Who is the manufacturer of Temporary Snap Abutment?

Nobel Biocare AB filed the 510(k) submission for Temporary Snap Abutment (K161435).

What is the FDA product code for Temporary Snap Abutment?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Temporary Snap Abutment?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Temporary Snap Abutment?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Temporary Snap Abutment

Q: What are the predicate devices for Temporary Snap Abutment?

Plastic Temporary Abutment (K092377).

K161435 · Nobel Biocare AB · NHA · Nov 22, 2016 · Dental

Device Facts

Record ID	K161435
Device Name	Temporary Snap Abutment
Applicant	Nobel Biocare AB
Product Code	NHA · Dental
Decision Date	Nov 22, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Temporary Snap Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the gingiva during the healing period and prior to final restoration. The Temporary Snap Abutment can be used for cement retained or screw-retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations. Use of the Temporary Snap Abutment is not to exceed one hundred and eighty (180) days.

Device Story

Temporary Snap Abutment; premanufactured dental implant abutment; connects to endosseous dental implants; facilitates prosthetic try-in via integrated snap feature; snap feature allows positioning without screws using friction; final restoration secured with prosthetic screws; used by dental professionals in clinical settings; aids in creating esthetic emergence through gingiva during healing; supports provisional restorations; benefits patient by enabling temporary prosthetic rehabilitation prior to final restoration.

Clinical Evidence

Bench testing only. Biocompatibility assessed via cytotoxicity and GC-MS analysis per EN ISO 10993-1; no cytotoxic effects or leachables detected. Sterilization validated using autoclaves per AAMI TIR12: 2010. Packaging verified as identical to predicate.

Technological Characteristics

Materials: Titanium vanadium alloy (ASTM F1472, ASTM F136). Connection: Internal conical (NP, RP, WP). Design: Engaging/non-engaging, 1.5/3.0 mm collar heights, 4.0/4.5/6.0 mm widths. Sterilization: Autoclave (fractionated prevacuum/gravity).

Indications for Use

Indicated for patients requiring provisional dental restorations during the healing period prior to final restoration; supports single-unit and multi-unit cement or screw-retained restorations; duration of use not to exceed 180 days.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

Plastic Temporary Abutment (K092377)

Reference Devices

NobelProcera PEEK Abutments (K120954)
NobelActive Wide Platform (WP) (K133731)

Related Devices

K072679 — P.004 ABUTMENTS · Institut Straumann AG · Oct 12, 2007
K230126 — Dentis s-Clean Regular Abutment · Dentis Co., Ltd. · Aug 4, 2023
K974628 — FRIALIT-2 PROTECT ABUTMENT · Friatec AG · Mar 11, 1998
K120954 — NOBELPROCERA PEEK ABUTMENTS · Nobel Biocare AB · Jun 5, 2013
K112099 — CONTOUR HEALER · Contour Healer, LLC · Feb 3, 2012

Submission Summary (Full Text)

{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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with a series of human profiles facing to the right. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 22, 2016 Nobel Biocare AB % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887 Re: K161435 Trade/Device Name: Temporary Snap Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: October 26, 2016 Received: October 27, 2016 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. 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}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K161435 Device Name Temporary Snap Abutment ### Indications for Use (Describe) The Temporary Snap Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the healing period and prior to final restoration. The Temporary Snap Abutment can be used for cement retained or screw-retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations. Use of the Temporary Snap Abutment is not to exceed one hundred and eighty (180) days. Type of Use (Select one or both, as applicable) 2 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 Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ I. SUBMITTER Nobel Biocare AB VastraHamngatan 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: November 18, 2016 II. DEVICE Name of Device: Temporary Snap Abutment Common or Usual Name: Endosseous Dental Implant Abutment Classification Name:Endosseous Dental Implant Abutment (21 CFR 872.3630) Regulatory Class: II Product Code: NHA III.PREDICATE DEVICE Primary Predicate Plastic Temporary Abutment (K092377) Reference Predicate NobelProcera PEEK Abutments (K120954) Reference Predicate NobelActive Wide Platform (WP) (K133731) IV. DEVICE DESCRIPTION The Temporary Snap Abutments are premanufactured dental implant abutments directly connected to endosseous dental implants and are intended for use as a temporary aid in prosthetic rehabilitation. A.4. {4}------------------------------------------------ The Temporary Snap Abutments are available in engaging and non-engaging connection designs and with collar heights of 1.5 and 3.0 mm. The Temporary Snap Abutments are compatible with the Nobel Biocare dental implants that have the Narrow Platform (NP), Regular Platform (RP) or Wide Platforms (WP) internal conical connection. ## V. INDICATIONS FOR USE The Temporary Snap Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the gingiva during the healing period and prior to final restoration. The Temporary Snap Abutment can be used for cement retained or screw-retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations. Use of the Temporary Snap Abutment is not to exceed one hundred and eighty (180) days. {5}------------------------------------------------ # VI. Comparison of Technological Characteristics | Technological characteristics | | Subject Device | Primary Predicate | Reference Predicate | Reference Predicate | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | Temporary Snap Abutment | Plastic Temporary Abutment (K092377) | NobelProcera PEEK Abutments (K120954) | NobelActive Wide Platform (WP) (K133731) Temporary Abutment Only | | Design Features | Compatible Implant Platform | Nobel Biocare Internal Conical Connection - Narrow Platform (NP) - Regular Platform (RP) - Wide Platform (WP) | Zimmer Dental Tapered Screw Vent - 3.5, 4.5, and 5.7 mm Platform Screw Vent - 3.5, 4.5, and 5.7 mm Platform | Nobel Biocare - Internal Conical Connection (NP, RP) - External Hex (NP, RP, WP) - Internal Tri-lobe (NP, RP, WP) | Nobel Biocare Internal Conical Connection - Wide Platform (WP) | | | Device Material | Abutments and screws - Titanium vanadium alloy (ASTM F1472, ASTM F136) | Abutment - PEEK white Screws - Unknown | Abutment - PEEK white and natural color Screws - Titanium vanadium alloy (ASTM F1472, ASTM F136) | Abutments and screws - Titanium vanadium alloy (ASTM F1472, ASTM F136) | | | Abutment collar height | 1.5, 3.0 mm | 1.0, 4.0 mm | 1.0, 1.5 mm | 1.5, 3.0 mm | | | Abutment width | 4.0, 4.5, 6.0 mm | 4.5, 5.5, 6.5 mm | 4.3, 5.0, 6.0 mm | 6.0 mm | | | Abutment Angulation | No angulation | Straight and angled | No angulation | No angulation | | Intended use | | Temporary Snap Abutments are endosseous dental implant abutments that are designed for single use as a temporary prosthesis during the healing process while the permanent prosthesis is fabricated. | The Plastic Temporary Abutments are endosseous dental implant abutments that are designed for single use as a temporary prosthesis during the healing process while the permanent prosthesis is fabricated. | The NobelProcera PEEK Abutments are endosseous dental implant abutments that are designed for single use as a temporary prosthesis during the healing process while the permanent prosthesis is fabricated. | TheNobelActive Wide Platform Temporary Abutments are endosseous dental implant abutments that are designed for single use as a temporary prosthesis during the healing process while the permanent prosthesis is fabricated. | | | Subject Device | Primary Predicate | Reference Predicate | Reference Predicate | | | Technological characteristics | Temporary Snap Abutment | Plastic Temporary Abutment (K092377) | NobelProcera PEEK Abutments (K120954) | NobelActive Wide Platform (WP) (K133731) Temporary Abutment Only | | | Indication for Use | The Temporary Snap Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the gingiva during the healing period and prior to final restoration. The Temporary Snap Abutment can be used for cement retained or screw- retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations. Use of the Temporary Snap Abutment is not to exceed one hundred and eighty (180) days. | The Plastic Temporary Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the gingiva during the healing period and prior to final restoration. The Plastic Temporary Abutment can be used for cement retained or screw-retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations. Use of the Plastic Temporary Abutment is not to exceed one hundred and eighty (180) days. | The Nobel Biocare PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation | Nobel Biocare's NobelActive implants are endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NobelActive implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's NobelActive implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. | | {6}------------------------------------------------ {7}------------------------------------------------ Analysis of Differences Between Subject Device and Predicate The Temporary Snap Abutment differs from the predicates through the integration of a snap feature designed to facilitate prosthetic try in. This difference is detailed below. All other technological characteristics of the Temporary Snap Abutment are shared with one or more of the primary and reference predicates. The Temporary Snap Abutment incorporates a snap feature. The snap feature facilitates try-in by allowing the provisional restoration to be positioned without using screws. Friction between the implant and abutment holds the abutment in position during the try-in process. Once fitting of the restoration is completed the restoration is secured with prosthetic screws. The inclusion of the snap feature on the Temporary Snap Abutment did not necessitate any modifications to the implant connection. ## Summary: The design differences between the subject and predicate devices do not query the substantial equivalence. ## VII. PERFORMANCE DATA ## Summary of Non-Clinical Testing: Since the subject device does not represent a new worst case, data from the predicate device (K133731) was leveraged in the following aspects of the 510(k). - Device Packaging - o The packaging for the subject device is the same as the predicate. This is a thermoform tray with peel top lid. Therefore, no additional testing was required. - -Biocompatibilitv - o The subject device is manufactured from titanium vanadium alloy (ASTM F136 and ASTM F1472) using the same manufacturing method as the predicate, has the same intended use, and the same patient contact type and duration. To assess, Cytotoxcity and GC-MS analysis was performed in accordance with EN ISO 10993-1 and confirmed no leachables or no cytotoxic effect detected. No additional testing was required. - -Sterilization - Sterilization validations were performed to ensure the sterility of the o subject devices when processed by the end user. The sterilization validations were performed using autoclaves with fractionated prevacuum and gravity specific air displacement. The sterilizations were performed with worst case dental devices as described in the AAMI TIR12: 2010. {8}------------------------------------------------ ## VIII. CONCLUSIONS The Temporary Snap Abutment was evaluated for substantial equivalence using standard and/or comparative testing. In cases where the Temporary Snap Abutment 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 included in this submission, the Temporary Snap Abutment has been shown to be substantially equivalent to the predicate devices.