(118 days)
No
The document describes a CAD/CAM process for creating patient-matched dental abutments and screws, but there is no mention of AI or ML being used in the design, manufacturing, or function of the device. The customization is described as being defined by the customer and performed at a production facility.
Yes
The device is indicated as an "aid in prosthetic rehabilitation" to "restore chewing function and esthetic appearance," which are therapeutic goals.
No.
The device is a prosthetic component (abutment and screw) used in dental rehabilitation to support tooth replacements, not for diagnosing medical conditions.
No
The device description clearly states that the device is a physical component made of titanium vanadium alloy and undergoes manufacturing processes. It is a patient-matched CAD/CAM dental prosthesis, but the final product is a physical abutment and screw, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the NobelProcera® Titanium ASC Abutments and Omnigrip Clinical Screws are prosthetic components used to connect to dental implants and support tooth replacements. They are physical devices implanted in the body to restore function and appearance.
- Lack of Diagnostic Activity: There is no mention of the device analyzing biological samples or providing diagnostic information about a patient's health status. Its purpose is purely mechanical and restorative.
The text focuses on the device's materials, design, intended use in prosthetic rehabilitation, and performance testing related to mechanical strength, biocompatibility, and MR compatibility – all characteristics of a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
NobelProcera® Titanium ASC Abutments:
NobelProcera® Abutment Titanium is a patient-matched CAD/CAM prosthetic component directly connected to endosseous dental implants and is indicated for use as an aid in prosthetic rehabilitation.
Omnigrip Clinical Screw Titanium:
Clinical and Abutment Screws are indicated for use to secure a dental abutment or framework to a dental implant in the maxilla or mandible for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Subject Device NobelProcera® Titanium ASC Abutment is composed of two device lines: NobelProcera® Titanium ASC Abutment and the Clinical Screw Omnigrip Titanium.
NobelProcera® Titanium ASC Abutment is a patient matched CAD/CAM dental prosthesis which is connected to the Nobel Biocare implants featuring an internal conical and/or internal tri-channel connection, is available in the platform sizes NP, RP WP and 6.0 (for internal tri-channel connection only) and is intended for use as an aid in prosthetic rehabilitation to restore chewing function and esthetic appearance.
NobelProcera® Titanium ASC Abutments undergo patient matched customization at a Nobel Biocare production facility for the final, finished abutment device manufacturing.
NobelProcera® Titanium ASC Abutment is connected to the implant with a clinical screw and features an angulated screw channel which can be defined by the customer in an angulation (to the implant's axis) between 0° and 25°, in addition the abutment can be angulated to a maximum of 30°. The clinical screw features the Omnigrip Interface which allows tightening up to 25°.
NobelProcera® Titanium ASC Abutment and Omnigrip Clinical Screw Titanium are composed of titanium vanadium alloy Ti6Al4V ELI (ISO 5832-3, ASTM F136) and the surface of the abutments are provided with and without anodization and the Omnigrip Clinical Screw Titanium are provided with and without DLC coating.
The finished NobelProcera® Titanium ASC Abutment supports the placement of a cement-retained dental prosthesis.
Omnigrip Clinical Screw Titanium is available for the NP, RP, WP and 6.0 (for internal tri-channel connection only) platform, the devices connect the NobelProcera Titanium ASC Abutments to the dental implants. The devices feature an Omnigrip interface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla or mandible
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)
Non-clinical testing was performed on the Subject Device lines NobelProcera® Titanium ASC Abutment and Omnigrip Clinical Screw Titanium:
- Packaging system performance testing per ASTM D4169
- Dynamic loading testing performed according to ISO 14801 was conducted according to ISO 14801 and the FDA Guidance Document entitled, "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (May 12, 2004)
- Magnetic Resonance compatibility testing according to ASTM F2052, ASTM F2213, ASTM F2119 and ASTM F2182. There are no significant changes to the materials and dimensions from the currently marketed Predicate Devices. Therefore, no new issues of electromagnetic compatibility are raised for the Subject Devices and they can be considered MR Conditional. The Subject Devices have obtained the status of MR Conditional per K212125. The MR Conditional tests were conducted according to FDA's Guidance "Testing and Labeling Medical Devices for Safety in Magnetic Resonance (MR) Environment".
- Verification of biocompatibility of the final device in accordance with ISO 10993-1. The Subject Devices are equivalent in material, surface, manufacturing processes, sterilization process, body contact and contact duration to the Reference Devices per K072570, K133731, K170135, K223677 therefore, no new issues reqarding biocompatibility were raised.
- End user cleaning and sterilization validation in in accordance with ISO 17665-1
Clinical performance data is not required to establish substantial equivalence for the Subject 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.
K132746, K221301, K211109, K133731, K223677, K072570, K170135, K212125
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 24, 2024
Nobel Biocare AB Bernice Jim Head of RA Product Development and Marketed Products Vastra Hamngatan 1 Goteborg 411 17 SWEDEN
Re: K233208
Trade/Device Name: NobelProcera® Titanium ASC Abutment, Omnigrip Clinical Screw Titanium Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: September 28, 2023 Received: December 20, 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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
3
For comprehensive regulatory information about medical devices and radiation-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 Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
NobelProcera Titanium® ASC Abutments; Omnigrip Clinical Screw Titanium
Indications for Use (Describe)
NobelProcera® Titanium ASC Abutments:
NobelProcera® Abutment Titanium is a patient-matched CAD/CAM prosthetic component directly connected to endosseous dental implants and is indicated for use as an aid in prosthetic rehabilitation.
Omnigrip Clinical Screw Titanium:
Clinical and Abutment Screws are indicated for use to secure a dental abutment or framework to a dental implant in the maxilla or mandible for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation.
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)
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Image /page/4/Picture/0 description: The image contains the logo for Nobel Biocare. The logo consists of a stylized red letter "N" enclosed in a square, followed by the words "Nobel Biocare" in black text. The word "Nobel" is placed above the word "Biocare", and there is a trademark symbol after the word "Biocare".
1 – 510(k) Summary – K233208
1.1 Submitter Information
- Nobel Biocare AB Submitter: Vastra Hamngatan 1 Goteborg 411 17 Sweden
- Submitted By: Nobel Biocare Services AG Balz-Zimmerman-Strasse 7 8302 Kloten Switzerland
| Contact Person: | Bernice Jim, Ph.D |
|---|---|
| E-Mail: | regulatory.affairs.nb@envistaco.com |
| Telephone Number: | +41 43 211 42 00 |
| Prepared By: | Nicole Fuchs, MLaw |
| Date Prepared: | January 24th, 2024 |
1.2 Device Name No. 1
| Proprietary name: | NobelProcera® Titanium ASC Abutment |
|---|---|
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | II |
| Product Code: | NHA |
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Image /page/5/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a red square with a stylized white "N" inside of it. To the right of the square is the text "Nobel Biocare" in black font, with the "TM" symbol in superscript.
1.3 Device Name No. 2
| Proprietary name: | Omnigrip Clinical Screw Titanium |
|---|---|
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Abutment Screw |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | II |
| Product Code: | NHA |
1.4 Predicate Device
Primary Predicate Device No 1
| Proprietary name: | NobelProcera® Abutment Titanium (K091756) |
|---|---|
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | II |
| Product Code: | NHA |
Reference 1 for No. 1 Device
| Proprietary name: | NobelProcera Angulated Screw Channel Abutment Conica
Connection (K132746) |
|----------------------|------------------------------------------------------------------------------|
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | II |
| Product Code: | NHA |
Reference 2 for No. 1 Device
| Proprietary name: | DESS® Dental Smart Solutions (K221301) |
|---|---|
| Manufacturer: | Terrats Medical SL |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | II |
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Image /page/6/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 black font. The word "Nobel" is on the top line, and "Biocare" is on the bottom line with a trademark symbol.
Product Code:
Reference 3 for No. 1 Device
| Proprietary name: | Universal Abutment NB N1 TCC (K211109) |
|---|---|
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | II |
| Product Code: | NHA. PNP |
NHA, PNP
Reference 4 for No. 1 Device
| Proprietary name: | NOBELACTIVE WIDE PLATFORM (WP) (K133731) |
|---|---|
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | II |
| Product Code: | NHA |
Reference 5 for No. 1 Device
| Proprietary name: | Titanium Abutment Blank Nobel Biocare N1 TM TCC
(K223677) |
|----------------------|--------------------------------------------------------------|
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR§872.3630 |
| Device Class: | II |
| Product Code: | NHA, PNP |
Predicate No. 2 Device
| Proprietary name: | Omnigrip Clinical Screw CC (K132746) |
|---|---|
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | II |
| Product Code: | NHA |
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Image /page/7/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 Biocare" in black text on the right. The word "Nobel" is on the top line, and the word "Biocare" is on the bottom line with a trademark symbol.
Reference 1 for No. 2 Device
| Proprietary name: | NOBELACTIVE MULTI UNIT ABUTMENT (K072570) |
|---|---|
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | II |
| Product Code: | NHA |
Reference 2 for No. 2 Device
| Proprietary name: | Trefoil System (K170135) |
|---|---|
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | II |
| Product Code: | NHA |
Reference for No. 1 Device & No. 2 Device
| Proprietary name: | Nobel Biocare Dental Implant Systems Portfolio – MR
Conditional (K212125) |
|----------------------|------------------------------------------------------------------------------|
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Implants |
| Classification Name: | Endosseous Dental Implant and Abutment |
| Regulation Number: | 21 CFR 872.3640, 21 CFR 872.3630, 21 CFR 872.4120 |
| Device Class: | II |
| Product Code: | DZE, NHA, PNP, DZI |
1.5 Device Description Summary
The Subject Device NobelProcera® Titanium ASC Abutment is composed of two device lines: NobelProcera® Titanium ASC Abutment and the Clinical Screw Omnigrip Titanium.
NobelProcera® Titanium ASC Abutment is a patient matched CAD/CAM dental prosthesis which is connected to the Nobel Biocare implants featuring an internal conical and/or internal tri-channel connection, is available in the platform sizes NP, RP WP and
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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" in black. The word "Nobel" is on the top line, and the word "Biocare" is on the bottom line with a trademark symbol.
6.0 (for internal tri-channel connection only) and is intended for use as an aid in prosthetic rehabilitation to restore chewing function and esthetic appearance.
NobelProcera® Titanium ASC Abutments undergo patient matched customization at a Nobel Biocare production facility for the final, finished abutment device manufacturing.
NobelProcera® Titanium ASC Abutment is connected to the implant with a clinical screw and features an angulated screw channel which can be defined by the customer in an angulation (to the implant's axis) between 0° and 25°, in addition the abutment can be angulated to a maximum of 30°. The clinical screw features the Omnigrip Interface which allows tightening up to 25°.
NobelProcera® Titanium ASC Abutment and Omnigrip Clinical Screw Titanium are composed of titanium vanadium alloy Ti6Al4V ELI (ISO 5832-3, ASTM F136) and the surface of the abutments are provided with and without anodization and the Omnigrip Clinical Screw Titanium are provided with and without DLC coating.
The finished NobelProcera® Titanium ASC Abutment supports the placement of a cement-retained dental prosthesis.
Table 1-1 outlines the restorative design specifications for the NobelProcera Titanium ASC Abutments:
| Subject Device | NobelProcera®
Titanium ASC
Abutment |
|--------------------------------------------------------------------------|-------------------------------------------|
| Maximum abutment anqulation | 30° |
| Minimum screw channel thickness (min. wall thickness) | 0.42 mm |
| Maximum abutment height from implant level | 15 mm |
| Minimum diameter | 4.4 mm |
| Maximum diameter | 16 mm |
| Minimum post height (length above the abutment collar / gingival height) | 4 mm |
| Maximum post height (length above the abutment collar / gingival height) | 14.7 mm |
| Minimum gingival margin height | 0.3 mm |
Table 1-1: Design Constraints
Omnigrip Clinical Screw Titanium is available for the NP, RP, WP and 6.0 (for internal tri-channel connection only) platform, the devices connect the NobelProcera Titanium ASC Abutments to the dental implants. The devices feature an Omnigrip interface. Table 1-2 outlines the design specifications for the Omnigrip Clinical Screw Titanium:
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Image /page/9/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a red stylized letter N on the left and the words "Nobel Biocare" on the right. The word "Nobel" is above the word "Biocare", and there is a trademark symbol after the word "Biocare".
Table 1-2: Omnigrip Clinical Screw Titanium Design Specifications
| Connection | Largest nominal diameter | Nominal total length: |
|---|---|---|
| Conical | NP: 2.3 | |
| RP/WP: 2.525 | NP: 7.325 | |
| RP/WP: 7.3 | ||
| Tri-Channel | NP: 2.465 | |
| RP/WP/6.0: 2.465 | NP: 8.315 | |
| RP/WP/6.0: 10.03 |
NobelProcera® Titanium ASC Abutment and Omnigrip Clinical Screw Titanium are compatible with Nobel Biocare implants featuring an internal conical connection (K142260, K073142, K173418 and K202344) and internal tri-channel connection (K023113).
Intended Use/Indication for Use 1.6
NobelProcera® Titanium ASC Abutments:
NobelProcera® Abutment Titanium is a patient-matched CAD/CAM prosthetic component directly connected to endosseous dental implants and is indicated for use as an aid in prosthetic rehabilitation.
Omnigrip Clinical Screw Titanium:
Clinical and Abutment Screws are indicated for use to secure a dental abutment or framework to a dental implant in the maxilla or mandible for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation.
1.7 Indications for Use Comparison
The Intended Use statement and Indications for Use statement are the same, expressed through a similar choice of words.
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Image /page/10/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a red stylized letter N on the left and the words "Nobel Biocare" on the right. The word "Nobel" is on the top line and the word "Biocare" is on the bottom line with a trademark symbol.
1.8 Technological Comparison
1.8.1 NobelProcera® Titanium ASC Abutments
Table 1-3: NobelProcera Titanium ASC Abutment Predicate and Reference Device Summary
| | Subject Device | Primary Predicate
Device | Reference Device
#1 | Reference Device
#2 | Reference Device
#3 | | |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| | NobelProcera
Titanium ASC
Abutment | NobelProcera®
Abutment Titanium | NobelProcera
Angulated Screw
Channel Abutment
Conical
Connection | DESS® Dental
Smart Solutions | Universal
Abutment NB N1
TCC | Comparison | |
| | | K091756 | K132746 | K221301 | K211109 | | |
| Manufacturer | Nobel Biocare AB | Nobel Biocare AB | Nobel Biocare AB | Terrats Medical SL | Nobel Biocare AB | | |
| Product Classification | Class II | Class II | Class II | Class II | Class II | Same as Primary Predicate | |
| Regulation Number /
Name | 21 CFR 872.3630
Endosseous Dental
Implant Abutment | 21 CFR 872.3630
Endosseous Dental
Implant Abutment | 21 CFR 872.3630
Endosseous Dental
Implant Abutment | 21 CFR 872.3630
Endosseous Dental
Implant Abutment | 21 CFR 872.3630
Endosseous Dental
Implant Abutment | Same as Primary Predicate | |
| Product Code, primary | NHA | NHA | NHA | NHA | NHA | Same as Primary Predicate | |
| Product Code,
secondary | N/A | N/A | N/A | PNP | PNP | Same as Primary Predicate | |
| Review Panel | Dental | Dental | Dental | Dental | Dental | Same as Primary Predicate | |
| Intended Use | Intended to be
finalized into a single-
unit dental prosthesis,
which is connected to
an endosseous dental
implant to restore
chewing function | Nobel Biocare's
NobelProcera®/Proce
ra® Abutment
Titanium/Zirconia is a
customized dental
abutment. The
abutment attaches
directly to the
endosseous dental
implant with a clinical
screw and provides a | Nobel Biocare's
NobelProcera®
ASC Abutment
Zirconia is a
customized dental
abutment. The
abutment is seated
and attached
directly to the
endosseous dental
implant and
provides a platform | Support of a
prosthesis to
restore chewing
function | Intended to be
connected to an
endosseous dental
implant to support
the placement of a
dental prosthesis. | Same Intended Use expressed
through a similar choice of
words. | |
| Subject Device | Primary Predicate
Device | Reference Device
#1 | Reference Device
#2 | Reference Device
#3 | Comparison | | |
| NobelProcera
Titanium ASC
Abutment | NobelProcera®
Abutment Titanium | NobelProcera
Angulated Screw
Channel Abutment
Conical
Connection | DESS® Dental
Smart Solutions | Universal
Abutment NB N1
TCC | | | |
| | K091756 | K132746 | K221301 | K211109 | | | |
| | | platform for
restoration. | for restoration. The
NobelProcera®
ASC Abutment
Zirconia is
individually
designed and
manufactured to
fulfill the clinical
need of each
patient.
The NobelProcera®
ASC Abutment
Zirconia is made out
of Zirconia and is
delivered
with a titanium
adapter and an
Omnigrip™ clinical
screw. | | | | |
| Indications for Use | NobelProcera®
Abutment Titanium is
a patient-matched
CAD/CAM prosthetic
component directly
connected to
endosseous dental
implants and is
indicated for use as
an aid in prosthetic
rehabilitation. | Nobel Biocare's
NobelProcera®/Proce
ra® Abutment
titanium/Zirconia is
indicated for the
treatment of partially
edentulous patients
requiring prosthetic
devices and/or
endosseous implants
to restore chewing
function. | The NobelProcera
Angulated Screw
Channel Abutment
Conical Connection
are
premanufactured
prosthetic
components directly
connected to
endosseous dental
implants and are
intended for use as
an aid in prosthetic
rehabilitation. | DESS Dental
Smart Solutions
abutments are
intended for dental
prosthetic
restorations. DESS
Dental Smart
Solutions
abutments are
used as an
interface between a
dental implant or
dental abutment
and a dental | Universal
abutments are
indicated to support
the placement of
single unit, screw-
retained prosthetic
restorations in the
maxilla or mandible.
The Universal
Abutment consists
of two major parts.
Specifically, the
titanium base and
mesostructure | Same Indications for Use
expressed through a similar
choice of words and adjusted to
match updated wording
according to FDA feedback in
prev. submissions (K220048). | |
| Subject Device | Primary Predicate
Device | Reference Device
#1 | Reference Device
#2 | Reference Device
#3 | | | |
| NobelProcera
Titanium ASC
Abutment | NobelProcera®
Abutment Titanium | NobelProcera
Angulated Screw
Channel Abutment
Conical
Connection | DESS® Dental
Smart Solutions | Universal
Abutment NB N1
TCC | Comparison | | |
| | K091756 | K132746 | K221301 | K211109 | | | |
| | | | restoration and will
be attached to the
implant or
abutment using a
prosthetic screw
and attached to the
dental restoration
by cementing.
All digitally
designed custom
abutments for use
with Base abutment
or Pre-milled Blank
are to be sent to a
Terrats Medical
validated milling
center for
manufacture, or to
be designed and
manufactured
according to the
digital dentistry
workflow. The
digital dentistry
workflow integrates
multiple
components: scan
files from intra-oral
and lab (desktop)
scanners, CAD
software, CAM
software, ceramic | components make
up a two-piece
abutment.
The system
integrates multiple
components of the
digital dentistry
workflow scan files
from Intra-Oral
Scanners, CAD
software, CAM
software, ceramic
material, milling
machine and
associated tooling
and accessories. | | | |
| Subject Device | Primary Predicate Device | Reference Device #1 | Reference Device #2 | Reference Device #3 | Comparison | | |
| NobelProcera
Titanium ASC
Abutment | NobelProcera®
Abutment Titanium | NobelProcera
Angulated Screw
Channel Abutment
Conical
Connection | DESS® Dental
Smart Solutions | Universal
Abutment NB N1
TCC | | | |
| | K091756 | K132746 | K221301
material, milling
machine, and
associated tooling
and accessories. | K211109 | | | |
| Technological
Characteristics | | | | | | | |
| Device Dimensions/
Design Specifications | | | | | | | |
| Minimum wall
thickness: | 0.42 mm | 0.3637mm | N/A | 0.4 mm | N/A | Similar to Primary Predicate. | |
| Platform
compatibility | Conical
Connection | NP, RP, WP | NP, RP | NP, RP | NP, RP, WP
(according to 510k
summary) | N/A | Similar to Primary Predicate.
Same as Reference Device #2 |
| | Tri
Channel
Connection | NP, RP, WP, 6.0 | NP, RP, WP, 6.0 | N/A | NP, RP, WP, 6.0
(according to 510k
summary) | N/A | Same as Primary Predicate |
| | TCC | N/A | N/A | N/A | N/A | NP, RP | Same as Primary Predicate |
| Minimum
platform
diameter | NP CC | $Ø$ 3.13 | $Ø$ 3.06 | $Ø$ 3.89 | 2.52 – 6.0 mm
(Implant Platform
dependent) | N/A | Similar to Primary Predicate and
Same as Reference Device #2 |
| | NP Tri-Chan | $Ø$ 3.53 | $Ø$ 3.53 | N/A | | N/A | Same as Primary Predicate |
| | RP CC | $Ø$ 3.46 | $Ø$ 3.46 | $Ø$ 4.29 | | N/A | Same as Primary Predicate |
| | | Subject Device | Primary Predicate
Device | Reference Device
#1 | Reference Device
#2 | Reference Device
#3 | |
| | | NobelProcera
Titanium ASC
Abutment | NobelProcera®
Abutment Titanium | NobelProcera
Angulated Screw
Channel Abutment
Conical
Connection | DESS® Dental
Smart Solutions | Universal
Abutment NB N1
TCC | Comparison |
| | | | K091756 | K132746 | K221301 | K211109 | |
| | RP Tri-
Chan | Ø 4.3 | Ø 4.3 | N/A | N/A | N/A | Same as Primary Predicate |
| | WP CC | Ø 4.486 | N/A | N/A | N/A | N/A | Similar as Primary Predicate
Same as Reference Device #2 |
| | WP Tri-
Chan | Ø 5 | Ø 5 | N/A | N/A | N/A | Same as Primary Predicate |
| | 6.0 | Ø 6 | Ø 6 | N/A | N/A | N/A | Same as Primary Predicate |
| | TCC NP | N/A | N/A | N/A | N/A | Ø4.5mm | Same as Primary Predicate |
| | TCC RP | N/A | N/A | N/A | N/A | Ø4.5mm | Same as Primary Predicate |
| Minimum gingival
height: | | 0.3 mm | N/A | N/A | 0.3 mm | N/A | Same as Reference Device #2 |
| Minimum post height:
(length above the
abutment collar /
gingival height) | | 4mm | 4mm | 4mm | 4mm | N/A | Same as Primary Predicate |
| Screw Channel | | ASC (0°-25°) | Straight (0°) | ASC (0°-25°) | N/A | Straight (0°) | Similar to predicate.
Same as Reference Device #1 |
| Abutment Shape | | Patient Specific | Patient Specific | Patient Specific | Patient Specific | Standard (bottom) /
Patient specific
(top) | Same as Primary Predicate |
| Attachment method to
implant | | Screw retained | Screw retained | Screw retained | Screw retained | Screw retained | Same as Primary Predicate |
| Prosthesis attachment
method | | Cement retained | Cement retained | Cement retained | Cement retained | Cement retained | Same as Primary Predicate |
| Restoration type | | Single-unit and multi-
unit | Single-unit and multi-
unit | Single-unit | Single-unit and
multi-unit | Single-unit | Same as Primary Predicate |
| Design features | | Pre-manufactured
implant-interface
connection,
customizable | Pre-manufactured
implant-interface
connection,
customizable | Pre-manufactured
implant-interface
connection,
customizable | N/A | Two-piece
premanufactured
abutment:
customizable
restoration and | Same as Primary Predicate |
| | Subject Device | Primary Predicate
Device | Reference Device
#1 | Reference Device
#2 | Reference Device
#3 | Comparison | |
| | NobelProcera
Titanium ASC
Abutment | NobelProcera®
Abutment Titanium | NobelProcera
Angulated Screw
Channel Abutment
Conical
Connection | DESS® Dental
Smart Solutions | Universal
Abutment NB N1
TCC | | |
| | | K091756 | K132746 | K221301 | K211109 | | |
| | cylindrical abutment
body | cylindrical abutment
body | cylindrical abutment
body | | standardized
bottom | | |
| Principle of operation/
Mechanism of action | Mechanical screw
connection | Mechanical screw
connection | Mechanical screw
connection | Mechanical screw
connection | Mechanical screw
connection | Same as Primary Predicate | |
| Maximum abutment
angulation | 30° | 20° | 0° | 30 max for Blanks | 0° | Same as Reference Device #2 | |
| Material | Titanium aluminum
vanadium alloy | Titanium aluminum
vanadium alloy | Adapter:
Titanium/vanadium
alloy | Titanium aluminum
vanadium alloy | Titanium
aluminum
vanadium alloy | Same as Primary Predicate | |
| | Ti6Al4V ELI (ISO
5832-3, ASTM F136)
MTA005 | Ti6Al4V ELI (ISO
5832-3, ASTM F136)
MTA005 | Abutment Body:
Zirconium oxide | Ti6Al4V ELI (ISO
5832-3, ASTM
F136) | Ti6Al4V ELI (ISO
5832-3, ASTM
F136) | Same as Primary Predicate | |
| Surface Treatment | Anodization (Golden
Abutment) &
N/A (Non-Anodized
Abutment) | N/A | N/A | N/A | Anodization | Same as Reference Device #3 | |
| Equipment for digital
design workflow | | | | | | | |
| Design Worfkflow | Wax-up or CAD. | Wax-up or CAD. | N/A | 3Shape Intraoral
scanner Trios
series, 3Shape E-
series and
D/R2000 Lab
Scanner, 3Shape
Abutment Designer
Software (3Shape
A/S) K151455 | Scanner
Kavo LS3.
3Shape Trios or
other scanners
with equal or
higher accuracy
than 6.9 µm
Design software
DTX Studio
Design (K181932,
where the implant
libraries are | Same as Primary Predicate | |
| | Subject Device | Primary Predicate
Device | Reference Device
#1 | Reference Device
#2 | Reference Device
#3 | | |
| | NobelProcera
Titanium ASC
Abutment | NobelProcera®
Abutment Titanium | NobelProcera
Angulated Screw
Channel Abutment
Conical
Connection | DESS® Dental
Smart Solutions | Universal
Abutment NB N1
TCC | Comparison | |
| | | K091756 | K132746 | K221301 | K211109 | | |
| | | | | | automatically
included in the
software installer)
or 3Shape
Abutment
Designer Software
(K151455, where
the implant
libraries are
obtained via the
3Shape server in
the software). | | |
| Manufacturing
Workflow | Customization milled
at device
manufacturer. | Customization milled
at device
manufacturer. | N/A | Digital Dentistry
Workflow &
Validated Milling
Center | Milling unit
- Indicated for
Zirconia milling - Minimum 5 axis
milling technology - Minimum 30.000
rpm spindle speed | Same as Primary Predicate | |
11
Image /page/11/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 is the text "Nobel Biocare™" in black. The "™" symbol is in superscript.
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 is the text "Nobel Biocare™" in black. The "™" symbol is in superscript.
13
Image /page/13/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 is the text "Nobel Biocare™" in black. The word "Nobel" is on the top line and "Biocare™" is on the bottom line.
14
Image /page/14/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 is the text "Nobel Biocare™" in black. The word "Nobel" is on the top line and "Biocare™" is on the bottom line.
15
Image /page/15/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 is the text "Nobel Biocare™" in black. The "™" symbol is in superscript.
16
Image /page/16/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a red stylized letter "N" on the left and the words "Nobel Biocare" on the right. The word "Nobel" is above the word "Biocare", and there is a trademark symbol after the word "Biocare".
The similarities between the Subject Device line NobelProcera® Titanium ASC Abutments and the Primary Predicate Device are as follows:
- The design methods, manufacturing and packaging, compatible Implant/Abutment connection (CC and Tri-Ch) and platforms । (NP/RP/WP/6.0) and utilized materials are identical for the Subject and Predicate Device.
17
Image /page/17/Picture/0 description: The image shows the logo for Nobel Biocare. On the left is a red square with a stylized white "N" inside. To the right of the square is the text "Nobel Biocare" in black. The word "Nobel" is on top of the word "Biocare", and there is a trademark symbol after the word "Biocare".
- The Indications for Use of the Subject Device and the Primary Predicate Device is the same and expressed through a similar l choice of words.
- Both the Subject Device and the Primary Predicate Device are labelled MR Conditional l
Details of the Differences Between the Subject and Predicate Device:
There are no significant differences between the Subject and Predicate Devices but there are minor differences as follows:
- The minimum platform dimensions for the Connection NP platform is different in the Subject and Predicate Device, however, the minimum device dimensions are within the range of the Predicate Device and Reference Device.
- The Subject Device has a maximum angulation of 30°, identical to Reference Device #2, whereas the Predicate Device has a maximum angulation of 20°.
- The Subject Device features an anqulated screw channel, whereas the Predicate Device features a straight screw channel. This difference does not affect the shared intended use, between the devices as demonstrated by non-clinical testing. The same screw channel angulation (0° - 25°) is used for the Reference Device #1.
- The minimal wall thickness and gingival height of the Subject Device are similar and slightly greater than the Predicate Device.
- The Subject Device is provided with and without surface anodization, whereas the Predicate is not treated. The surface treated Subject Device features the same anodization already cleared in K211109.
Conclusion:
Based on a comparison of intended use, indications for use, technological characteristics, principle of operation, features, and performance data, NobelProcera® Titanium ASC Abutments is deemed to be substantially equivalent to the Primary Predicate Device as it satisfies all criteria of substantial equivalence and does not raise new concerns regarding substantial equivalence: Indications for Use, Technological Characteristics and Performance Data. The new device does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is substantial equivalent.
18
Image /page/18/Picture/0 description: The image shows the logo for Nobel Biocare. On the left is a red square with a stylized white "N" inside. To the right of the square is the text "Nobel Biocare" in black. The word "Nobel" is on top of the word "Biocare", and there is a trademark symbol after the word "Biocare".
1.8.2 Omnigrip Clinical Screw Titanium
Table 1-4: Omnigrip Clinical Screw Titanium Predicate and Reference Device Summary
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Omnigrip Clinical Screw Titanium CC NP | |||
| Omnigrip Clinical Screw Titanium CC RP/WP | |||
| Omnigrip Clinical Screw Titanium Tri-Channel NP | |||
| Omnigrip Clinical Screw Titanium Tri-Channel RP/WP/6.0 | Omnigrip Clinical Screw CC | ||
| NP/RP/WP | |||
| K132746 | |||
| Manufacturer | Nobel Biocare AB | Nobel Biocare AB | Same as Predicate |
| Product Classification | Class II | Class II | Same as Predicate |
| Regulation Number / Name | 21 CFR 872.3630 | 21 CFR 872.3630 | Same as Predicate |
| Name | Endosseous Dental Implant Abutment | Endosseous Dental Implant Abutment | Same as Predicate |
| Product Code, primary | NHA | NHA | Same as Predicate |
| Product Code, secondary | N/A | N/A | Same as Predicate |
| Review Panel | Dental | Dental | Same as Predicate |
| Intended Use | Intended for use to fasten dental implant system components to a dental implant or to another component. | Intended for use to fasten dental implant system components to a dental implant or to another component. | Same as Predicate |
| Indications for Use | Clinical and Abutment Screws are indicated for use to secure a dental abutment or framework to a dental implant in the maxilla or mandible for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation. | Clinical Screws are indicated for use to secure a dental abutment or framework to a dental implant in the maxilla or mandible for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation. | Same as Predicate |
| Technological Characteristics | |||
| Device Dimensions/ Design Specifications | |||
| Screw body dimensions | Largest nominal diameter: | ||
| CC NP: 2.3 | |||
| CC RP/WP: 2.525 | Largest nominal diameter: | ||
| NP: 2.375 mm | |||
| RP: 2.525 mm | Similar as Predicate | ||
| TriCh NP: 2.465 | |||
| TriCh RP/WP/6.0: 2.465 | |||
| Nominal total length: | |||
| CC NP: 7.325 | |||
| CC RP/WP: 7.3 |
TriCh NP: 8.315
TriCh RP/WP/6.0: 10.03 | Nominal total length:
NP: 8.905 mm
RP: 8.705 mm | |
| Compatible implant
platform sizes | Narrow Platform (NP)
Regular Platform (RP)
Wide Platform (WP)
6.0 | Narrow Platform (NP)
Regular Platform (RP)
Wide Platform (WP) | Same as Predicate |
| Screw Interface | OmniGrip | OmniGrip | Same as Predicate |
| Principle of operation/
(Attachment method) | The Omnigrip clinical screws are used for
securing the abutment to the endosseous implant. | The Omnigrip clinical screws are
used for securing the abutment to the
endosseous implant. | Same as Predicate |
| Material | Titanium vanadium alloy
MTA 005
(Ti6Al4V ELI, ASTM F136-13 / ISO 5832)" | Titanium vanadium alloy
MTA 005
(Ti6Al4V ELI, ASTM F136-13 / ISO
5832)" | Same as Predicate |
| Surface material | CC & TriCh NP: N/A (machined surface, no PVD
(DLC) coating)
CC RP/WP &: TriCh RP/WP/6.0: PVD (DLC)
surface treatment | NP: N/A (machined surface, no PVD
(DLC) coating) ,Blue anodization on
screw head
RP/WP: PVD (DLC) surface
treatment
Blue anodization on screw head" | Similar as Predicate |
19
Image /page/19/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a red stylized letter N on the left and the words "Nobel Biocare" on the right. The word "Nobel" is above the word "Biocare", and there is a trademark symbol after the word "Biocare".
The similarities between the Omnigrip Clinical Screw Titanium and the Predicate Device Omnigrip Clinical Screw CC NP/RP/WP are as follows:
- The Intended Use, Indications for Use, the Principle of operation, device material, compatible implant platform, thread । design and screw interfaces are the same for both, Subject Device and the Predicate Devices are used to
20
Image /page/20/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a red square with a stylized "N" inside of it on the left. To the right of the square is the text "Nobel Biocare" in black. The word "Nobel" is on top of the word "Biocare", and there is a trademark symbol after the word "Biocare".
fix a prosthetic component to a dental abutment. Furthermore, both, the Subject and Predicate Device are non-sterile, single-use devices.
Details of the Differences Between the Subject and Predicate Device:
There are no significant differences between the Subject and Predicate Devices but there are minor differences as follows:
- Both devices, Subject Device and Predicate Device, are provided with and without DLC (Diamond like carbon) coating, however, the screw head of the Subject Device is not anodized in comparison to the Predicate device.
- The Subject Device and Predicate Device have different screw body dimensions. ।
- The compatible abutment platforms of the Subject Device features either a conical connection (CC) or a Tri-Channel । Connection (Tri-Ch) whereas the Predicate Device features a conical connection (CC).
Conclusion:
Based on a comparison of intended use, indications for use, technological characteristics, principle of operation, features, and performance data, Omnigrip Clinical Screw Titanium is deemed to the Primary Predicate Device as it satisfies all criteria of substantial equivalence and does not raise new concerns regarding substantial equivalence: Indications for Use, Technological Characteristics and Performance Data. The new device does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is substantial equivalent.
21
Image /page/21/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 word "Nobel" is in a larger, bolder font than "Biocare", and the trademark symbol is next to the word "Biocare".
Non-Clinical and/or Clinical Tests Summary & Conclusions: 1.9
Non-clinical testing was performed on the Subject Device lines NobelProcera® Titanium ASC Abutment and Omnigrip Clinical Screw Titanium:
- Packaging system performance testing per ASTM D4169
- . Dynamic loading testing performed according to ISO 14801 was conducted according to ISO 14801 and the FDA Guidance Document entitled, "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (May 12, 2004)
- . Magnetic Resonance compatibility testing according to ASTM F2052, ASTM F2213, ASTM F2119 and ASTM F2182. There are no significant changes to the materials and dimensions from the currently marketed Predicate Devices. Therefore, no new issues of electromagnetic compatibility are raised for the Subject Devices and they can be considered MR Conditional. The Subject Devices have obtained the status of MR Conditional per K212125. The MR Conditional tests were conducted according to FDA's Guidance "Testing and Labeling Medical Devices for Safety in Magnetic Resonance (MR) Environment".
- Verification of biocompatibility of the final device in accordance with ISO 10993-1. The Subject Devices are equivalent in material, surface, manufacturing processes, sterilization process, body contact and contact duration to the Reference Devices per K072570, K133731, K170135, K223677 therefore, no new issues reqarding biocompatibility were raised.
- End user cleaning and sterilization validation in in accordance with ISO 17665-1 ●
Clinical performance data is not required to establish substantial equivalence for the Subject Devices.
Based on a comparison of intended use, indications, material composition, technological characteristics, principle of operation, features and performance data, the two device lines NobelProcera® Titanium ASC Abutment and Omnigrip Clinical Screw Titanium are deemed to be substantially equivalent to the Predicate Devices.