(297 days)
The Multi-unit Abutment Plus is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
The Multi-unit Abutment Plus are transmucosal abutments used for multiple unit screw retained restorations. The abutment family consists of straight and angled abutments in varying collar heights. The non-angled abutments have a built in screw and the angled abutments are co-packed with a separate abutment screw. The Multi-unit Abutment Plus is compatible with the Nobel Biocare dental implants that have the internal conical connection. The Multi-unit Abutment Plus is available for Internal Conical Connection implants with the Narrow Platform (NP), Regular Platform (RP) and Wide Platforms (WP). The Multi-unit Abutment Plus is available with collar heights of 1.5, 2.5, 3.5, and 4.5 mm and angulations of 0°, 17°, 30°.
The provided document is a 510(k) premarket notification decision letter from the FDA regarding a dental implant abutment, the "Multi-unit Abutment Plus." This type of document is for medical device clearance, not for AI/ML-based software. Therefore, the information requested regarding acceptance criteria and study details for an AI-based device is not applicable to this document. The document describes the mechanical and material equivalence of a physical dental device to a previously cleared predicate device.
Specifically, the document focuses on:
- Device Description: Multi-unit Abutment Plus (transmucosal abutments for multiple unit screw-retained restorations).
- Comparison to Predicate Device: The subject device is an "evolution" of the predicate (NobelActive Multi Unit Abutment - K072570) with the addition of a Wide Platform (WP) abutment and a "snap coping feature."
- Non-Clinical Testing Summary: The testing primarily involved leveraging data from the predicate device due to similar materials, sterilization methods, packaging, shelf life, and biocompatibility. The primary new test mentioned is fatigue limit testing using a modified ISO 14801 standard, where both the subject and predicate devices were tested under identical conditions.
Therefore, I cannot provide the requested information for an AI/ML device. The questions posed (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are entirely designed for software efficacy studies, which are not detailed or relevant in this hardware device 510(k) submission.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 16, 2017
Nobel Biocare AB c/o Mr. Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887
Re: K161416
Trade/Device Name: Multi-unit Abutment Plus Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: February 10, 2017 Received: February 13, 2017
Dear Mr. 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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{1}------------------------------------------------
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.
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 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. 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 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 yours,
Michael J. Ryan -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}------------------------------------------------
| на | PSC Publishing Services (301) 443-6740 | Page 1 of 1 | Artis For For 1888 (1744 | |
|---|---|---|---|---|
| şərarın qurğuna mərkəzi ərazi var. Bu bir və mənisə çərənin mənalı və mənisələr mənalı mənand the may be and sund of the spensive of beteritse as notiermonity on not only not and the sent medium of the | Department of Health and Human ServicesPaperwork Reduction Act (PRA) StatiOffice of Chief Information Officer | this information collection, including suggestions for reducting this burden, to:้าง แต่เวอร์เดอ ย , ว่า ทิตตุลา การเล่น ค.ศ. 2017 ค.ศ. 2017 ค.ศ. 2017 ค.ศ. 2019 ค.ศ. 2019 ค.ศ. 2019 ค.ศ. 2019 ค.ศ. 2019 ค.ศ. 2019 ค.ศ. 2019 ค.ศ. 2019 ค.ศ. 2019 ค.ศ. 2019 ค.ศA moja a market and source of the on MAO comments on one andsing to to A noticules only the Peninentante Reading Actives singinformation unless it significative a currently valid OMB numberFood and Drug AdministrationPRASSISTINGOfdations.gov | ||
| FOR FDA USE ONLY | Concerters of Centre for Derigoloibes and Radiological (Signing (Signing | |||
| PART PERSELLER | ||||
| Over-The-Counter Use (21 CFFR 801 Subpart C) | 2 Presscription Use (Fart 21 CFR 801 Support D | Type of Use (Select one or both, as applicable) | ||
| The Multified button Plus is a pre-ments streng surficedly connected to the endosseous sent | implant and is intended for use as an aid in proothetic rehabilitation | |||
| Multi-unit Abutunent PlusIndications for Use (Describe,Device Name | ||||
| 510(k) Number (if known1161416 | ||||
| ormandes : OMB No. 0910-0120one the parties damusly 31, 2017PRA Statement below | DEPARTMENT OF FEATH AND HUMA SERVICESndications for UseFood and Drug Administration | |||
· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·
11:10:30 %
ຣຸຟິຈິກອີການປັກ
్లాల
{3}------------------------------------------------
I. SUBMITTER
Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden
Submitted by: Nobel Biocare USA LLC 22715 Savi Ranch Parkwav Yorba Linda, CA 92887
Contact Person: Charlemagne Chua, Senior Regulatory Affairs Manager Phone: (714) 282-4800 x 7830 Fax: (714) 998-9348
Date Prepared: March 15, 2017
II. DEVICE
Name of Device: Multi-unit Abutment Plus Common or Usual Name: Endosseous Dental Implant Abutment Classification Name: Endosseous Dental Implant Abutment (21 CFR 872.3630) Requlatory Class: II Product Code: NHA
III. PREDICATE DEVICE
Primary Predicate: NobelActive Multi Unit Abutment - K072570
Reference Predicate NobelActive Wide Platform (WP) - K133731
IV. DEVICE DESCRIPTION
Multi Unit Abutment Plus
The Multi-unit Abutment Plus are transmucosal abutments used for multiple unit screw retained restorations. The abutment family consists of straight and angled abutments in varying collar heights. The non-angled abutments have a built in screw and the angled abutments are co-packed with a separate abutment screw. The Multi-unit Abutment Plus is compatible with the Nobel Biocare dental implants that have the internal conical connection.
A.4.
{4}------------------------------------------------
The Multi-unit Abutment Plus is available for Internal Conical Connection implants with the Narrow Platform (NP), Regular Platform (RP) and Wide Platforms (WP). The Multi-unit Abutment Plus is available with collar heights of 1.5, 2.5, 3.5, and 4.5 mm and angulations of 0°, 17°, 30°.
Snap Temporary Coping Multi-Unit Titanium
The Temporary Snap Coping is a premanufactured dental abutment directly connected to the Multi-unit abutment plus. The temporary coping is co-packed with a prosthetic screw. It is used as a temporary aid in prosthetic rehabilitation until the final restoration is attached. Maximum intraoral use is 180-days.
V. INDICATIONS FOR USE
The Multi-unit Abutment Plus is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
| Technologicalcharacteristics | Subject Device | Predicate | |
|---|---|---|---|
| Multi-unit Abutment Plus | NobelActive Multi Unit Abutment(K072570) | ||
| Design Features | CompatibleImplantPlatform | Nobel Biocare Internal Conical Connection- Narrow Platform (NP)- Regular Platform (RP)- Wide Platform (WP) | Nobel Biocare Internal ConicalConnection- Narrow Platform (NP)- Regular Platform (RP) |
| Device Material | Abutments and screws – Titaniumvanadium alloy | Abutments and screws – Titaniumvanadium alloy | |
| Abutment collarheight | 1.5, 2.5, 3.5, 4.5 mm | 1.5, 2.5, 3.5, 4.5 mm | |
| Abutment width | 4.8 mm | 4.8 mm | |
| AbutmentAngulation | 0°, 17°, 30° | 0°, 17°, 30° | |
| Intended use | Multi-unit Abutment Plus in combinationwith endosseous implants are intended formultiple unit reconstructions when screwretained prosthetics is preferred. | Multi-unit Abutment in combinationwith endosseous implants are intendedfor multiple unit reconstructions whenscrew retained prosthetics is preferred. | |
| Indication for Use | The Multi-unit Abutment Plus is a pre-manufactured prosthetic componentdirectly connected to the endosseousdental implant and is intended for use asan aid in prosthetic rehabilitation. | NobelActive Multi Unit Abutment is apre-manufactured prostheticcomponent directly connected to theendosseous dental implant and isintended for use as an aid in prostheticrehabilitation. |
VI. Comparison of Technological Characteristics
{5}------------------------------------------------
Analysis of Differences Between Subject Device and Predicate
The Multi-unit Abutment Plus is an evolution of the predicate NobelActive Multi Unit Abutment. It differs from the predicate in the addition of a Wide Platform (WP) abutment (K133731, NobelActive WP, as a reference predicate) and through integration of a snap coping feature. The snap feature, when used with corresponding coping, facilitates try-in by allowing the provisional restoration to be positioned without using screws. Once fitting of the restoration is completed the restoration is secured with prosthetic screws.
Summary:
The documentation submitted in the premarket notification demonstrates that the Multi Unit Plus is substantially equivalent to the predicate device. Differences in technology were evaluated through comparative performance testing.
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
- o The sterilization method for the subject device is the same as the predicate. The sterilization method is Gamma radiation and has been validated in accordance with ANSI/AAMI/ISO 11137. Therefore, no additional testing was required.
- o The Temporary Snap Coping is delivered non-sterile. A sterilization validation was performed to ensure sterility of the subject device when processed by the end user. Sterilization validations were performed using fractionated pre-vacuum and gravity displacement. Sterilization validations were performed with the worst case dental devices.
- Device Packaging -
- The packaging for the subject device is the same as the predicate. O 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 predicate and o is labeled with a 3 year expiration date. Real time aging was used to determine the expiration dating. Therefore, no additional testing was required.
{6}------------------------------------------------
- Biocompatibilitv
- o The subject device is manufactured from the same material as the predicate (K072570, Nobel Biocare), 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.
The fatigue limit of the Multi-unit Abutment Plus was determined using a modified version of ISO 14801. The modifications to ISO 14801 were done to reflect the likely worst-case clinical use of the device. Both the subject and predicate device were tested under identical conditions. The results of the testing were used to address questions related to substantial equivalence based on difference in design between the subiect and predicate devices.
VIII. CONCLUSIONS
The Multi-unit Abutment Plus was evaluated for substantial equivalence using standard and/or comparative testing. In cases where the Multi-unit Abutment Plus 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 and non-clinical test data included in this submission, the Multi-unit Abutment Plus has been shown to be substantially equivalent to the NobelActive Multi Unit Abutment (K072570).
§ 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.)