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.

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. 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.

AI/ML Overview

While the provided document is a 510(k) premarket notification for a medical device (Temporary Snap Abutment), it does not contain the information required to answer your request about acceptance criteria and a study proving the device meets those criteria.

Here's why and what the document does provide:

Type of Document: This is a submission to the FDA seeking a determination of "substantial equivalence" to a predicate device. This process focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate, often by showing it has the same technological characteristics or that any differences do not raise new questions of safety or effectiveness. It typically relies on comparison to existing devices and performance data from those predicates, rather than extensive de novo clinical trials or detailed performance metrics for the new device itself.
Missing Information:
1. Acceptance Criteria Table: There is no table of acceptance criteria for the Temporary Snap Abutment's performance. The document focuses on comparing its technological characteristics and intended use to predicate devices.
2. Reported Device Performance: While "Summary of Non-Clinical Testing" is mentioned, it only discusses biocompatibility and sterilization validations, leveraging data from the predicate. It does not provide specific performance metrics for the Temporary Snap Abutment itself (e.g., strength, durability, fit, etc.) Nor does it describe a study that directly tests these performance aspects of the subject device against specific acceptance criteria.
3. Sample Sizes and Data Provenance for Test Set: Not applicable, as there's no described performance study for the subject device. The biocompatibility and sterilization "testing" mentioned doesn't involve a test set in the way a clinical or performance study would.
4. Number of Experts/Qualifications for Ground Truth: Not applicable, as there's no ground truth establishment for a performance study of the subject device.
5. Adjudication Method: Not applicable.
6. MRMC Comparative Effectiveness Study: There is no mention of an MRMC study.
7. Standalone Performance: While non-clinical testing for biocompatibility and sterilization is mentioned, it's not a "standalone performance" study in the sense of demonstrating the device's functional efficacy or safety attributes as a new device against specific criteria. Instead, it leverages predicate data.
8. Type of Ground Truth: Not applicable.
9. Training Set Sample Size/Ground Truth for Training: Not applicable, as this document is not describing a machine learning or AI device that would have a training set.

What the document does state regarding performance/testing:

The document states that the subject device does not represent a new worst case compared to the predicate (K133731). Therefore, data from the predicate was leveraged for:

Device Packaging: Same as predicate, no additional testing required.
Biocompatibility: Subject device is made from the same material (titanium vanadium alloy ASTM F136 and ASTM F1472) using the same manufacturing method, has the same intended use and patient contact type/duration as the predicate. Cytotoxicity and GC-MS analysis were performed in accordance with EN ISO 10993-1 (a standard), confirming no leachables or cytotoxic effect. No additional testing was required for the subject device itself beyond this.
Sterilization: Validations were performed to ensure sterility of the subject devices when processed by the end user. These were done using autoclaves with fractionated prevacuum and gravity specific air displacement, with worst-case dental devices as described in AAMI TIR12: 2010.

In summary, this 510(k) submission primarily relies on demonstrating substantial equivalence through comparison of design features, materials, and intended use to legally marketed predicate devices, along with leveraging existing biocompatibility and sterilization data from analogous devices or standard testing protocols, rather than presenting a detailed study of the subject device's performance against specific, quantifiable acceptance criteria.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K161435

Device Name Temporary Snap Abutment

Indications for Use (Describe)

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:

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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.

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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.

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VI. Comparison of Technological Characteristics

Technologicalcharacteristics		Subject Device	Primary Predicate	Reference Predicate	Reference Predicate
		Temporary Snap Abutment	Plastic Temporary Abutment(K092377)	NobelProcera PEEKAbutments (K120954)	NobelActive Wide Platform(WP) (K133731)Temporary Abutment Only
Design Features	CompatibleImplantPlatform	Nobel Biocare InternalConical Connection- Narrow Platform (NP)- Regular Platform (RP)- Wide Platform (WP)	Zimmer DentalTapered Screw Vent- 3.5, 4.5, and 5.7 mmPlatformScrew Vent- 3.5, 4.5, and 5.7 mmPlatform	Nobel Biocare- Internal ConicalConnection (NP, RP)- External Hex (NP, RP,WP)- Internal Tri-lobe (NP,RP, WP)	Nobel Biocare InternalConical Connection- Wide Platform (WP)
	DeviceMaterial	Abutments and screws -Titanium vanadium alloy(ASTM F1472, ASTM F136)	Abutment - PEEK whiteScrews - Unknown	Abutment - PEEK white andnatural colorScrews - Titanium vanadiumalloy (ASTM F1472, ASTMF136)	Abutments and screws -Titanium vanadium alloy(ASTM F1472, ASTMF136)
	Abutmentcollarheight	1.5, 3.0 mm	1.0, 4.0 mm	1.0, 1.5 mm	1.5, 3.0 mm
	Abutmentwidth	4.0, 4.5, 6.0 mm	4.5, 5.5, 6.5 mm	4.3, 5.0, 6.0 mm	6.0 mm
	AbutmentAngulation	No angulation	Straight and angled	No angulation	No angulation
Intended use		Temporary Snap Abutmentsare endosseous dentalimplant abutments that aredesigned for single use as atemporary prosthesis duringthe healing process while thepermanent prosthesis isfabricated.	The Plastic TemporaryAbutments are endosseousdental implant abutments thatare designed for single useas a temporary prosthesisduring the healing processwhile the permanentprosthesis is fabricated.	The NobelProcera PEEKAbutments are endosseousdental implant abutmentsthat are designed for singleuse as a temporaryprosthesis during the healingprocess while the permanentprosthesis is fabricated.	TheNobelActive WidePlatform TemporaryAbutments areendosseous dental implantabutments that aredesigned for single use asa temporary prosthesisduring the healing processwhile the permanentprosthesis is fabricated.
	Subject Device	Primary Predicate	Reference Predicate	Reference Predicate
Technologicalcharacteristics	Temporary Snap Abutment	Plastic Temporary Abutment(K092377)	NobelProcera PEEKAbutments (K120954)	NobelActive Wide Platform(WP) (K133731)Temporary Abutment Only
Indication forUse	The Temporary SnapAbutment is intended to beused to fabricate and supportprovisional restorations thataid in creating an estheticemergence through thegingiva during the healingperiod and prior to finalrestoration. The TemporarySnap Abutment can be usedfor cement retained or screw-retained provisionalrestorations. The abutmentscan be used for single-unitand multi-unit restorations.Use of the Temporary SnapAbutment is not to exceedone hundred and eighty (180)days.	The Plastic TemporaryAbutment is intended to beused to fabricate and supportprovisional restorations thataid in creating an estheticemergence through thegingiva during the healingperiod and prior to finalrestoration. The PlasticTemporary Abutment can beused for cement retained orscrew-retained provisionalrestorations. The abutmentscan be used for single-unitand multi-unit restorations.Use of the Plastic TemporaryAbutment is not to exceedone hundred and eighty (180)days.	The Nobel Biocare PEEKAbutments arepremanufactured prostheticcomponents directlyconnected to endosseousdental implants and areintended for provisional useup to 180 days as an aid inprosthetic rehabilitation	Nobel Biocare'sNobelActive implants areendosseous implantsintended to be surgicallyplaced in the bone of theupper or lower jaw archesto provide support forprosthetic devices, suchas an artificial tooth, inorder to restore patientesthetics and chewingfunction. Nobel Biocare'sNobelActive implants areindicated for single ormultiple unit restorations insplinted or non-splintedapplications. NobelBiocare's NobelActiveimplants are intended forimmediate loading whengood primary stability isachieved and withappropriate occlusalloading.

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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.

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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.

Regulation Number and Section

§ 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.)