(22 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a dental abutment, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an abutment, which is a component of a dental implant used for supporting a prosthesis. Its function is structural (to hold a cemented prosthesis), not to treat or cure a disease or medical condition.
No
This device is described as an abutment used for a cemented prosthesis, which is a restorative component rather than a tool for diagnosis.
No
The device description clearly states it is a titanium alloy post, which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The description of the Zimmer Dental Hex-Lock Prepared Straight and Angled Abutments clearly indicates they are physical components used in dental prosthetics, specifically as abutments for cemented restorations. They are implanted devices, not devices used to test biological samples.
The information provided focuses on the physical characteristics, intended use in dental procedures, and materials of the abutments, which are all consistent with a medical device used in surgery, not an IVD.
N/A
Intended Use / Indications for Use
The Zimmer Dental Hex-Lock Prepared Straight Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. The Zimmer Dental Hex-Lock Prepared Angled Abutment is used as a terminal or intermediate abutment for a cemented prosthesis where the angle needs to be offset by 17°. Either 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 'Prepared' Abutment is a titanium alloy post with a tapered cone, predefined margin and varying cuff heights. The abutment engages the internal hex of the implant and is secured with a separate retaining screw. The cone of the abutment is 5.5mm in height, with 8° of taper (4° per side). The height of the cuff is lower on the buccal aspect, higher on the lingual. A vertical groove is located on the lingual aspect of the cone.
The 'Prepared' Angled Abutment is a titanium alloy post with the cone offset by 17°, a predefined margin and varying cuff heights. The abutment engages the internal hex of the implant and is secured with a separate retaining screw. The cone of the abutment is 5.5mm in height, with 8° of taper (4° per side). The height of the cuff is lower on the buccal aspect, higher on the lingual. A vertical groove is located on the lingual aspect of the cone.
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.
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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Image /page/0/Picture/0 description: The image shows a logo for Zimmer Dental. The logo features a stylized letter "Z" inside a circle above the word "zimmer" in a lowercase, sans-serif font. Below "zimmer" is the word "dental" in a smaller, lighter font.
Zimmer Dental
1900 Aston Avenue Carlsbad, CA 92008 510k No .: K 652600
Page No .: 12.15-1
OCT 1 3 2005
al 510(k): Device Modification ARKET NOTIFICATION 510(k)
510(k) SUMMARY (21CFR807.92(a))
- Submitter's Information: 1.
| Name: | Zimmer Dental Inc. |
|---|---|
| Address: | 1900 Aston Ave. |
| Carlsbad, CA 92008 | |
| Phone: | 760-929-4300 |
| Contact: | Erin L. McVey |
| Date Prepared: | September 19, 2005 |
-
- Device Name *: Zimmer Dental Prepared Hex-Lock Straight Abutment Zimmer Dental Prepared Hex-Lock Angled Abutment
- Device trade name not available at time of submission.
Device Classification Name: Endosseous Dental Implant Abutment
-
- Predicate Device: Zimmer Dental 3.5mm Hex-Lock Abutment (cat. No. HLA3/3)
-
- Device Description:
The 'Prepared' Abutment is a titanium alloy post with a tapered cone, predefined margin and varying cuff heights. The abutment engages the internal hex of the implant and is secured with a separate retaining screw. The cone of the abutment is 5.5mm in height, with 8° of taper (4° per side). The height of the cuff is lower on the buccal aspect, higher on the lingual. A vertical groove is located on the lingual aspect of the cone.
The 'Prepared' Angled Abutment is a titanium alloy post with the cone offset by 17°, a predefined margin and varying cuff heights. The abutment engages the internal hex of the implant and is secured with a separate retaining screw. The cone of the abutment is 5.5mm in height, with 8° of taper (4° per side). The height of the cuff is lower on the buccal aspect, higher on the lingual. A vertical groove is located on the lingual aspect of the cone.
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12.15-2
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- Intended Use:
The Zimmer Dental Hex-Lock Prepared Abutment, Straight is used as a terminal or intermediate abutment for a cemented prosthesis. The Zimmer Dental Hex-Lock Prepared Abutment. Angled is used as a terminal or intermediate abutment. for a cemented prosthesis where the angle needs to be offset by 17°. Either abutment can be used for a single or multiple-unit restoration.
- Intended Use:
-
- Device Comparison:
The new straight & angled abutments and the predicate abutment have an identical internal hex friction-fit implant interface. The new device will be affixed to the implant in the same manner as the predicate. The new straight abutment will use the same screw as the predicate. The device modification is a dimensional change. The materials, general structure, and function in the endosseous implant system remains the same as the predicate device.
- Device Comparison:
The new abutment differs from the predicate by providing a prepared margin and cone shape. The end user can make additional modifications if desired, but the new abutment can be used "as is." The taper on the cone of the new abutment is 4 degrees. The new abutment also adds two coronal grooves for crown retention. The cone of the new abutment has a non-circular cross section for anti-rotation compared to a flat side on the predicate design. A vertical groove has been added on the linqual aspect for additional anti-rotation. This feature was added to create better interaction with mating plastic caps. The shape of the emergence profile on the new abutment varies from the predicate. The new abutment has a contoured cuff that rises from the implant platform and flares out to a wider emergence profile diameter.
The predicate is an un-prepared abutment that the dental lab contours specifically for the patient's needs. The predicate abutment has no predefined margin or cone shape. The end user grinds the titanium to define the desired margin and determine the cone geometry. The predicate abutment features straight walls. The end user defines the angle of the cone in their preparation. The predicate's circular grooves are height markings at 1mm intervals to aid in marking the abutment for preparation. The grooves on the predicate are typically removed in the preparation process and are not designed for crown retention. In addition, the predicate design rises straight off the implant platform with no flare.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" written around it. Inside the circle is a symbol that resembles three stylized human profiles facing to the right, with flowing lines connecting them.
OCT 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Erin L. McVey Regulatory Affairs Specialist Zimmer Dental Incorporated 1900 Aston Avenue Carlsbad, California 92008-7308
Re: K052600
Trade/Device Name: ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED) Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 20, 2005 Received: September 21, 2005
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 (1 wr 1, it a 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.
3
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. or the For of arry 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 m 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), rl gase 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.
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
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Indications for Use
510(k) Number (if known): K052600
Device Name: Zimmer Dental Hex-Lock Prepared Abutment (straight & angled)
Indications For Use:
The Zimmer Dental Hex-Lock Prepared Straight Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. The Zimmer Dental Hex-Lock Prepared Angled Abutment is used as a terminal or intermediate abutment for a cemented prosthesis where the angle needs to be offset by 17°. Either 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 Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental De
510(k) Number: K052106
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