(120 days)
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Not Found
No
The summary describes a patient-specific abutment manufactured based on individual requirements, but there is no mention of AI or ML being used in the design or manufacturing process.
No.
The "Intended Use" states that the device is a terminal or intermediate abutment for a cemented prosthesis, which is a supportive component for a dental restoration, not a device that directly treats or prevents a disease or condition. While it aids in functional and esthetic restoration, its primary role is structural support rather than therapeutic intervention.
No
The device is described as an abutment for prosthetic devices, not a tool for diagnosing medical conditions.
No
The device description explicitly states it is a "titanium alloy abutment" and is "manufactured," indicating it is a physical 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 tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections.
- Device Description: The Zimmer® Patient Specific Abutment is a physical implant component used within the body to support a dental prosthesis. It is a medical device, but not one that performs diagnostic testing on biological samples.
- Intended Use: The intended use is to provide support for a cemented prosthesis, which is a restorative function, not a diagnostic one.
Therefore, this device falls under the category of a medical device but not specifically an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Zimmer® Patient Specific Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for a single or multiple-unit restoration.
The Zimmer® Patient Specific Abutment, Internal Hex, Titanium is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for a single or multiple-unit restoration.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Zimmer® Patient-Specific Abutment is a titanium alloy abutment for use with endosseous dental implants to provide support for prosthetic devices. The abutment is manufactured using individual patient-specific requirements to create a design that facilitates functional, as well as, esthetic restoration. Ensure the implant size and abutment angulation are appropriate for the occlusal load. Highly angulated abutments should be avoided in the posterior region.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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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.
Zimmer® Hex-Lock Abutment, 3.5mm (cat. No. HLA3/3)
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.
Not Found
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.
0
Image /page/0/Picture/0 description: The image shows the logo for Zimmer Dental. The logo features a stylized letter "Z" inside of a circle. Below the circle is the word "zimmer" in a bold, sans-serif font, with a line underneath it, and the word "dental" in a smaller, sans-serif font below the line.
Zimmer Dental
1900 Aston Avenue Carlsbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)
510k No.:
Page No.: A5-1
I 510(k)
' of '
Traditional 5 PRE-MARKET NOTIF
SEP 2 0 2007
510(k) SUMMARY (21CFR807.92(a))
-
- Submitter's Information:
| Name: | Zimmer Dental Inc. |
|---|---|
| Address: | 1900 Aston Ave. |
| Carlsbad, CA 92008-7308 USA | |
| Phone: | 760-929-4300 |
| Contact: | Erin L. McVey |
| Date Prepared: | September 12, 2007 |
- Device Name*: Patient-Specific Abutment, Internal Hex, Titanium 2.
*Device trade name not available at time of submission.
Device Classification Name: Endosseous Dental Implant Abutment
- Predicate Device: Zimmer® Hex-Lock Abutment, 3.5mm (cat. No. HLA3/3) 3.
- Device Description: 4.
The Zimmer® Patient-Specific Abutment is a titanium alloy abutment for use with endosseous dental implants to provide support for prosthetic devices. The abutment is manufactured using individual patient-specific requirements to create a design that facilitates functional, as well as, esthetic restoration. Ensure the implant size and abutment angulation are appropriate for the occlusal load. Highly angulated abutments should be avoided in the posterior region.
-
ട. Intended Use:
The Zimmer® Patient Specific Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for a single or multiple-unit restoration. -
- Device Comparison:
The new device is substantially equivalent to the predicate relative to material and general design features. In addition, the new device is substantially equivalent to the predicate as evidenced in mechanical testing.
- Device Comparison:
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem is a stylized representation of an eagle or bird-like figure, with three curved lines suggesting wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 0 2007
Ms. Erin L. McVey, RAC(US) Senior Regulatory Affairs Specialist Zimmer Dental, Incorporated 1900 Aston Avenue Carlsbad, California 92008
Re: K071439
Trade/Device Name: Zimmer® Patient-Specific Abutment, Internal Hex, Titanium Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 10, 2007 Received: September 12, 2007
Dear Ms. McVey:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Ms. McVey
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sylvie y. Michaud md.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): `K071439
Zimmer® Patient-Specific Abutment, Internal Hex, Titanium Device Name:
Indications For Use:
The Zimmer® Patient Specific Abutment, Internal Hex, Titanium is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for a single or multiple-unit restoration.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Burns
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K07436
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