(177 days)
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No
The description focuses on the mechanical design and materials of a dental implant abutment and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as an abutment, functioning as an anchor for prosthetic devices attached to dental implants, which is a restorative rather than therapeutic function.
No
The device is described as an abutment, functioning as an anchor for prosthetic devices attached to dental implants. Its purpose is to support fixed or removable bridgework or single tooth replacements, which is a restorative rather than diagnostic function.
No
The device description clearly indicates it is a physical, two-piece titanium alloy abutment with a retaining screw, intended for dental implant procedures. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Removable Cuff Abutments are dental implant components used to anchor prosthetic devices within the mouth (mandible or maxilla). They are physical devices implanted in the body, not used to analyze samples taken from the body.
The device is a medical device, specifically a dental implant component, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Removable Cuff Abutments are screw retained endosseous dental implant abutments and are intended to function as an anchor to which prosthetic devices may be attached using either dental oement or a lingual screw.
They are indicated for use on endosseous implants placed in the mandible or maxilla for support of fixed bridgework, removable bridgework or free standing single tooth replacements.
Product codes
76DZE
Device Description
A Removable Cuff Abutment is a two piece titanium alloy abutment with a separate titanium alloy retaining screw. Each Removable Cuff Abutment is composed of one abutment core body and one removable cuff. Removable Cuff Abutments will be offered as fixed abutments and as pre-angled (15 and 25 degree) abutments for use with both cement and screw retained prosthetics. Abutments will be available in three different diameters at the abutment/implant interface: 3.25mm, 4.0mm and 5.0mm. Flare diameters of cuffs will range from 4.0 to 6.5mm and cuff heights will range from 0.5 mm. A new feature is the addition of a transverse (lingual) screw to some designs. This feature will permit attachment of screw retained prostheses in addition to cement retained prostheses. Removable Cuff Abutments will be packaged with or without the transverse (lingual) screw components.
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
mandible or maxilla
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 demonstrated the equivalence of the Removable Cuff Abutment to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
JUN 16 1999
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The characters appear to be a combination of uppercase and lowercase letters and numbers. The string reads 'Ka8433L'.
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: | December 18, 1998 |
| Classification Name: | Implant, Endosseous (76DZE) |
| Common/Usual Name: | Dental Implant Abutment |
| Device Trade Name: | Removable Cuff Abutment |
The primary devices used for comparison purposes in this summary are Spline™ and Omniloc® Abutments: Fixed, 15 and 25 degree pre-angled.
1. Intended Use:
Intended use of a Removable Cuff Abutment is similar to the intended use of the predicate abutments. They are screw retained abutments for endosseous dental implants and function as anchors to which prosthetic devices, such as single crowns or bridges, are attached to restore a patient's chewing function. A Removable Cuff Abutment can serve as an anchor for cement retained or screw retained prosthetic devices. Predicate abutments can only serve as anchors for cement retained prostheses.
2. Description:
A Removable Cuff Abutment is a two piece titanium alloy abutment with a separate titanium alloy retaining screw. Each Removable Cuff Abutment is composed of one abutment core body and one removable cuff. Removable Cuff Abutments will be offered as fixed abutments and as pre-angled (15 and 25 degree) abutments for use with both cement and screw retained prosthetics. Abutments will be available in three different diameters at the abutment/implant interface: 3.25mm, 4.0mm and 5.0mm. Flare diameters of cuffs will range from 4.0 to 6.5mm and cuff heights will range from 0.5 mm. A new feature is the addition of a transverse (lingual) screw to some designs. This feature will permit attachment of screw retained prostheses in addition to cement retained prostheses. Removable Cuff Abutments will be packaged with or without the transverse (lingual) screw components.
3. Technological Characteristics:
Removable Cuff Abutments have the same technological characteristics as the predicate devices.
Page 1 of 2
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Performance Data: 4.
Bench top testing demonstrated the equivalence of the Removable Cuff Abutment to the predicate devices.
ડ. Comparison Analysis :
The overall design of the Removable Cuff Abutment is similar to the predicate devices.
| SUMMARY OF COMPARISON | ||||
|---|---|---|---|---|
| Feature | Removable Cuff | |||
| Abutment | Predicate Abutments | |||
| Abutment Options | Fixed, 15° and 25° pre-angled | Fixed, 15° and 25° pre-angled | ||
| Available Diameters | 3.25mm, 4.0mm & 5.0mm | 3.25mm, 4.0mm & 5.0mm | ||
| Cuff Flare Diameters | 4.0 to 6.5mm | 4.0 to 6.5mm | ||
| Cuff Heights | 0.5 mm to 5.0mm | 0.5 to 5.0mm | ||
| Transverse (lingual) screw | Yes | No | ||
| 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 |
2
Suzler Calcitek – Removable Cuff Abutment
- For submissions claiming substantial equivalence to a device which has been (i) classified into class III under section 513(b) of the act:
- (1) Which was introduced or delivered for introduction into interstate commerce for commercial distribution before December 1, 1990: and
- (2) For which no final regulation requiring premarket approval has been issued under section 515(b) of the act, a summary of the types of safety and effectiveness problems associated with the type of devices being compared and a citation to the information upon which the summary is based (Class III Summary). The 510(k) submitter shall also certify that a reasonable search of all information known or otherwise available about the class III device and other similar legally marketed devices has been conducted (Class III Certification), as described in Sec. 807.94.
A Class III Certification and Summary is provided on the following pages.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 6 1999
Mr. Foster Boop Regulatory Affairs Specialist Sulzer Calcitek Incorporated 2320 Faraday Avenue Carlsbad, California 92008
Re: K984536 Removable Cuff Abutment Trade Name: Requlatory Class: III Product Code: DZE March 19, 1999 Dated: March 22, 1999 Received:
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 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) 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Mr. Boop
this response to your premarket notification Please note: 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.
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) 594-4692. 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,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
5
510(K) Number (if known):
Device Name:
..
Removable Cuff Abutments
Indications For Use:
Removable Cuff Abutments are screw retained endosseous dental implant abutments and are intended to function as an anchor to which prosthetic devices may be attached using either dental oement or a lingual screw.
They are indicated for use on endosseous implants placed in the mandible or maxilla for support of fixed bridgework, removable bridgework or free standing single tooth replacements.
(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) | |||
| Susan Runser | |||
| (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices | |||
| 510(k) Number | K984536 |