(191 days)
No
The device description and performance studies focus on the physical properties and intended use of a dental healing cap, with no mention of AI or ML technologies.
No.
The primary purpose of this device is to protect the internal connection of dental abutments and prepare soft tissue for prosthetic procedures, not to treat or cure a disease or condition.
No
Explanation: The device is described as a prosthetic component used for soft tissue healing and protection, not for diagnosis or detection of a condition.
No
The device description clearly states it is a "premanufactured prosthetic component" made of "titanium" and is a "transmucosal extension secured to Nobel Biocare Multiunit Abutments," 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 to protect the internal connection of dental abutments and prepare soft tissue during healing. This is a mechanical function performed directly on the patient's tissue.
- Device Description: The description reinforces the mechanical function of a transmucosal extension for soft tissue healing and protection.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
IVD devices are used to test samples like blood, urine, or tissue to provide diagnostic information. This device is a physical component used in a dental procedure.
N/A
Intended Use / Indications for Use
The Healing Cap Multi-unit Titanium is a premanufactured prosthetic component to be directly connected to the dental abutment during soft tissue healing to protect the internal connection of the abutments and prepare the soft tissue for the prosthetic procedure. Maximum intra-oral use is 180-days.
Product codes
NHA
Device Description
The Healing Cap Multi-unit Titanium is a transmucosal extension secured to Nobel Biocare Multiunit Abutments. It is intended to be used during intra-oral soft tissue healing to protect the internal connection of the MUA Multi-unit Abutments and prepare the soft tissue for the prosthetic procedure (temporary and final restoration). It has a maximum intra-oral use of 180-days.
The Healing Cap Multi-unit titanium portfolio consist of 6 healing cap variants. There are two different caps designs, two heights, and three diameters to accommodate the gingival anatomy and to provide the dentist with options for abutment shoulder visibility and soft tissue retraction.
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)
Summary of Non-Clinical Testing:
Since the subject device does not represent a new worst case, data from the predicate device was leveraged in the following aspects of the 510(k).
- Sterile Device Information - The sterilization method for the subject device is the same as the reference predicate. The sterilization method is Gamma radiation and has been validated in accordance with ANSI/AAMI/ISO 11137. Therefore, no additional testing was required.
- Device Packaging - The packaging for the subject device is the same as the reference predicate. This is a thermoform tray with peel top lid. Therefore, no additional testing was required.
- Shelf Life - The packaging for the subject device is the same as the reference predicate and is labeled with a 3-year expiration date. Real time aging was used to determine the expiration dating. Therefore, no additional testing was required.
- Biocompatibility - The subject device is manufactured from the same material as the reference predicate, uses the same manufacturing method as the predicate, has the same intended use, and the same patient contact type and duration. Therefore, no additional testing was required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.)
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 26, 2017
Nobel Biocare AB % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K171142
Trade/Device Name: Healing Cap Multi-Unit Titanium Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: September 22, 2017 Received: September 25, 2017
Dear Charlemagne Chua:
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.
1
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 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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mary S. Runner -S
for
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Form Approved: OMB No. 0910-0120 |
|---|
| Expiration Date: January 31, 2017 |
| See PRA Statement below. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| 510(k) Number (if known) | K171142 |
|---|---|
| Device Name | Healing Cap Multi-unit Titanium |
| Indications for Use (Describe) | The Healing Cap Multi-unit Titanium is a premanufactured prosthetic component to be directly connected to the dental abutment during soft tissue healing to protect the internal connection of the abutments and prepare the soft tissue for the prosthetic procedure. Maximum intra-oral use is 180-days. |
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
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| FORM FDA 3881 (1/14) | Page 1 of 1 |
|---|---|
| MAR 2017 |
PSC Publishing Services (301) 443-6740
510(k): Healing Cap Multi-unit Titanium
Page 37 of 133
3
510(k) Summary
K171142 I. SUBMITTER
Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE 411 17 Sweden
Submitted by: Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887
Contact Person: Charlemagne Chua, Senior Regulatory Affairs Manager Phone: (714) 282-4800 x 7830 Fax: (714) 998-9348 E-mail address: Charlemagne.chua@nobelbiocare.com
Date Prepared: March 31, 2017
II. DEVICE
Name of Device: Healing Cap Multi-Unit Titanium Common or Usual Name: Dental Abutment Healing Cap Classification Name: Endosseous Dental Implant Abutment (21 CFR 872.3630) Requlatory Class: II Product Code: NHA
III. PREDICATE DEVICE
Primary Predicate: Nobelpharma Branemark System - Healing Cap (K925780)
Reference Predicate: Multi-unit Abutment Plus (K161416)
IV. DEVICE DESCRIPTION
The Healing Cap Multi-unit Titanium is a transmucosal extension secured to Nobel Biocare Multiunit Abutments. It is intended to be used during intra-oral soft tissue healing to protect the internal connection of the MUA Multi-unit Abutments and prepare the soft tissue for the prosthetic procedure (temporary and final restoration). It has a maximum intra-oral use of 180-days.
The Healing Cap Multi-unit titanium portfolio consist of 6 healing cap variants. There are two different caps designs, two heights, and three diameters to accommodate the gingival anatomy and to provide the dentist with options for abutment shoulder visibility and soft tissue retraction.
V. INDICATIONS FOR USE
The Healing Cap Multi-unit Titanium is a premanufactured prosthetic component to be directly connected to the dental abutment during soft tissue healing to protect the internal connection of the abutments and prepare the soft tissue for the procedure. Maximum intra-oral use is 180-days.
Nobel Biocare Traditional 510(k) Notification Healing Cap Mu Ti April 2017
4
| Technological
| characteristics | Subject Device | Predicate |
|---|---|---|
| Design Features | Healing Cap Multi-unit Titanium | Nobelpharma Branemark System - |
| Healing Caps | ||
| (K925780) | ||
| Healing | ||
| Cap | ||
| Design | One-piece Healing Cap |
- Titanium with integrated screw |
| | Materials | Titanium alloy Ti6Al4V ELI
(ASTM F136) |
| | Healing
Cap
Height | 4.1 and 5.5 mm |
| | Healing
Cap
Diameter | 5.0, 6.0, 6.9 mm |
| | Compatible
abutments | Nobel Biocare Multi Unit Abutments
(K072570, K161416, K093643,
K061477) |
| | Intended use | The Healing Cap Multi-unit Titanium is
intended to be used with Multi-unit
abutments during soft tissue healing. |
| Indication for
Use | The Healing Cap Multi-unit Titanium is a
premanufactured prosthetic component
to be directly connected to the dental
abutment during soft tissue healing to
protect the internal connection of the
abutments and prepare the soft tissue for
the prosthetic procedure. Maximum
intra-oral use is 180-days. | No indication statement in submission. |
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Analysis of Differences Between Subject Device and Predicate
The subject device Healing Cap Multi-unit Titanium is a single-piece healing cap made entirely of titanium alloy (ASTM F-136). The predicate Nobelpharma Branemark System - Healing Cap (K925780) has both one-piece healing abutments made entirely of CP titanium and two-piece designs made of plastic with integrated stainless steel screws.
Both subject and predicate devices are intended to be connected to the dental abutment as temporary components during soft tissue healing. The Healing Cap Multi-unit Titanium has a maximum intra-oral use of 180-days.
Nobel Biocare Traditional 510(k) Notification Healing Cap Mu Ti April 2017
5
The subject healing caps are available in three diameters to fit the compatible abutments and two heights that allow the dentist to adapt to the existing soft tissue. The predicate single-piece healing cap is available in only one diameter and height combination. Details regarding the available sizes are in the table above.
The subject healing cap is made of titanium alloy Ti6Al4V ELI (ASTM F136). The predicate single-piece healing Cap is made entirely of commercially pure titanium. The use of titanium alloy will not have an impact on the use of the healing cap.
Summary:
The documentation submitted in the premarket notification demonstrates that the Healing Cap Multi-unit Titanium is substantially equivalent to the predicate device.
VII. PERFORMANCE DATA
Summary of Non-Clinical Testing:
Since the subject device does not represent a new worst case, data from the predicate device was leveraged in the following aspects of the 510(k).
- Sterile Device Information -
- The sterilization method for the subject device is the same as the reference o predicate. The sterilization method is Gamma radiation and has been validated in accordance with ANSI/AAMI/ISO 11137. Therefore, no additional testing was required.
- -Device Packaging
- The packaging for the subject device is the same as the reference predicate. o This is a thermoform tray with peel top lid. Therefore, no additional testing was required.
- -Shelf Life
- o The packaging for the subject device is the same as the reference predicate and is labeled with a 3-year expiration date. Real time aging was used to determine the expiration dating. Therefore, no additional testing was required.
- -Biocompatibility
- The subject device is manufactured from the same material as the reference o predicate, uses the same manufacturing method as the predicate, has the same intended use, and the same patient contact type and duration. Therefore, no additional testing was required.
VIII. CONCLUSIONS
The Healing Cap Multi-unit Titanium was evaluated for substantial equivalence using standard and/or comparative testing. In cases where the Healing Cap Multi-unit Titanium could be shown to not represent a worst-case with respect to the predicates, data from these predicate devices was leveraged to support the subject device. Based on technological characteristics, the Healing Cap Multi-unit Titanium has been shown to be substantially equivalent to the NobelPharma Branemark System Healing Caps (K925780).