(160 days)
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No
The summary describes a standard dental implant system and does not mention any AI or ML components or functionalities.
No.
The device is a dental implant system used for the attachment of prostheses or bridgework, which is a structural or prosthetic device, not a therapeutic one. It replaces missing teeth rather than treating a disease or condition.
No
Explanation: The device description states it is a dental implant system designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses or as an abutment for fixed or removable bridgework. This indicates a therapeutic or restorative purpose, not a diagnostic one. There is no mention of it being used to identify or determine the presence of a disease or condition.
No
The device description clearly states it is a dental implant system, which is a physical hardware device. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that these are "dental implants" designed for placement within the body (in the jawbone). They are not used to test samples outside the body.
- Intended Use: The intended use is for attaching prostheses or acting as abutments for bridgework or single tooth replacements, all of which are procedures performed directly on the patient's anatomy.
Therefore, based on the provided information, the Calcitek Dental Implant Systems are not IVDs. They are implantable medical devices.
N/A
Intended Use / Indications for Use
"For use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement."
Calcitek Dental Implant Systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. The use of the 5.0mm implant is recommended when the quantity and density of bone would dictate the use of an implant larger than 4.0mm.
Product codes
DZE
Device Description
These Class III dental implants are supplied sterile, ready for placement by a licensed dontist.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
edentulous mandibles or maxillae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed dontist
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
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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)
The primary devices used for comparison purposes in this summary rire Calcitek's existing HA-coated endosseous dental implant systems. All implant systems are manufactured in the same facility located in Carlsbad, California.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
JUN 23 1997
Calcitek HA-Coated Endosseous Dental Implants January 1997
510(k) SUMMARY INFORMATION - RELEASABLE THROUGH ! OI
Summary of Information Concerning Safety and Effectiveness for Purposes of establishing Substantial to a Predicate Device Pursuant to 513(i) of the Federal Food, Drug, and Cosmetic Act, as Amended.
| Company Name: | Calcitek, Inc. |
|---|---|
| Address: | 2320 Faraday Avenue, Carlsbad, CA 92008 |
| Telephone Number: | (619) 431-9515 |
| Registration Number: | 2023141 |
| Contact Person: | Donna K. Howard |
| Date Summary Prepared: | December 1996 |
| Classification Name: | Implant, Endosseous (76DZE) |
|---|---|
| Common/Usual Name: | Dental Implant System |
| Device Trade Name: | Calcitek HA-Coated Endosseous Dental Implant Systems |
The primary devices used for comparison purposes in this summary rire Calcitek's existing HA-coated endosseous dental implant systems. All implant systems are manufactured in the same facility located in Carlsbad, California.
The statements of intended use are identical. I . Intended Use:
"For use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement."
- Description: These Class III dental implants are supplied sterile, ready for 2. placement by a licensed dontist.
- ੜ . Technological Characteristics
Design: There has been no change to the design of these implants.
Materials: The materials used for the dental implants are the same as previously mentioned in the premarket notifications.
510(K) SUMMARY INKUKMATION - Releasable through FOI
092-1 ED.9 328-T
ESTE ! EPOGL
Chargar Carol Tex US: UI US 13350
1
Calcitek HA-Coated Endosseous Dental Implants January 1997
4. Comparison Analysis:
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The overall design of the implants is identical to the predicato devices. The composition of the HA coating has been changed. the crystalline HA content has been enhanced and the content of all non-HA components have been decreased.
510(K) SUMMARY INFORMATION - Releasable through FO1
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2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three faces in profile, overlaid with three horizontal lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 23 1997
Ms. Donna K. Howard Supervisor, Clinical Affairs Sulzer Calcitek Incorporated 2320 Faraday Avenue Carlsbad, California 92008-7216
Re : K970127 Endosseous Dental Implant Trade Name: Regulatory Class: III Product Code: DZE Dated: January 10, 1997 Received: January 14, 1997
Dear Ms. Howard:
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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Howard
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 diaqnostic 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 at (301) 443-6597.
Sincerely yours,
Timothy A. Ulatowski
Timoth A. Ulatowski Director
Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K970127
Device Name: HA coated Endosseous Dental Implant
Indications For Use:
Calcitek Dental Implant Systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. The use of the 5.0mm implant is recommended when the quantity and density of bone would dictate the use of an implant larger than 4.0mm.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | Susan Rapser |
|---|---|
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K972007 |
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use $\mu b$
(Optional Format 1 -2-96)