(231 days)
Not Found
No
The summary describes a patient-specific dental abutment manufactured based on customer needs and modifications, but there is no mention of AI or ML being used in the design, manufacturing, or modification process. The performance studies focus on reverse engineering, compatibility analysis, and mechanical fatigue testing, which are traditional engineering methods.
Yes
The device is a dental implant abutment, which is specifically designed to support dental prostheses, thereby restoring function and form to the patient's dentition. This falls under the definition of a therapeutic device as it treats a medical condition (missing teeth).
No.
The document describes a dental implant abutment, which is a prosthetic component designed to support dental restorations, not to diagnose a condition.
No
The device description explicitly states the abutment is composed of Titanium alloy and is secured with a separate Titanium alloy screw, indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a dental implant abutment, which is a component used in dental surgery to connect a dental implant to a prosthetic tooth. It is a physical device implanted in the body.
- Intended Use: The intended use is for supporting cement-retained prostheses in the mouth, directly interacting with the patient's anatomy.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, providing diagnostic information based on laboratory tests, or any of the typical characteristics of an IVD.
The device is a medical device, specifically a dental implant component, but it falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Zimmer Zfx Abutment for Nobel Replace Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with NobelReplace, Replace Select and NobelSpeedy Replace implants with a Narrow Platform (NP) Ø 3.5 mm, Regular Platform (RP) Ø 4.3 mm, Wide Platform (WP) Ø 5.0 mm or 6.0 Platform (6.0) Ø 6.0 mm.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The purpose of a Patient-Specific abutment is to satisfy customer needs that are otherwise difficult to meet with off-the-shelf abutments. They can be manufactured in multiple sizes, shapes, and angles. They frequently incorporate the modifications typically done at a dental laboratory or "chair-size" by a dentist. Traditional methodologies require the customer (dentist/laboratory technician) to begin with a "stock" abutment and use manual subtractive techniques to remove material from this original "stock" design. However, the Patient-Specific abutment will incorporate these same modifications desired by the customer (dentist/laboratory technician) at the time of fabrication at the manufacturing facility.
The Zimmer Zfx Abutment for NobelReplace Implant System is a dental implant abutment with a fixed competitor compatible interface. It is designed for use with NobelReplace endosseous dental implants to support single or multi tooth restorations. The abutment-implant interface is an internal tri-lobe. The engineering drawings list ranges in areas (attributes) of the abutment that may be modified depending upon patient-specific needs.
The abutment is composed of Titanium alloy (Ti6AI4V) and it is secured to the implant with a separate Titanium alloy screw for retention.
The new abutment will be available with a choice of 3.5mm, 4.3mm, 5.0mm, and 6.0mm platform diameters. The maximum abutment anqulation will be 20°. The new abutment will interface with Nobel Replace implants with an internal tri-lobe connection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
all regions of the mouth, including the posterior
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)
Non-clinical test data was used to support the decision of substantial equivalence. This consisted of reverse engineering, compatibility analysis and mechanical fatigue testing. The NobelReplace interface was reverse engineered based on actual measurements taken off NobelReplace implants, abutments and retaining screws in order to assure that the Zimmer Zfx Abutment for NobelReplace Implant System is compatible with NobelReplace Implants with tri-lobe connection. Dimensional specifications were developed for the Zimmer fabricated components based on the reverse engineering results. A tolerance analysis as well as a rotational analysis was conducted to illustrate the nature of fit between the Zimmer fabricated parts and the OEM implant. To verify the compatibility of the Zimmer device to the OEM device, fatigue testing was completed using Zimmer fabricated abutments assembled to OEM implants in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments. The results were compared to fatigue testing data of the NobelReplace predicate device and demonstrated that the proposed device is substantially equivalent to the predicate device. Based on the reverse engineering process, as well as verification of the final connection dimensions and tolerances, the Zimmer Zfx Abutment for NobelReplace Implant System can be deemed compatible with the NobelReplace tri-lobe implant interface.
In addition, the Zimmer Zfx Abutment for Nobel Replace Implant System will be sold non-sterile and will be sterilized by the end user. The sterilization procedures listed in the instructions-for-use were validated to provide a minimum sterility assurance level of 10-6.
No clinical testing was performed. Non-clinical testing was used to support the decision of substantial equivalence.
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.)
0
Zimmer Zfx Abutment for NobelReplace Implant System Zimmer Dental
1900 Aston Avenue
Carlsbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)
510k No.: K120873
A5-1
NOV
్రెస
8 2012
Page No.:
Traditional 510(k) PRE-MARKET NOTIFICATION 510(k)
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: | Melissa Burbage |
Date Prepared: November 1, 2012
- Device Name:
| Trade Name: | Zimmer Zfx Abutment for NobelReplace Implant System |
|---|---|
| Regulation Number: · | 872.3630 |
| Classification Code: | NHA |
| Device Classification Name: Endosseous Dental Implant Abutment |
3. Predicate Device(s):
510(k) Number:
Regulation Number:
Classification Code:
Predicate Device No. 1 Trade Name:
Zimmer Patient-Specific Abutment, Internal Hex, Titanium K071439 872.3630 NHA Device Classification Name: Endosseous Dental Implant Abutment
Predicate Device No. 2 Trade Name: 510(k) Number: Regulation Number: Classification Code: NHA
NobelProcera Ti Abutment K091756 872.3630
Device Classification Name: Endosseous Dental Implant Abutment
| Predicate Device No. 3 | |
|---|---|
| Trade Name: | Replace TiUnite Endosseous Implant |
| 510(k) Number: | K023113 |
| Regulation Number: | 872.3640 |
| Classification Code: | DZE |
| Device Classification Name: | Implant, Endosseous, Root-form |
1
| 510(k) No. | |
|---|---|
| Page No. | A5-2 |
4. Device Description:
The purpose of a Patient-Specific abutment is to satisfy customer needs that are otherwise difficult to meet with off-the-shelf abutments. They can be manufactured in multiple sizes, shapes, and angles. They frequently incorporate the modifications typically done at a dental laboratory or "chair-size" by a dentist. Traditional methodologies require the customer (dentist/laboratory technician) to begin with a "stock" abutment and use manual subtractive techniques to remove material from this original "stock" design. However, the Patient-Specific abutment will incorporate these same modifications desired by the customer (dentist/laboratory technician) at the time of fabrication at the manufacturing facility.
5
The Zimmer Zfx Abutment for NobelReplace Implant System is a dental implant abutment with a fixed competitor compatible interface. It is designed for use with NobelReplace endosseous dental implants to support single or multi tooth restorations. The abutment-implant interface is an internal tri-lobe. The engineering drawings list ranges in areas (attributes) of the abutment that may be modified depending upon patient-specific needs.
The abutment is composed of Titanium alloy (Ti6AI4V) and it is secured to the implant with a separate Titanium allov screw for retention.
The new abutment will be available with a choice of 3.5mm, 4.3mm, 5.0mm, and 6.0mm platform diameters. The maximum abutment anqulation will be 20°. The new abutment will interface with Nobel Replace implants with an internal tri-lobe connection.
ട. Indications for Use:
The Zimmer Zfx Abutment for Nobel Replace Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with NobelReplace, Replace Select and NobelSpeedy Replace implants with a Narrow Platform (NP) Ø 3.5 mm, Regular Platform (RP) Ø 4.3 mm, Wide Platform (WP) Ø 5.0 mm or 6.0 Platform (6.0) Ø 6.0 mm.
6. Device Comparison:
The new device is substantially equivalent to the predicate relative to material and general design features. The function in the endosseous implant system remains the same as the predicate devices. It is fabricated from Titanium alloy and utilizes the tri-lobe implant/abutment interface. which is similar in size and shape (for a given platform diameter) to the predicate device. The new device will be affixed to the implant by a retaining screw, the same manner as the predicate. Mechanical fatigue testing has demonstrated that all sizes of the implant/abutment assembly are mechanically suitable for placement in all regions of the mouth, including the posterior.
2
510(k) No.
Page No.
A5-3
7. Technological Characteristics
| Feature | New Device
Zimmer Zfx
Abutment for
NobelReplace
Implant System | Predicate 1
Zimmer Titanium
PSA | Predicate 2
Nobel Procera
Abutment | Predicate 3
NobelReplace
NP Abutment |
|------------------------------------|----------------------------------------------------------------------------|---------------------------------------|------------------------------------------|--------------------------------------------|
| Material | Titanium 6Al-4V | Titanium 6Al-4V | Titanium or Titanium
6Al-4V | Titanium or
Titanium 6Al-4V |
| Implant
Interface | Internal Tri-lobe | Internal Hex | Internal Tri-lobe | Internal Tri-lobe |
| Emergence | Contoured, curved | Contoured,
curved | Contoured, curved | Contoured,
curved |
| Margin | Pre-machined | Pre-machined | Pre-machined | Pre-machined |
| Platform
Diameter | 3.5mm, 4.3mm,
5.0mm, 6.0mm | 3.5mm, 4.5mm,
5.7mm | 3.5mm, 4.3mm,
5.0mm, 6.0mm | 3.5mm |
| Cuff Width | 3.5mm-12mm | 3.5mm-8.0mm | 3.5mm-16mm | 4.2mm |
| Cone and
Overall Cone
Height | 3.0-11.5 Cone
3.5-12.0 Overall | 3mm-12mm | 15mm overall
abutment height | 6.5-7.5mm |
| Maximum
Angulation | 20° | 30° | 25° | 15° |
| Retaining
Screw | New device | Cat. No. MHLAS | Cat No 36818 &
29475 | Cat No 36818 |
8. Non-Clinical Testing:
Non-clinical test data was used to support the decision of substantial equivalence. This consisted of reverse engineering, compatibility analysis and mechanical fatigue testing. The NobelReplace interface was reverse engineered based on actual measurements taken off NobelReplace implants, abutments and retaining screws in order to assure that the Zimmer Zfx Abutment for NobelReplace Implant System is compatible with NobelReplace Implants with tri-lobe connection. Dimensional specifications were developed for the Zimmer fabricated components based on the reverse engineering results. A tolerance analysis as well as a rotational analysis was conducted to illustrate the nature of fit between the Zimmer fabricated parts and the OEM implant. To verify the compatibility of the Zimmer device to the OEM device, fatigue testing was completed using Zimmer fabricated abutments assembled to OEM implants in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments. The results were compared to fatigue testing data of the NobelReplace predicate device and demonstrated that the proposed device is substantially equivalent to the predicate device. Based on the reverse engineering process, as well as verification of the final connection dimensions and tolerances, the
10(k) No
3
Zimmer Zfx Abutment for NobelReplace Implant System
| 510(k) No. | |
|---|---|
| Page No. | A5-3 |
Zimmer Zfx Abutment for NobelReplace Implant System can be deemed compatible with the NobelReplace tri-lobe implant interface.
In addition, the Zimmer Zfx Abutment for Nobel Replace Implant System will be sold non-sterile and will be sterilized by the end user. The sterilization procedures listed in the instructions-for-use were validated to provide a minimum sterility assurance level of 10-6.
റ്റ. Clinical Testing
No clinical testing was performed. Non-clinical testing was used to support the decision of substantial equivalence.
10. Conclusion
Based on our analysis, the device is substantially equivalent to the predicate.
し
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue
Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Public Health Service
Letter Date: November 8, 2012
Zimmer Dental Incorporated Ms. Melissa Burbage Associate Director Regulatory Affairs 1900 Aston Avenue Carlsbad, California 92008
Re: K120873
Trade/Device Name: Zimmer Zfx Abutment for Nobel Replace Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 1, 2012 Received: November 2, 2012
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
5
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kwame O.
Ulmer
Digitally signed by Kwame O. Ulmer
DN: c=US, o=U.S. Government, ou=HHS
ou=FDA, ou=People, cn=Kwame O.
Ulmer,
0.9.2342.19200300.100.1.1=1300183618
Date: 2012.11.08 15:54:26 -05'00'
for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and
Dental Devices
Office of Device Evaluation
. Center for Devices and
Radiological Health
Enclosure
6
Response to K120873 Page 1 of 1
Attachment 1
Z
immer
Indications for Use
510(k) Number (if known):
Device Name: Zimmer Zfx Abutment for Nobel Replace Implant System
Indications For Use:
The Zimmer Zfx Abutment for Nobel Replace Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with NobelReplace, Replace Select and NobelSpeedy abutinent our be access with a Narrow Platform (NP) Ø 3.5 mm, Regular Platform (RP) Ø 4.3 mm, Wide Platform (WP) Ø 5.0 mm or 6.0 Platform (6.0) Ø 6.0 mm.
× 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)
Snorase
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anesthesion gyl
Infection Control, Dental Devices 7
infection
510(k) Number: K120873