(182 days)
No
The 510(k) summary describes a physical dental implant abutment and its intended use, materials, and testing. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The testing described is focused on material properties, packaging, and sterilization.
No.
The device is intended for prosthetic rehabilitation and to support provisional restorations, not to treat a disease or medical condition.
No
Explanation: The device is described as a "Temporary Snap Abutment" used to fabricate and support provisional restorations for dental implants, aiding in esthetic emergence and prosthetic rehabilitation. Its purpose is to provide a temporary structural and esthetic solution, not to diagnose a condition or disease.
No
The device description clearly states it is a premanufactured dental implant abutment made from titanium vanadium alloy, 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 fabricate and support provisional dental restorations. This is a mechanical function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a premanufactured dental implant abutment, which is a physical component used in dental procedures.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a medical device used in a surgical/restorative procedure, not a diagnostic test.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
NHA
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.
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 (K133731) was leveraged in the following aspects of the 510(k).
- Device Packaging
- 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.
- Biocompatibility
- 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, Cytotoxicity 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 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.
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.
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.)
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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
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
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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)
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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.
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.
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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.