(246 days)
ASTRA Tech, ZirDesign™ Ceramic Abutment
None
No
The summary describes a patient-specific ceramic abutment manufactured based on individual patient requirements, but does not mention any AI or ML technology used in the design or manufacturing process.
No
The device is an abutment for dental implants, which supports a prosthetic device. It is not designed to treat a disease or condition therapeutically.
No
Explanation: The device is a "Zimmer Patient Specific Ceramic Abutment" used as an intermediate or terminal abutment for a cemented prosthesis, providing support for prosthetic devices. Its function is to facilitate functional and esthetic restoration, not to diagnose a condition.
No
The device description clearly states it is a "zirconia abutment," which is a physical hardware component.
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 taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Zimmer Patient Specific Ceramic Abutment is a physical component used in dental restorations. It is implanted into the body to support a prosthesis.
- Intended Use: The intended use clearly states it's for supporting cemented prostheses in the mouth. This is a structural and mechanical function, not a diagnostic one.
- Device Description: The description confirms it's a zirconia abutment for use with dental implants.
The information provided describes a medical device used for treatment and restoration, not for diagnosing a condition based on in vitro testing.
N/A
Intended Use / Indications for Use
The Zimmer Patient Specific Ceramic Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for single or multipleunit restorations in anterior and pre-molar regions.
Product codes
NHA
Device Description
The Zimmer® Patient-Specific Ceramic Abutment is a zirconia 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
ASTRA Tech, ZirDesign™ Ceramic Abutment
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.)
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Image /page/0/Picture/0 description: The image shows the logo for Zimmer Dental. The logo consists of a large, stylized letter Z inside of a circle. Below the circle, the word "zimmer" is written in a bold, sans-serif font, and below that, the word "dental" is written in a smaller, lighter font.
Zimmer Dental
510k No.: K080164
Page No .: A5-1
1900 Aston Avenue Carlsbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)
SEP 2 5 2008
Traditional 510(k) PRE-MARKET NOTIFICATION
510(k) SUMMARY (21CFR807.92(a))
- Submitter's Information:
| Name: | Zimmer Dental Inc. |
|---|---|
| Address: | 1900 Aston Ave. |
| Carlsbad, CA 92008-7308 | |
| Phone: | 760-929-4300 |
| Contact: | Melissa Burbage |
| Date Prepared: | September 16, 2008 |
-
- Device Name: Zimmer® Patient-Specific Ceramic Abutment
Device Classification Name: Endosseous Dental Implant Abutment
- Device Name: Zimmer® Patient-Specific Ceramic Abutment
-
Predicate Device: ASTRA Tech, ZirDesign™ Ceramic Abutment 3.
-
- Device Description:
The Zimmer® Patient-Specific Ceramic Abutment is a zirconia 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.
-
- Intended Use:
The Zimmer® Patient Specific 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 restoration in anterior and pre-molar regions.
- Intended Use:
-
- 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:
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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 eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 5 2008
Ms. Melissa Burbage Manager, Regulatory Affairs Zimmer Dental, Incorporated 1900 Aston Avenue Carlsbad, California 92008
Rc: K080164
Trade/Device Name: Zimmer® Patient-Specific Ceramic Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 16, 2008 Received: September 19, 2008
Dear Ms. Burbage:
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. Burbage
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Zimmer® Patient-Specific Ceramic Abutment Device Name:
Indications For Use:
The Zimmer Patient Specific Ceramic Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for single or multipleunit restorations in anterior and pre-molar regions.
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 Rumores
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: Kos0164
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