(83 days)
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No
The summary describes a physical dental abutment and its components, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is described as a temporary abutment for dental prostheses, which is a structural component for a medical device (a prosthesis), not a device itself designed to treat or alleviate a disease or condition.
No
Explanation: The device is a temporary abutment for dental implants, used to support provisional prostheses. Its function is mechanical support, not diagnosis or detection of a disease or condition. The "Intended Use" section describes its role in dental restoration, not diagnosis.
No
The device description clearly states it consists of physical components made of titanium alloy (abutment cylinder and retaining screw), which are hardware.
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 and Intended Use: The provided information clearly describes a dental implant component (a temporary abutment) used within the mouth to support a provisional prosthesis. It is a physical device implanted or attached to the body, not a test performed on a sample outside the body.
The description and intended use are consistent with a Class II medical device used in dentistry.
N/A
Intended Use / Indications for Use
The statements of intended use are identical with the exception that the duration of Temporary Abutment use is limited. Temporary Abutments are intended to be used in the same manner as their permanent counterpart except that the former are used to support temporary (provisional) restorations.
A Temporary Abutment is indicated for use for a maximum of six weeks as an abutment for cemented provisional prostheses. This abutment can be used for single tooth provisional restorations or splinted to other abutments for multi-unit provisional restorations. Single use.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The Spline Dental Implant System - Temporary Abutment will consist of a titanium alloy abutment cylinder with a separate titanium alloy retaining screw. A Temporary Abutment will attach.directly to the Spline implant with the retaining screw but does not engage the tines. It will be available in three different cuff diameters at the abutment/implant interface: 3.25mm, 4.0mm and 5.0mm. Abutments will also be available with straight wall or stepped cuffs with either a straight or a tapered retentive wall.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench top testing demonstrate the substantial equivalence of the Temporary Abutment to the predicate device.
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.
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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
510(K) SUMMARY
Pursuant to 513(i) of the Federal Food, Drug, and Cosmetic Act, as Amended,
| Company Name: | Sulzer Calcitek Inc. |
|---|---|
| Address: | 2320 Faraday Avenue, Carlsbad, CA 92008 |
| Telephone Number: | (760) 431-9515 |
| Registration Number: | 2023141 |
| Contact Person: | Foster Boop |
| Date Summary Prepared: | June 30, 1998 |
| Classification Name: | Implant, Endosseous (76DZE) |
| Common/Usual Name: | Temporary Prosthetic Component |
| Device Trade Name: | Spline Dental Implant System - Temporary Abutment |
The primary device used for comparison purposes in this summary is the Spline Dental Implant System - Fixed Abutment
1. Intended Use:
The statements of intended use are identical with the exception that the duration of Temporary Abutment use is limited. Temporary Abutments are intended to be used in the same manner as their permanent counterpart except that the former are used to support temporary (provisional) restorations.
. 2. Description:
The Spline Dental Implant System - Temporary Abutment will consist of a titanium alloy abutment cylinder with a separate titanium alloy retaining screw. A Temporary Abutment will attach.directly to the Spline implant with the retaining screw but does not engage the tines. It will be available in three different cuff diameters at the abutment/implant interface: 3.25mm, 4.0mm and 5.0mm. Abutments will also be available with straight wall or stepped cuffs with either a straight or a tapered retentive wall.
3. Technological Characteristics:
The Temporary Abutments have the same technological characteristics as the predicate device.
4. Performance Data:
Bench top testing demonstrate the substantial equivalence of the Temporary Abutment to the predicate device.
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5. Comparison Analysis :
The overall design of the Temporary Abutment is identical to the predicate device. :
| SUMMARY OF COMPARISON | ||
|---|---|---|
| Feature | Temporary Abutment | Predicate Device |
| Available Diameters | 3.25mm, 4.0mm & 5.0mm | 3.25mm, 4.0mm & 5.0mm |
| Material | Titanium alloy | Titanium alloy |
| Manufacturing site | Sulzer Calcitek, Carlsbad, CA. | Sulzer Calcitek, Carlsbad, CA. |
| Packaging | tray with tyvek lid | tray with tyvek lid |
| Sterility | Non-sterile | Non-sterile |
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized image of an eagle with three human profiles embedded within its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular fashion around the eagle image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 1998
Mr. Foster Boop Regulatory Affairs Associate Sulzer Calcitek, Incorporated 2320 Faraday Avenue Carlsbad, California 92008
Re : K982305 Spline™ Dental Implant System - Temporary Trade Name: Abutments Regulatory Class: III Product Code: DZE Dated: June 30, 1998 Received: July 1, 1998
Dear Mr. Boop:
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 of the Act. The general controls provisions 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 regulations 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 regulation may result in regulatory 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.
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Page 2 - Mr. Boop
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) 594-4692. 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, 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11
Timothy 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) :
Temporary Abutment Device Name:
Indications For Use:
. a
A Temporary Abutment is indicated for use for a maximum of six weeks as an abutment for cemented provisional prostheses. This abutment can be used for single tooth provisional restorations or splinted to other abutments for multi-unit provisional restorations. Single use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) sover Wago (Division Sign-Off) Division of Dental. Infection Control, and General Hospital, Devices 510(k) Number OR Over-The-Counter Use Prescription Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)