(104 days)
Not Found
Not Found
No
The document describes a physical dental abutment and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The Zimmer® Contour Ceramic Abutment is designed to support dental restorations, not to treat, cure, or prevent disease.
No
The device is an abutment for dental implants, supporting restorations. Its intended use is to mechanically connect the implant to a prosthesis, rather than to diagnose a condition.
No
The device description explicitly states it is composed of zirconia ceramic and titanium alloy, 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 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 Zimmer® Contour Ceramic Abutment is a dental implant component used to support a prosthesis in the mouth. It is a physical device implanted in the body, not a test performed on a sample outside the body.
- Intended Use: The intended use is to support dental restorations, not to diagnose a condition or provide information about a person's health through testing of biological samples.
Therefore, the Zimmer® Contour Ceramic Abutment falls under the category of a dental prosthetic device, not an IVD.
N/A
Intended Use / Indications for Use
The Zimmer® Contour Ceramic Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for a single or multiple-unit implant-supported restoration. The 3.5mm abutment is used in the anterior, cuspid, and premolar regions. The 4.5mm abutment can be used in any region of the mouth.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Zimmer® Contour Ceramic Abutment is an abutment designed for use with endosseous dental implants to support single or multi tooth restorations. The abutment has a contoured emergence profile to create a more esthetic restoration. The abutment features a pre-machined margin to facilitate the restoration process. The abutment portion is composed of zirconia ceramic with a titanium alloy seating ring and separate titanium alloy screw for retention.
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
anterior, cuspid, and premolar regions; any region of the mouth (for 4.5mm abutment)
Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use
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)
Not Found
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.
ASTRATech ZirDesign™ Ceramic Abutment (Cat. No. 24183), Zimmer® Hex-Lock Abutment (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.
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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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§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
0
Image /page/0/Picture/0 description: The image shows the logo for Zimmer Dental. The logo consists of a circle with a stylized letter Z inside it. Below the circle, the word "zimmer" is written in a bold, sans-serif font. Underneath "zimmer", the word "dental" is written in a smaller, lighter font.
| Zimmer Dental | |
|---|---|
| --------------- | -- |
1900 Aston Avenue
Carlsbad, CA 92008 760.929.4300 (ph)
KO61847 510k No .:
A5-1
Page No .:
510(k) SUMMARY (21CFR807.92(a))
OCT 1 2 2006
-
- Submitter's Information:
| Name: | Zimmer Dental Inc. |
|---|---|
| Address: | 1900 Aston Ave. |
| Carlsbad, CA 92008 | |
| Phone: | 760-929-4300 |
| Contact: | Erin L. McVey |
| Date Prepared: | June 29, 2006 |
-
- Device Name: Zimmer® Contour Ceramic Abutment
- Device Classification Name: Endosseous Dental Implant Abutment
-
- Predicate Device(s):
- . ASTRATech ZirDesign™ Ceramic Abutment (Cat. No. 24183)
- Zimmer® Hex-Lock Abutment (Cat. No. HLA3/3) .
- Device Description: 4.
The Zimmer® Contour Ceramic Abutment is an abutment designed for use with endosseous dental implants to support single or multi tooth restorations. The abutment has a contoured emergence profile to create a more esthetic restoration. The abutment features a pre-machined margin to facilitate the restoration process. The abutment portion is composed of zirconia ceramic with a titanium alloy seating ring and separate titanium alloy screw for retention.
-
- Intended Use:
The Zimmer® Contour Ceramic Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for a single or multiple-unit implant-supported restoration. The 3.5mm abutment is used in the anterior, cuspid, and premolar regions. The 4.5mm abutment can be used in any region of the mouth.
- Intended Use:
-
- Device Comparison:
Zimmer Dental Inc. believes the Zimmer® Contour Ceramic Abutment to be substantially equivalent to the predicates. They are equivalent in intended use, design, mechanical strength, and materials.
- Device Comparison:
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged around the eagle in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 2 2006
Mr. William Fisher Zimmer Dental, Incorporated Regulatory Affairs Associate 1900 Aston Avenue Carlsbad, California 92008-7308
Re: K061847
Trade/Device Name: Zimmer® Contour Ceramic Abutment Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 2, 2006 Received: October 3, 2006
Dear Mr. Fisher:
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 - Mr. Fisher
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.
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): _KOOL847
Zimmer® Contour Ceramic Abutment Device Name:
Indications For Use:
The Zimmer® Contour Ceramic Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for a single or multiple-unit implant-supported restoration. The 3.5mm abutment is used in the anterior, cuspid, and premolar regions. The 4.5mm abutment can be used in any region of the mouth.
Prescription Use X (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 Runor
Clon Sian-Off I Trision of Anesthesiology. General Hospital, Intection Control, Dental Device
Number: 2061847
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