence decision-making process from ODE Guidance Memo No. 86-3
End of Summary
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three intertwined strands. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircle the caduceus, indicating the department's name and national affiliation. The seal is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 1997
Victor I. Sendax, DDS ·President & CEO Sendax MDIC Managemner, Incorporated 30 Central Park South, Suite 4B New York, New York 10019
Re : K972351 Sendax MDI (Mini Dental Implant) Trade Name: Regulatory Class: III Product Code: DZE Dated: October 3, 1997 Received: October 6, 1997
Dear Dr. Sendax:
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 requlations 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 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 regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 - Dr. Sendax
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) 594-4618. 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,
K. Kitatrust
Timoghy 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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510(k) Number: 972351
Device Name: SENDAX MINI DENTAL IMPLANT (MDI)
This device is a self-tapping titanium threaded screw Indications For Use: indicated for intra-bony and inter-radicular transitional applications, to permit immediate splinting stability and ongoing fixation of new or existing crown & bridge installations, for full or partial edentulism, and employing minimally invasive surgical intervention.
Representative applications include the following:
- t Temporary (transitional) supports for fixed or removable implant-supported prostheses while conventional implants are integrating .
-
- Stabilizing interim prostheses in graft sites and guided tissue regeneration applications to avoid iatrogenic damage to healing grafts, membranes Ox integrating implants.
- 本 Introductory system for nervous or apprehensive potential implant patients, offering a simple methodology for testing out the actual "feel" of boneanchored implants, without the major committment to final restorations; or as an interim system for medically compromised, handicapped or terminally ill patients to enhance their comfort by maintaining a reasonable level of speech, mastication & general well-being, at modest cost levels.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | |
| Prescription Use (Per 21 CFR 801.109) | OR |
| Over-The-Counter Use | |
| (Optional Format 1-2-96) |
§ 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.