(112 days)
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No
The 510(k) summary describes a mechanical dental abutment and does not mention any software, algorithms, or AI/ML capabilities.
No
Explanation: A therapeutic device is one that treats or prevents a disease or condition. This device, an angled crown post, is intended as a component for dental restorations (to support a cast crown), not to directly treat or prevent a disease. It functions as a structural component for a prosthesis, which is not considered therapeutic in the medical device context.
No
The provided text describes an "Opti-Max angled crown post for externally-hexed implants" which is used as an abutment for a cast crown. Its function is to retain a dental restoration, not to diagnose a condition or disease.
No
The device description clearly indicates a physical component ("angled crown post for externally-hexed implants") which is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states the device is an "angled crown post for externally-hexed implants" intended to be used as an abutment for a cast crown in dental procedures. This is a surgically implanted device used within the body, not for testing specimens outside the body.
The information provided focuses on the device's function in supporting a dental restoration within the mouth, which is characteristic of a medical device used in vivo, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Opti-Max angled crown post for externally-hexed implants is intended to be used as an abutment for a cast crown, to be retained by cementation. The metal for this cast crown is to be composed of a computible formulation when in contact with Ti6A4V. If light retention is desired by the cinician zinc-oxide cement can be used, if stronger retention is desired, carboxylate cements of an be used. The cast crown seated on this crown post may be single and free-sanding, part of fixed bridgework, or connected to a bar structure for overdenture retention.
For additional information, please see page 11 - Indications for use
Product codes
DZE
Device Description
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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
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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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 1997
William F. Zingheim, DDS Opti-Max Corporation 6281 Oak Bay Road Port Ludlow, Washington 98365
K972769 Re : Opti-Max Angled Crown Post for Externally-Trade Name: Hexed Implants Requlatory Class: III Product Code: DZE Dated: July 11, 1997 Received: July 24, 1997
Dear Dr. Zingheim:
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 aqainst 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. ਬੈ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 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
1
Page 2 - Dr. Zingheim
through 542 of the Act for devices under the Electronic enrough Sin or eno ontrol 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.gov/cdrh/dsmamain.html".
Sincerely yours,
Patricia Cavanaugh
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
.Enclosure
2
To: Renita Hoord
Page / of /
510(k) Number (if known): _ K 97 - 2769
UCLED CROWN Device Name: Indications For Use:
The Opti-Max angled crown post for externally-hexed implants is intended to be used as an abutment for a cast crown, to be retained by cementation. The metal for this cast crown is to be composed of a computible formulation when in contact with Ti6A4V. If light retention is desired by the cinician zinc-oxide cement can be used, if stronger retention is desired, carboxylate cements of an be used. The cast crown seated on this crown post may be single and free-sanding, part of fixed bridgework, or connected to a bar structure for overdenture retention .
For additional information, please see page 11 - Indications
for use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
pha 27.109
OR
Over-The-Cour
Over-The-Counter Use
(Optional Formal 1-2-96)