(891 days)
K-853788, K-830404, K-924112
K-820013, K-853788, K-861426, A, B, K-892124A, K-852802, K-884845, K-891346, K-895267, K-924112, K-931767, K-974401
No
The summary describes a standard dental implant device made of titanium or titanium alloy, with no mention of AI or ML capabilities in its design, function, or intended use.
Yes
The device is intended to restore the patient's chewing function, which is a therapeutic purpose.
No
The device is intended to provide support for prosthetic devices and restore chewing function, not to diagnose a condition.
No
The device description explicitly states it is a screw-type endosseous dental implant made of titanium or titanium alloy, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices... and to restore the patient's chewing function." This describes a device that is implanted directly into the body for a therapeutic purpose (restoring function and supporting prosthetics).
- Device Description: The description details a "screw-type endosseous dental implant" made of titanium or titanium alloy. This is a physical implant designed to be placed within the bone.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze biological specimens in this way.
The device described is a dental implant, which is a type of medical device used in surgery.
N/A
Intended Use / Indications for Use
These devices are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices and to restore the patient's chewing function.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The Quantum Versatility Implants are screw-type endosseous dental implants with design and manufacturing concepts, materials, surgical procedures, and intended uses quite similar to the preamendment device and to others rated substantially equivalent to the preamendment device. The Quantum Implant system is most similar the DB Precision Implant system cleared in K-853788 which is very similar to the Titanaloy submersible implant system cleared in K-830414. Like many commercial implants, the Quantum devices are manufactured of high-purity (99+%) titanium, or titanium alloy (ASTM F 136-84 titanium - 6 aluminum - 4 vanadium). Quantum Implants also are available in coated form, either hydroxyapatite or titanium plasma spray. These devices are equivalent to various coated endosseous implants on the market, for example the Sabertech implants of Genentech, Inc., which were cleared under K-924112.
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 arches
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.
K-853788, K-830414, K-924112
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.
K-820013, K-853788, K-861426, A, B, K-892124A, K-852802, K-884845, K-891346, K-895267, K-924112, K-931767, K-974401
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.
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్రా మొద్ద
XIV. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA. (Separate Page)
A. Submitter: Raul R. Mena, Quantum BioEngineering, Ltd., 201 N. University Dr., Plantation, Florida, 33324
I. Classification Name and Number: Endosseous Implant (76DZE),
II. Common/Usual Name: Dental Implant, Endosseous, Post- or Screw-type, titanium or titanium alloy.
III. Proprietary Name: Quantum Versatility Implant System
IV. Classification: This device is being finally classified by the Dental Devices Panel (Title 21 CFR 872.3640.
V. Performance standards: None applicable. Materials meet ASTM voluntary standards
VI. Description: The Quantum Versatility Implants are screw-type endosseous dental implants with design and manufacturing concepts, materials, surgical procedures, and intended uses quite similar to the preamendment device and to others rated substantially equivalent to the preamendment device. The Quantum Implant system is most similar the DB Precision Implant system cleared in K-853788 which is very similar to the Titanaloy submersible implant system cleared in K-830414. Like many commercial implants, the Quantum devices are manufactured of high-purity (99+%) titanium, or titanium alloy (ASTM F 136-84 titanium - 6 aluminum - 4 vanadium). Quantum Implants also are available in coated form, either hydroxyapatite or titanium plasma spray. These devices are equivalent to various coated endosseous implants on the market, for example the Sabertech implants of Genentech, Inc., which were cleared under K-924112.
VII. Labels and Instructions for Use are provided, as are labels for competitive products.
VIII. Intended Use: These devices are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices and to restore the patient's chewing function.
IX. Substantial Equivalence: This device is equivalent to devices manufactured and sold before 1976,having a U. S. classification number of 76 DZE, and those described under 21 CFR 872.3640. It is also equivalent to several devices currently on the market that have been determined by the FDA to be substantially equivalent to the above preamendment devices. Some examples of other equivalent products are:
Bofors Nobelpharma, Goteborg, Sweden: Titanium Implant Device, K-820013; Boehringer/Miter Corp. of Warsaw, IN: Titanoloy P.S.I.; Driskell Bioengineering, Inc.,
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Westerville, OH: DB Precision Implants, K853788; Core-Vent Corp., Encino, CA: Screw-Vent Endosseous Implants, K-861426, A, B; Impla-med, Inc., Sunrise, FL: P.M.T. Surgical Implant Components, K-892124A: Steri-Oss (Subs. Denar, Anaheim, CA.). Denar Dental Implant, K-852802; Steri-Oss Implant, K-884845. Artech, Inc., Chantilly, VA: Artech Submerged Screw Implant, K-891346, K-895267; Genentech, Seattle WA: Sabertech, K-924112; Astra Tech Inc., Astra Tech Implants, K-931767; and Vancouver Implant Resources, Inc., Simpler One Threaded Implant, K-974401.
VIII. Clinical Discussion and Brief Literature Review. Endosseous implants, and especially those of titanium or titanium alloy, in the "post" or "screw" configuration, have been proved safe and effective through the years. The possible adverse effects summarized in this 510(k) cover those listed by the United States classification panel [Federal Register, vol. 45, No. 251, pp 86025-6, Dec. 30, 1980], as well as to those revealed in a recent literature search. Matukas, "Medical Risks Associated with Dental Implants," states, "Little or no hard data could be found on the medical risks associated with [dental] implants." Because of the wide-spread usage of dental implants, Smith and Zarb made a careful review of the literature and proposed criteria for implant success.
A thorough computerized Medline literature search produced 653 entries. An update of this search produced 111 new review articles. The Journal of Dental Education published a special issue "Proceedings of the Consensus Development Conference on Dental Implants [National Institutes of Health, Bethesda, MD, June 13-15, 1988], Vol. 52, No. 12, pp. 677-831, Dec. 1988. This added to the literature search above, with some especially pertinent reprints from the scientific literature, provide a comprehensive summary of available scientific data.
Zarb completed his report of the detailed Toronto 10-year study by concluding that "the tried and tested Branemark implant technique has revolutionized the treatment options open to the prosthodontist. For the edentulous patient...the prospect for a lifetime of restored oral comfort, function, and appearance have now become predictable and reliable." These results are ample evidence of the safety and effectiveness of these endosseous implants.
END OF 510(k) SUMMARY
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 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 edge. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight.
SEP 2 0 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Raul R. Mena, D.M.D. President Quantum BioEngineering, Ltd. 201 University Drive Suite 101 Plantation, Florida 34134
Re : K991250 Quantum™ Versatility Implant System Trade Name: Requlatory Class: III Product Code: DZE Dated: April 7, 1999 April 13,1999 Received:
Dear Raul R. Mena, D.M.D.:
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, Druq, 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Raul R. Mena, D.M.D.
this response to your premarket notification Please note: Please note: "Chis response co your action you might have under submission does not afreed any can for devices under the Sections 331 chrough 342 on one on one of other Federal laws or regulations.
This letter will allow you to begin marketing your device as This lecter will arrow you co respect notification. - The FDA described in your 510 kr prumence of your device to a legally finding of substancial equivalence of yolassification for your marketed predicate device robated in to proceed to the market.
If you desire specific advice for your device on our labeling II you desire specific additionally 809.10 for in regulation (21 crk Farss), please contact the Office of Vitto diagnostic devices), prouble one of accessor of the contact Compliance at (301) 354 1032 of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to the regulation encrease, Mibranding of 97). Other general premation on your responsibilities under the Act may be information on your responsible and Manufacturers Assistance obtained from the Division of 6:00 or (301) 443-6597 or at at its coll-free number (000)- oo =aa.gov/cdrh/dsmamain.html".
its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Pattacia Cusente for
Timothy 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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IX. Indications for Use: [Separate Page]
K991250 510(k) Number: 仙谷
Device Name: Quantum Versatility™ Implant System
This device 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, and to restore the patient's chewing function.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
or
Over-The-Counter Use __
(Optional Format 1-2-96)
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(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
***imber -