(153 days)
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No
The 510(k) summary describes a physical medical device (a titanium screw) and its intended use in dental procedures. There is no mention of software, algorithms, image processing, AI, ML, or any related concepts. The performance study is based on a clinical study, not algorithmic performance.
No.
The device is described as a self-tapping titanium threaded screw used for transitional applications in dentistry, primarily for stabilizing prostheses and facilitating healing, rather than directly treating a disease or condition for therapeutic purposes.
No
Explanation: The device is described as a self-tapping titanium threaded screw used for transitional applications in dentistry, such as supporting prostheses or stabilizing interim prostheses. Its function is to provide mechanical support and fixation, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states it is a "Self-capping titanium threaded screw," which is a physical hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The provided information clearly describes a surgical implant (a self-tapping titanium threaded screw) intended for placement within the body (intra-bony and inter-radicular) to provide structural support for dental prostheses.
The device's function is mechanical and structural, not diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
To provide immediate transitional splinting stability or ongoing fixation of new/existing crown, bridge & denture installations in parcial or fully edentulous sectings
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
Self-capping citanium threaded screw, 1.8mm in width by 14,17,19,&22mm lengchs
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
intra-bony and inter-radicular
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Dentatus MIIE Anchor Post/Modular Transicional Implant
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.
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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).
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§ 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
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) |