(43 days)
Not Found
No
The device description and performance studies section do not mention any AI or ML components or capabilities. The device is a physical object used for soft tissue formation.
Yes
The device is described as assisting in the forming of soft tissue during healing. Healing and assisting in biological processes classify a device as therapeutic.
No
Explanation: The device description states its purpose is to "assist in the forming of the soft tissue during healing before a final restoration is placed" and describes how it is used as a physical component in a dental procedure. There is no mention of it being used to detect, diagnose, or monitor any condition or disease.
No
The device description clearly describes a physical, implantable device made of material that is threaded onto an implant and remains in the mouth. It mentions physical characteristics like size, color, and etching, which are all hardware attributes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist in the forming of the soft tissue during healing before a final restoration is placed." This is a direct interaction with the patient's body (in vivo) to facilitate a physical healing process.
- Device Description: The description details how the device is placed on an implant in the mouth and remains there to shape soft tissue. This is a physical, non-diagnostic function.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the body (like blood, urine, tissue) or to provide information about a patient's health status or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This healing collar does not perform any of these functions.
N/A
Intended Use / Indications for Use
The Healing Collar is used to assist in the forming of the soft tissue during healing before a final restoration is placed. The Healing Collar is for single use only.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The healing collar is designed to form the soft tissue during the healing period before a final restoration is placed. The device is threaded onto the implant immediately after implant placement in a one-stage protocol. In a two-stage protocol, the healing collar is placed on the implant following the bone healing period. The soft tissue is sutured around the healing collar and the device remains in the mouth until the soft tissue fully develops.
Depending on the needs of the patient, various healing collar sizes are available to interface with the implant and also to properly form the soft tissue. Healing collars are offered with three distinct implant platform diameters to accommodate for the different implant platform sizes. They are also available in differing cuff heights and emergence profile diameters to assist in forming the soft tissue. Because of the various sizes available, certain features are being incorporated into the design to assist in identifying the healing collars visually:
1.) The bottom half of the healing collar will be colored according to the shade that defines its respective implant platform size.
2.) The top face will be etched with all size parameters related to the use of the healing collar: implant platform diameter, emergence profile diameter, 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)
Non-Clinical Testing: Non-clinical testing was not performed. The Healing Collars are not load bearing components, they are placed out of occlusion and experience minimal mechanical forces. Since the design and function of the Anodized Healing Collars is equivalent to the existing Healing Collars, the mechanical properties of the material are sufficient for the function of the part. In addition, because the two part families are dimensionally identical, the Anodized Healing Collars will interface with mating components in the same manner as the current Healing Collars. Therefore, any loading conditions will remain the same and the Anodized Healing Collars do not present a new worst case when compared to the Healing Collars. As a result, mechanical testing is not necessary.
Clinical Testing: No clinical testing was performed. Non-clinical testing was used to support the decision of safety and effectiveness.
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
Image /page/0/Picture/0 description: The image shows the logo for Zimmer Dental. The logo consists of a stylized letter "Z" inside of a circle, with the word "zimmer" written below it in a sans-serif font. Below the word "zimmer" is the word "dental" in a smaller font size.
| Zimmer Dental | |
|---|---|
| --------------- | -- |
111852 510k No.:
1900 Aston Avenue Carlsbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)
A5-1 Page No .:
AUG 1 1 2011
ﮩﺴ
pecial 510(k): Device Modification -MARKET NOTIFICATION 510(k) 510(k) SUMMARY (21CFR807.92(a))
Anodized Healing Collar
872.3630 NHA
-
- Submitter's Information:
| Name: | Zimmer Dental Inc. |
|---|---|
| Address: | 1900 Aston Ave. Carlsbad, CA 92008 |
| Phone: | 760-929-4300 |
| Contact: | Melissa Burbage |
| Date Prepared: | June 28, 2011 |
-
- Device Name:
| Trade Name: |
|---|
| Regulation Number: |
| Classification Code: |
- Predicate Device(s): Trade Name:
510(k) No: Requlation Number: Classification Code:
Paragon Implant System (now known as Tapered Screw-Vent System) K953101 872.3640 DZE
Device Description: র্বা
The healing collar is designed to form the soft tissue during the healing period before a final restoration is placed. The device is threaded onto the implant immediately after implant placement in a one-stage profocol. In a two-stage protocol, the healing collar is placed on the implant following the bone healing period. The soft tissue is sutured around the healing collar and the device remains in the mouth until the soft tissue fully develops.
Depending on the needs of the patient, various healing collar sizes are available to interface with the implant and also to properly form the soft tissue. Healing collars are offered with three distinct implant platform diameters to accommodate for the different implant platform sizes. They are also available in differing cuff heights and emergence profile diameters to assist in forming the soft tissue. Because of the various
1
510(k) No. A5-2 Page No.
sizes available, certain features are being incorporated into the design to assist in identifying the healing collars visually:
The bottom half of the healing collar will be colored according to 1.) the shade that defines its respective implant platform size.
The top face will be etched with all size parameters related to the 2.) use of the healing collar: implant platform diameter, emergence profile diameter, cuff height.
Indications for Use: 5.
The Healing Collar is used to assist in the forming of the soft tissue during healing before a final restoration is placed. The Healing Collar is for single use only.
Device Comparison: 6.
The new device is equivalent in design with Healing Collar Predicate. The new device has an added manufacturing process of anodization to allow for color coding. The device dimensions specifications, material, implant interface, and function in the system remains the same as the Healing Collar Predicate Device.
7. Non-Clinical Testing:
Non-clinical testing was not performed. The Healing Collars are not load bearing components, they are placed out of occlusion and experience minimal mechanical forces. Since the design and function of the Anodized Healing Collars is equivalent to the existing Healing Collars, the mechanical properties of the material are sufficient for the function of the part. In addition, because the two part families are dimensionally identical, the Anodized Healing Collars will interface with mating components in the same manner as the current Healing Collars. Therefore, any loading conditions will remain the same and the Anodized Healing Collars do not present a new worst case when compared to the Healing Collars. As a result, mechanical testing is not necessary.
Clinical Testing 8.
No clinical testing was performed. Non-clinical testing was used to support the decision of safety and effectiveness.
-
- Conclusion
2
| 510(k) No. | |
|---|---|
| Page No. | A5-2 |
Based on our analysis, the device is substantially equivalent to the Baoou off our analyders the new device is as safe and effective for its intended use and performs as well the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Melissa Burbage Manager, Regulatory Affairs Zimmer Dental, Incorporated 1900 Aston Avenue Carlsbad, California 92008-7308
AUG 1 1 2011
Re: K111852
Trade/Device Name: Anodized Healing Collar Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 1. 2011 Received: August 2, 2011
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.
4
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/ucm 1 15809.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 vours.
hn for
Anthony D. Watson, B.S., M.S., M.B.A. 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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Image /page/5/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 is the word "zimmer" in a bold, sans-serif font, with a line underneath it. Below "zimmer" is the word "dental" in a smaller, non-bold font.
Indications for Use **
111828 510(k) Number (if known):
Device Name: Anodized Healing Collar
Indications For Use:
ﺔ ﺑﺎﻟﻘﺎﺑﺔ
The Healing Collar is used to assist in the forming of the soft tissue during healing before a final restoration is placed. The Healing Collar is for single use only.
× 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)
Swsa Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
1411852 510(k) Number: