(47 days)
Zimmer Dental 3.5mm Hex-Lock Abutment (cat. No. HLA3/3), Zimmer Dental Tapered Abutment (cat. No. TAC2)
Not Found
No
The summary describes a physical dental abutment made of titanium alloy and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as a titanium alloy post used in dental restorations, which is a structural component and not therapeutic in nature. Its function is mechanical support.
No
Explanation: The device is an abutment for dental restorations, which is a prosthetic component, not a device used to diagnose a medical condition. Its intended use describes its function in screw-retained restorations, not in identifying a disease or condition.
No
The device description clearly states it is a "titanium alloy post with a tapered cone," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "multiple unit screw retained restorations" in a dental context. This describes a device used in vivo (within the body) for a restorative procedure.
- Device Description: The description details a "titanium alloy post with a tapered cone" used in "multi unit configurations with a screw retained bridge threaded directly into them." This is a physical implant component.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with biological specimens for diagnostic purposes.
Therefore, the Zimmer Dental One Piece Tapered Abutment is a dental implant component used in a surgical and restorative procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Zimmer Dental Tapered Abutmen is used for screw retained dentures, screw-retained partial dentures and bar Overdenture restorations.
The Zimmer Dental One Piece Tapered Abutment is intended for use in multiple unit screw retained restorations.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Tapered Abutment is a titanium alloy post with a tapered cone. The abutments are utilized in multi unit configurations with a screw retained bridge threaded directly into them. The new Abutment features a .75mm cuff height.
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): 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 Dental 3.5mm Hex-Lock Abutment (cat. No. HLA3/3), Zimmer Dental Tapered Abutment (cat. No. TAC2)
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
§ 872.3630 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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| 510k No | |||
|---|---|---|---|
| Page No. | ਾ ਨੇ | l | |
| 10 |
ecial 510(k): Device Modification MARKET NOTIFICATION 510(k)
. 7
510(k) SUMMARY (21CFR807.92(a))
-
- Submitter's Information:
| Name: | Zimmer Dental Inc. |
|---|---|
| Address: | 1900 Aston Ave. |
| Carlsbad, CA 92008 | |
| Phone: | 760-929-4300 |
| Contact: | William Fisher |
| Date Prepared: | March 29, 2006 |
-
- Device Name: Zimmer Dental Tapered Abutment
Device Classification Name: Endosseous Dental Implant Abutment
- Device Name: Zimmer Dental Tapered Abutment
-
- Predicate Device: Zimmer Dental 3.5mm Hex-Lock Abutment (cat. No. HLA3/3) Zimmer Dental Tapered Abutment (cat. No. TAC2)
-
- Device Description:
The Tapered Abutment is a titanium alloy post with a tapered cone. The abutments are utilized in multi unit configurations with a screw retained bridge threaded directly into them. The new Abutment features a .75mm cuff height.
-
- Intended Use:
The Zimmer Dental Tapered Abutmen is used for screw retained dentures, screw-retained partial dentures and bar Overdenture restorations.
- Intended Use:
-
- Device Comparison:
The new Tapered abutments and the predicate Tapered abutment have an identical intended use and design with the only difference being the height of the cuff (.75mm vs. 2.0mm). The new Tapered abutment differs from the predicate Hex-Lock abutment by being intended for use in multiple unit screw retained restorations, whereas the predicate device may also be used as a single unit restoration.
- 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 is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 7 2006
Mr. William Fisher Regulatory Affairs Associate Zimmer Dental, Incorporated 1900 Aston Avenue Carlsbad, California 92008
Re: K060880
Trade/Device Name: Zimmer Dental Tapered Abutment Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: April 26, 2006 Received: April 27, 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 (OS) 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
KO60880 510(k) Number (if known):
Device Name: Zimmer Dental Tapered Abutment
Indications For Use:
The Zimmer Dental One Piece Tapered Abutment is intended for use in multiple unit screw retained restorations.
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)
Sheer Russer
Sign-Of
of Anssthesiology, General Hospital,
n Control, Dental Devices
1060580
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