(141 days)
No
The description focuses on a standard CAD/CAM workflow for customizing a premanufactured abutment blank and does not mention any AI or ML components.
No.
The device is a premanufactured prosthetic component (titanium abutment blank) that is part of a dental restoration system, not a therapeutic device designed to treat or cure a disease or condition. It aids in prosthetic rehabilitation by providing a base for dental prosthetics.
No
Explanation: The device is described as a premanufactured prosthetic component (a titanium abutment blank) used for prosthetic rehabilitation, which is customized and then directly connected to a dental implant. Its purpose is to aid in prosthetic rehabilitation, not to diagnose a condition or disease.
No
The device is a premanufactured titanium abutment blank, which is a physical component intended for implantation. While it is part of a digital workflow involving software, the device itself is hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Titanium Abutment Blank Nobel Biocare N1™ TCC is a premanufactured prosthetic component used in dental rehabilitation. It is customized and then directly connected to a dental implant within the patient's mouth.
- Intended Use: The intended use is for prosthetic rehabilitation, not for analyzing biological specimens to diagnose or monitor a medical condition.
- Workflow: The workflow involves scanning the oral cavity, designing the abutment using CAD software, and milling it using CAM software. This is a manufacturing and placement process, not a diagnostic testing process.
The device is a medical device, specifically a dental prosthetic component, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
"Titanium Abutment Blank Nobel Biocare N1™ TCC is a premanufactured prosthetic component directly connected to an endosseous dental implant and is indicated for use as an aid in prosthetic rehabilitation for single units of up to three units. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories."
Product codes (comma separated list FDA assigned to the subject device)
NHA, PNP
Device Description
"The Titanium Abutment Blank Nobel Biocare N1™ TCC is a premanufactured titanium abutment which can be customized via a validated CAD/CAM workflow in the dental office or dental laboratory to meet patient-specific anatomical requirements. The customization of the subject device is designed using a dental laboratory software and milled in the dental laboratory, using a Computer Aided Design (CAD)/Computer Aided Manufacturing (CAM) machine. All digitally designed CAD/CAM customizations for the Titanium Abutment Blank Nobel Biocare N1™ TCC are only intended to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories. The subject device has a premanufactured connection for the Nobel Biocare N1 ™ TCC TiUltra implants on one end and a premanufactured connection for the milling blank holder on the other end. These connections are not patient-specific. The subject device is available for NP and RP implant platforms. The subject device is used by dental healthcare professionals in dental offices and dental laboratories. The subject device is composed of titanium vanadium alloy Ti6Al4V ELI (ISO 5832-3, ASTM F136) and features a surface with the same anodization already cleared in K211109. It is an implantable single use device. The device is provided non-sterile and intended to be sterilized by the user prior to placement in the patient. The Titanium Abutment Blank Nobel Biocare N1™ TCC is packaged with a Clinical Screw NB N1 TCC."
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
"The subject device is used by dental healthcare professionals in dental offices and dental laboratories."
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)
- End user cleaning and sterilization validation: conducted in accordance with Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, issued March 17, 2015 on the subject device.
- Biocompatibility testing: conducted in accordance with ISO 10993 on the subject device and no new issues regarding biocompatibility were raised for the subject device.
- Fatigue Testing: conducted on the worst-case system of the subject device and leveraged from K220339 in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments", issued May 12, 2004, to demonstrate the subject device is substantially equivalent to the predicate and reference devices.
- Software verification and End-to-end workflow validation: completed on the subject device with the compatible software and designated workflows to demonstrate that applicable restrictions are in place and cannot be modified by the user. Validation testing of CAM restriction zones was conducted on the subject device, including verification to show avoidance of damage or modification of the connection geometry, and locking of restriction zones from user editing in the CAM software.
- MRI compatibility: leveraged from K212125 to demonstrate that the subject device is MR Conditional.
"In conclusion, the results of the non-clinical testing demonstrated that the Titanium Abutment Blank N1™ TCC met the established performance specifications per intended use. The non-clinical testing also demonstrated that the Titanium Abutment Blank N1™ TCC does not raise different questions of substantial equivalence when compared to the respective predicate devices."
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.
K222288, K122602, K212125, K220339
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.)
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Nobel Biocare AB Bernice Jim Head of RA Product Development and Marketed Products Vastra Hamngatan 1 Goteborg, Vastra Gotaland SE 411 17 SWEDEN
Re: K223677
Trade/Device Name: Titanium Abutment Blank Nobel Biocare N1™ TCC Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: March 29, 2023 Received: March 29, 2023
Dear Bernice Jim:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223677
Device Name
Titanium Abutment Blank Nobel Biocare N1TM TCC
Indications for Use (Describe)
Titanium Abutment Blank Nobel Biocare N1™ TCC is a premanufactured prosthetic component directly connected to an endosseous dental implant and is indicated for use as an aid in prosthetic rehabilitation for single units of up to three units. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.
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) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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
Image /page/3/Picture/0 description: The image shows the logo for Nobel Biocare. On the left is a red square with a white "N" inside. To the right of the square is the text "Nobel Biocare" in black. The word "Nobel" is on the top line and "Biocare" is on the bottom line with a trademark symbol.
510(k) Summary K223677
For Titanium Abutment Blank Nobel Biocare N1™ TCC
1. Submitter Information
Submitter:
Nobel Biocare AB P.O. Box 5190, 402 26 Västra Hamngatan 1 Goteborg, SE-411 17 Sweden
Bernice Jim, PhD
+41 43 211 42 00
27 April 2023
Submitted By:
Nobel Biocare Services AG Balz Zimmermann-Str. 7 8302 Kloten Switzerland
regulatory.affairs.nb@envistaco.com
Nicole Fuchs/Corinne Larke-Grass
| Contact Person: |
|---|
| E-Mail: |
| Telephone number: |
| Prepared by: |
| Date Prepared: |
2. Device Name
Proprietary Name: Titanium Abutment Blank Nobel Biocare N1™ TCC Manufacturer: Nobel Biocare AB Generic/Common Name: Abutment, Implant, Dental, Endosseous Requlation Name: Endosseous Dental Implant Abutment Regulation Number: 21 CFR§872.3630 Regulatory Class: ll Primary Product Code: NHA Secondary Product Code: PNP
3. Predicate Device
Predicate Device Proprietary Name: Manufacturer: Generic/Common Name: Regulation Name: Regulation Number: Regulatory Class: ll Primary Product Code: Secondary Product Code: Clearance:
Reference Device #1 Proprietary Name: Manufacturer:
Elos Accurate® Customized Abutment Elos Medtech Pinol A/S Abutment, Implant, Dental, Endosseous Endosseous Dental Implant Abutment 21 CFR§872.3630 NHA PNP K222044
DESS Dental Smart Solutions Terrats Medical SL
4
Image /page/4/Picture/0 description: The image contains the logo for Nobel Biocare. On the left is a red symbol that looks like a stylized letter N. To the right of the symbol is the text "Nobel Biocare" in a simple, sans-serif font. The word "Nobel" is above the word "Biocare", and there is a trademark symbol after the word "Biocare".
| Generic/Common Name: | Abutment, Implant, Dental, Endosseous |
|---|---|
| Regulation Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR§872.3630 |
| Regulatory Class: | II |
| Primary Product Code: | NHA |
| Clearance: | K222288 |
| Reference Device #2 | |
| Proprietary Name: | NobelProcera Ti Abutment Camlog Platforms |
| Manufacturer: | Nobel Biocare AB |
| Generic/Common Name: | Abutment, Implant, Dental, Endosseous |
| Regulation Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR§872.3630 |
| Regulatory Class: | II |
| Product Code: | NHA |
| Clearance: | K122602 |
| Reference Device #3 | |
| Proprietary Name: | Nobel Biocare Dental Implant Systems Portfolio - MR Conditional |
| Manufacturer: | Nobel Biocare AB |
| Generic/Common Name: | Implant, Dental, Endosseous |
| Regulation Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3640, 21 CFR 872.3630, 21 CFR 872.4120 |
| Regulatory Class: | II |
| Product Code: | DZE, NHA, PNP, DZI |
| Clearance: | K212125 |
| Reference Device #4 | |
| Proprietary Name: | Esthetic Abutments Nobel Biocare N1 ™ |
| Manufacturer: | Nobel Biocare AB |
| Generic/Common Name: | Abutment, Dental, Endosseous |
| Regulation Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR§872.3630 |
| Regulatory Class: | II |
| Product Code: | NHA |
| Clearance: | K220339 |
4. Device Description
The Titanium Abutment Blank Nobel Biocare N1™ TCC is a premanufactured titanium abutment which can be customized via a validated CAD/CAM workflow in the dental office or dental laboratory to meet patient-specific anatomical requirements. The customization of the subject device is designed using a dental laboratory software and milled in the dental laboratory, using a Computer Aided Design (CAD)/Computer Aided Manufacturing (CAM) machine.
5
Image /page/5/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a red letter N on the left and the words "Nobel Biocare" on the right. The letter N is stylized and made up of two intersecting lines. The word "Nobel" is above the word "Biocare", and there is a trademark symbol after the word "Biocare".
All digitally designed CAD/CAM customizations for the Titanium Abutment Blank Nobel Biocare N1™ TCC are only intended to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.
The subject device has a premanufactured connection for the Nobel Biocare N1 ™ TCC TiUltra implants on one end and a premanufactured connection for the milling blank holder on the other end. These connections are not patient-specific.
The subject device is available for NP and RP implant platforms.
The subject device is used by dental healthcare professionals in dental offices and dental laboratories.
The subject device is composed of titanium vanadium alloy Ti6Al4V ELI (ISO 5832-3, ASTM F136) and features a surface with the same anodization already cleared in K211109.
It is an implantable single use device. The device is provided non-sterile and intended to be sterilized by the user prior to placement in the patient.
The Titanium Abutment Blank Nobel Biocare N1™ TCC is packaged with a Clinical Screw NB N1 TCC.
| Subject Device | 301511 – Ti Abutment
Blank NB N1 TCC NP
Ø10 mm | 301512 – Ti Abutment
Blank NB N1 TCC RP
Ø10 mm |
|-------------------------------------------------------|------------------------------------------------------|------------------------------------------------------|
| Maximum abutment angulation | | 30° |
| Minimum screw channel thickness (min. wall thickness) | 0.38mm | 0.49mm |
| Maximum abutment height from implant level | | 16mm |
| Minimum diameter | 3.21mm | 3.49mm |
| Maximum diameter | | 9.95mm |
| Minimum post height | | 4.05mm |
| Maximum post height | | 15.665mm |
| Minimum gingival margin height | | 0.335mm |
| Maximum margin height | | 4.6mm |
Table 1: Design Parameters
Principle of Operation / Mechanism of Action
The customized subject device acts as connecting element between a dental implant and a restoration. The mechanism of action is a mechanical screw connection, through the use of a clinical screw, and through a cemented connection to a restoration.
6
Image /page/6/Picture/0 description: The image contains the logo for Nobel Biocare. On the left side of the logo is a red symbol that looks like the letter N. To the right of the symbol is the company name, Nobel Biocare, in black font. The word Nobel is on the top line, and Biocare is on the second line with the trademark symbol.
Compatible Devices:
The Titanium Abutment Blanks Nobel Biocare N1™ TCC are compatible with N1™ TiUltra TCC implants.
5. Indications for Use
Titanium Abutment Blank Nobel Biocare N1™ TCC is a premanufactured prosthetic component directly connected to an endosseous dental implant and is indicated for use as an aid in prosthetic rehabilitation for single units and multiple units of up to three units.
The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.
6. Description of Substantial Equivalence
Overall, the subject device has the following substantial equivalences to the predicate device: similar intended use, the same operating principle, incorporates a similar basic design, incorporates the same materials, customizes to fit patient specific anatomical requirements, same methods of sterility and requires a digital dentistry workflow to manufacture at point of care .
Both subject and predicate abutment devices are premanufactured prosthetic components directly connected to the endosseous dental implant and are intended for use as an aid in prosthetic rehabilitation. Therefore, the devices are substantially equivalent in the consideration of intended use and Indications for Use.
The technological differences between the subject and the predicate device do not affect the shared intended use nor raise different questions of substantial equivalence, as demonstrated by non-clinical testing.
Table 2 below shows the substantial equivalence comparison for the subject device.
7
Image /page/7/Picture/0 description: The image contains the logo for Nobel Biocare. The logo consists of a red square with a white "N" inside of it. To the right of the square is the text "Nobel Biocare™" in black font.
| Table 2: Titanium Abutment Blank Nobel Biocare N1™ TCC comparison table | |
|---|---|
| ------------------------------------------------------------------------- | -- |
| Characteristic | Subject Device
Titanium Abutment Blank Nobel
Biocare N1 TCC | Predicate Device
Elos Accurate® Customized
Abutment | Reference Device #1
DESS Dental Smart Solutions | Reference Device #2
NobelProcera Ti Abutment
Camlog Platforms | Comparison |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| | K223677 | K222044 | K222288 | K122602 | |
| Product
Classification | Class II | Class II | Class II | Class II | Identical |
| Regulation Number
/ Name | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | Identical |
| | Endosseous Dental Implant
Abutment | Endosseous Dental Implant
Abutment | Endosseous Dental Implant
Abutment | Endosseous Dental Implant
Abutment | Identical |
| Product Code,
primary | NHA | NHA | NHA | NHA | Identical |
| Product Code,
secondary | PNP | PNP | N/A | NHA | Identical |
| Review Panel | Dental | Dental | Dental | Dental | Identical |
| Intended Use | Intended to be connected to an
endosseous dental implant to
support the placement of a dental
prosthesis. | Support of a prosthesis to restore
chewing function. | -- | -- | Similar intended use
as the Primary
Predicate
expressed through
a similar choice of
words. |
| Characteristic | Subject Device | Predicate Device | Reference Device #1 | Reference Device #2 | Comparison |
| | Titanium Abutment Blank Nobel
Biocare N1 TCC | Elos Accurate® Customized
Abutment | DESS Dental Smart Solutions | NobelProcera Ti Abutment
Camlog Platforms | |
| | K223677 | K222044 | K222288 | K122602 | |
| Indications for Use | Titanium Abutment Blank Nobel
Biocare N1™ TCC is a
premanufactured prosthetic
component directly connected to
an endosseous dental implant and
is indicated for use as an aid in
prosthetic rehabilitation for single
units and multiple units of up to
three units
The system integrates multiple
components of the digital dentistry
workflow: scan files from Intra-Oral
Scanners, CAD software, CAM
software, milling machine and
associated tooling and accessories | The Elos Accurate® Customized
Abutments are intended for
attaching to dental implants in
order to
provide basis for single or multiple
tooth prosthetic restorations. The
Elos Accurate® Customized
Abutment will be attached to a
dental implant using the included
Elos Prosthetic screw.
The Elos Accurate® Customized
Abutments are compatible with the
implant systems listed in Table 1:
All digitally designed CAD/CAM
customizations for the Elos
Accurate® Customized Abutments
are only
intended to be designed and
manufactured according to digital
dentistry workflow. The workflow
system integrates multiple
components of the digital dentistry
workflow: scan files from Intra-Oral
Scanners, CAD software, CAM
software, milling machine and
associated tooling and
accessories. | DESS Dental Smart Solutions
abutments are intended to be used
in conjunction with endosseous
dental implants in the maxillary or
mandibular arch to provide support
for prosthetic restorations.
All digitally designed custom
abutments for use with Ti Base
abutments or Pre-milled Blank
abutments are to be sent to a
Terrats Medical validated milling
center for manufacture. | The NobelProcera Ti Abutments
Camlog Platforms are
premanufactured prosthetic
components directly connected to
endosseous dental implants and
are
intended for use as an aid in
prosthetic rehabilitation. They are
compatible with the Camlog K
series 3.3, 3.8, 4.3, 5.0 and 6.0
implants. | Similar Indications
for Use as the
Primary Predicate
expressed through
a similar choice of
words. |
| Minimum wall
thickness: | NP 0.38mm
RP 0.49mm | 0.4 - 0.5mm (Implant Platform
dependent) | 0.45mm | 0.3mm
-- | Similar as reference
device #2.
Substantial
equivalence, as
demonstrated by
fatigue testing. |
| Characteristic | Subject Device | Predicate Device | Reference Device #1 | Reference Device #2 | |
| | Titanium Abutment Blank Nobel
Biocare N1 TCC | Elos Accurate® Customized
Abutment | DESS Dental Smart Solutions | NobelProcera Ti Abutment
Camlog Platforms | Comparison |
| | K223677 | K222044 | K222288 | K122602 | |
| Minimum gingiva
height: | 0.335 mm | 0.5mm | 0.3mm | -- | Similar as reference
device #1.
Substantial
equivalence, as
demonstrated by
fatigue testing. |
| Minimum diameter | NP Ø3.21mm
RP Ø3.49mm | 3.0 - 6.0 mm (Implant Platform
dependent) | 2.52 - 6.0 mm (Implant Platform
dependent) | -- | Similar |
| Minimum post
height: | 4.05mm | 4mm | 4mm | -- | Similar |
| Abutment Shape | Patient specific | Patient specific | Patient specific | Patient Specific | Identical |
| Platform
compatibility | Narrow Platform (NP)
Regular Platform (RP) | Narrow Platform (NP)
Regular Platform (RP) | Narrow Platform (NP)
Regular Platform (RP) | 3.3, 3.8, 4.3, 5.0, 6.0 | Identical |
| Attachment
method to implant | Screw retained | Screw retained | Screw retained | Screw retained | Identical |
| Prosthesis
attachment method | Cement retained | Cement retained | Screw or cement retained | Cement retained | Identical |
| Restoration type | Single-unit and multi-unit (up to 3
units) | Single-unit and multi-unit | Single-unit and multi-unit | Single-unit | Similar |
| Design features | Pre-manufactured implant-
interface connection, customizable
cylindrical abutment body | Pre-manufactured implant-
interface connection, customizable
cylindrical abutment body | -- | Pre-manufactured implant-
interface connection, customizable
cylindrical abutment body | Identical |
| Principle of
operation/
Mechanism of
action | Mechanical screw connection | Mechanical screw connection | -- | Mechanical screw connection | Identical |
| Characteristic | Subject Device | Predicate Device | Reference Device #1 | Reference Device #2 | Comparison |
| | Titanium Abutment Blank Nobel
Biocare N1 TCC | Elos Accurate® Customized
Abutment | DESS Dental Smart Solutions | NobelProcera Ti Abutment
Camlog Platforms | |
| | K223677 | K222044 | K222288 | K122602 | |
| Maximum
abutment
angulation | 30° | 30°/20° depending on the implant
platform | 30° | 0° | Identical |
| Material | Ti6Al4V ELI (ISO 5832-3, ASTM
F136) | Ti6Al4V ELI (ISO 5832-3, ASTM
F136) | Ti6Al4V ELI (ISO 5832-3, ASTM
F136) | CP Titanium
Titanium/vanadium alloy | Identical |
| Design Workflow | Kavo LS3, 3Shape Trios or other
scanners with equal or higher
accuracy than 6.9 µm
3Shape Abutment Designer
Software (3Shape A/S) -K151455
AbutmentCAD (ExoCAD) -
K193352
DTX Studio design (Nobel Biocare
USA LLC) - K181932 | 3Shape scanner (3Shape A/S)
3Shape Abutment Designer
Software (3Shape A/S) -K151455 | -- | Procera System Software
(K053602) | Similar to predicate.
Substantial
equivalence, as
demonstrated by
software verification
and end-to-end
workflow validation |
| Manufacturing
Workflow | CORITEC by imes-icore | CORITEC by imes-icore | -- | -- | Identical |
8
Image /page/8/Picture/0 description: The image contains the logo for Nobel Biocare. On the left is a red symbol that looks like a stylized letter N. To the right of the symbol is the text "Nobel Biocare" with the trademark symbol next to it. The text is in a simple, sans-serif font.
9
Image /page/9/Picture/0 description: The image contains the logo for Nobel Biocare. The logo consists of a red square with a stylized "N" inside of it. To the right of the square is the text "Nobel Biocare" in black font. The word "Nobel" is above the word "Biocare".
10
Image /page/10/Picture/0 description: The image contains the logo for Nobel Biocare. On the left is a red square with a stylized white "N" inside. To the right of the square are the words "Nobel" on top and "Biocare" on the bottom, with a trademark symbol after the word Biocare.
11
Image /page/11/Picture/0 description: The image contains the logo for Nobel Biocare. The logo consists of a stylized red letter "N" on the left, followed by the words "Nobel" and "Biocare" stacked on top of each other on the right. The "Biocare" text has a trademark symbol next to it.
7. Non-Clinical Test Data
The following performance tests were submitted in this 510(k) to support substantial equivalence and demonstrate that the subject device is as safe and as effective as its predicate device:
- End user cleaning and sterilization validation was conducted in . accordance with Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, issued March 17, 2015 on the subject device.
- . Biocompatibility testing was conducted in accordance with ISO 10993 on the subject device and no new issues regarding biocompatibility were raised for the subject device.
- . Fatique Testing was conducted on the worst-case system of the subject device and leveraged from K220339 in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments", issued May 12, 2004, to demonstrate the subject device is substantially equivalent to the predicate and reference devices.
- Software verification and End-to-end workflow validation was completed . on the subject device with the compatible software and designated workflows to demonstrate that applicable restrictions are in place and cannot be modified by the user. To address the potential risk of damage to the implant-abutment connection geometry during the milling of the patient-matched portions of the abutment blanks, validation testing of CAM restriction zones was conducted on the subject device, including verification to show avoidance of damage or modification of the connection geometry, and locking of restriction zones from user editing in the CAM software.
- . MRI compatibility was leveraged from K212125 to demonstrate that the subject device is MR Conditional.
In conclusion, the results of the non-clinical testing demonstrated that the Titanium Abutment Blank N1™ TCC met the established performance specifications per intended use. The non-clinical testing also demonstrated that the Titanium Abutment Blank N1™ TCC does not raise different questions of substantial equivalence when compared to the respective predicate devices.
8. Clinical Performance Data
Clinical data was not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterized all performance aspects of the Subject Device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this device.
9. Conclusion
The Titanium Abutment Blank Nobel Biocare N1™ TCC was evaluated for substantial equivalence using standard and/or comparative testing. Based on a comparison of
12
Image /page/12/Picture/0 description: The image contains the logo for Nobel Biocare. On the left is a red square with a stylized white "N" inside. To the right of the square are the words "Nobel Biocare" stacked on top of each other in black font. The "Biocare" has a trademark symbol next to it.
intended use, Indications for Use, material composition, technological characteristics, features, and performance data the Titanium Abutment Blank Nobel Biocare N1 ™ TCC is at least as safe and effective as the predicate devices, and substantial equivalence to the predicate device is therefore supported.