(231 days)
No
The summary describes a dental abutment and its manufacturing process, which involves CAD/CAM design and milling. There is no mention of AI or ML being used in the design, manufacturing, or intended use of the device.
No.
The device is an accessory to dental implants, intended to support a prosthetic device, not to provide therapy.
No
Explanation: The device description states that the BellaTek® Express and BellaTek® Flex Abutments are "Titanium-base type abutments to be used as the apical part of two-piece abutments" to support a prosthetic device. There is no indication that this device is used for diagnosis; rather, it is a component for dental restoration.
No
The device description clearly states the device is a Titanium-base type abutment, which is a physical hardware component. The summary also describes manufacturing processes and materials for physical parts.
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 Description: The description clearly states that the BellaTek Abutments are accessories to endosseous dental implants used to support prosthetic devices in the mouth (mandible or maxilla). They are physical components implanted into the bone.
- Intended Use: The intended use is to support dental prosthetics, not to perform diagnostic tests on biological samples.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, diagnostic purposes, or any of the typical components or processes associated with IVD devices (reagents, analyzers, test results, etc.).
Therefore, the BellaTek Abutments are medical devices, specifically dental implant abutments, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Certain BellaTek® Express and BellaTek® Flex Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained.
All digitally designed superstructures and/or hybrid abutment crowns for use with Certain BellaTek Express or BellaTek Flex Abutments are intended to be sent to a Biomet 3i validated milling center for manufacture.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Certain BellaTek Express Abutment and BellaTek Flex Abutment (subject devices) are Titanium-base type abutments to be used as the apical part of two-piece abutments. The coronal part of the two-piece abutment is a CAD/CAM designed and manufactured superstructure. All digitally designed superstructures manufactured in zirconia conform to ISO 13356:2015 and ISO 6872:2015. Biomet 3i recommends the use of Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436) to affix the zirconia superstructure and/or hybrid abutment crown to the Certain BellaTek Express and BellaTek Flex abutments. Certain BellaTek Express Abutment and BellaTek Flex Abutment are intended to be used with Biomet 3i Certain (Internal Hex) dental implants for single and multi-unit restorations. The subject device abutments are available in hexed (single-unit) and nonhexed (multi-unit) configurations. They are available in pre-defined platform diameters, emergence profiles and heights to accommodate varying patient anatomies. They are machined from Titanium Alloy. They are intended for single use only. The device is packaged in a sealed nylon bag and sold non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or maxilla
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 conducted per FDA Guidance Document (Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling) and steam sterilization validation according to ISO 17665-1 and ISO 17665-2. demonstrating a sterility assurance level (SAL) of 10-6 of the device. Biological evaluation was conducted in accordance with FDA Guidance Document (Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process") demonstrating acceptable biocompatibility of the device. MR testing data is leveraged and the subject device is labeled as MR conditional. Devices were designed & developed in accordance to applicable FDA Guidance Document (Guidance for Industry and FDA staff – Class II special controls guidance document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments).
No clinical data was included in this submission.
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.)
0
Image /page/0/Picture/0 description: The image contains 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 logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
July 2, 2019
Biomet 3i Krupal Patel Senior Regulatory Specialist 4555 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K183138
Trade/Device Name: Certain BellaTek® Express and BellaTek® Flex Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: June 5, 2019 Received: June 7, 2019
Dear Krupal Patel:
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 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,
for Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE
510(k) Number (if known): K183138
Device Name: Certain BellaTek® Express and BellaTek® Flex Abutments
Indications for Use:
Certain BellaTek® Express and BellaTek® Flex Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained.
All digitally designed superstructures and/or hybrid abutment crowns for use with Certain BellaTek Express or BellaTek Flex Abutments are intended to be sent to a Biomet 3i validated milling center for manufacture.
| Prescription Use | X_ |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | __________ |
|---|---|
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
Certain BellaTek® Express and BellaTek® Flex Abutments 510(k) Summary K183138 2/July/2019
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92
I. Submitter Information:
| Name: | Biomet 3i | ||
|---|---|---|---|
| Address: | 4555 Riverside Drive | ||
| Palm Beach Gardens, Florida 33410 | |||
| Phone: | (561) 776-6923 | ||
| Fax: | (561) 514-6316 | ||
| Contact Person: Krupal Patel | |||
| Job Title: | Senior Regulatory Specialist | ||
| Email: | krupal.patel@zimmerbiomet.com | ||
| II. | Proprietary Trade Name: | Certain BellaTek® Express and BellaTek® Flex Abutments | |
| III. | Device Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) | |
| IV. | Regulatory Class: | Class II | |
| V. | Product Code: | NHA | |
| VI. | Reviewing Branch: | Dental Devices Branch | |
VII. Predicate Devices:
Primary predicate device:
- GingiHue Abutments and Temporary Cylinders referenced in Biomet 3i Dental . Abutments and Restorative Components (K072642 / SE 12/20/2007)
Reference predicate device:
- Titanium-base Abutments referenced in Terrats Medical SL's DESS Dental Smart . Solutions (K170588 / SE 08/08/2017)
VIII. Indications for Use:
Certain BellaTek Express and BellaTek Flex Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple
4
tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained.
All digitally designed superstructures and/or hybrid abutment crowns for use with Certain BellaTek Express or BellaTek Flex Abutments are intended to be sent to a Biomet 3i validated milling center for manufacture.
IX. Device Description:
The Certain BellaTek Express Abutment and BellaTek Flex Abutment (subject devices) are Titanium-base type abutments to be used as the apical part of two-piece abutments. The coronal part of the two-piece abutment is a CAD/CAM designed and manufactured superstructure. All digitally designed superstructures manufactured in zirconia conform to ISO 13356:2015 and ISO 6872:2015. Biomet 3i recommends the use of Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436) to affix the zirconia superstructure and/or hybrid abutment crown to the Certain BellaTek Express and BellaTek Flex abutments. Certain BellaTek Express Abutment and BellaTek Flex Abutment are intended to be used with Biomet 3i Certain (Internal Hex) dental implants for single and multi-unit restorations. The subject device abutments are available in hexed (single-unit) and nonhexed (multi-unit) configurations. They are available in pre-defined platform diameters, emergence profiles and heights to accommodate varying patient anatomies. They are machined from Titanium Alloy. They are intended for single use only. The device is packaged in a sealed nylon bag and sold non-sterile.
X. Summary of the Technological Characteristics:
The subject devices, Certain BellaTek Express Abutment and BellaTek Flex Abutment, are Titanium-base type abutments to be used as the apical part of two-piece abutments. They feature a narrow collar for improved aesthetics, pre-grooved preparation markings for varying occlusal heights, and the screw or cement retained restoration option. Subject device abutments are available in 3.4, 4.1, 5.0 and 6.0mm platform diameters. A general device comparison of the subject and predicate devices is provided in Table 1.
The Indications for Use statement for the subject device is similar to the Indications for Use statement for the Primary Predicate Device.
GingiHue Abutments and Temporary Cvlinders cleared in K072642 are used as a primary predicate device as the design features of these devices are similar to the subject device.
| Comparison | Subject Device | Primary Predicate Device | Reference
Predicate device |
|------------|------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------|
| | Certain BellaTek Express
and BellaTek Flex
Abutments | K072642
Biomet 3i Dental Abutments &
Restorative Components | K170588
DESS Dental Smart
Solutions |
| | Biomet 3i | Biomet 3i | Terrats Medical SL |
| | Indications for
Use | Certain BellaTek Express
and BellaTek Flex | Biomet 3i Dental Abutments
are intended for use as |
Table 1: General device comparison
5
| Comparison | Subject Device | Primary Predicate Device | Reference
Predicate device |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Certain BellaTek Express
and BellaTek Flex
Abutments
Biomet 3i | K072642
Biomet 3i Dental Abutments &
Restorative Components
Biomet 3i | K170588
DESS Dental Smart
Solutions
Terrats Medical SL |
| | Abutments are intended | accessories to endosseous | are intended to be |
| | for use as accessories to
endosseous dental
implant to support a
prosthetic device in a
partially or completely
edentulous patient. A
dental abutment is
intended for use to
support single and
multiple tooth prosthesis,
in the mandible or
maxilla. The prosthesis
can be screw retained or
cement retained.
All digitally designed
superstructure and/or
hybrid abutment crowns
for use with Certain
BellaTek Express and
BellaTek Flex Abutments
are intended to be sent to
a Biomet 3i validated
milling center for
manufacture. | dental implant to support a
prosthetic device in a partially
or completely edentulous
patient. A dental abutment is
intended for use to support
single and multiple tooth
prosthesis, in the mandible or
maxilla. The prosthesis can be
screw retained or cement
retained.
Restorative Components:
• Temporary healing
abutments are intended for
use to shape and maintain
the soft tissue opening
during healing
• Castable restorative
components are intended for
use as accessories to
endosseous dental implants
to aid in the fabrication of
dental prosthesis
• Screw components are
intended for use as
accessories to endosseous
dental implants for retention
of screw retained abutments
to the dental implant | 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 TiBase or
Pre-milled Blank are
to be sent to a Terrats
Medical validated
milling center for
manufacture. |
| Intended Use | It is a device, which
attaches to the dental
implant to restore
chewing function. | It is a device, which attaches to
the dental implant to restore
chewing function. | It is a device, which
attaches to the dental
implant to restore
chewing function. |
| Design | | | |
| Platform
Diameter | 3.4, 4.1, 5.0 and 6.0mm | 3.4, 4.1, 5.0 and 6.0mm | 3.4 - 5.7mm |
| Abutment Angle | Straight | Straight to 30° | Straight |
| Prosthesis
Attachment | Screw or Cement retained | Screw or Cement retained | Screw or Cement
retained |
| Restoration | Single unit &
Multi unit | Single unit &
Multi unit | Single unit &
Multi unit |
| Implant
/Abutment
Connection | Biomet 3i Internal
Hex Implants | Biomet 3i Internal and
External Hex Implants | Biomet 3i, Nobel
Biocare, Astra Tech,
Zimmer Dental |
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| Comparison | Subject Device | Primary Predicate Device | Reference
Predicate device |
|------------|------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------|
| | Certain BellaTek Express
and BellaTek Flex
Abutments | K072642
Biomet 3i Dental Abutments &
Restorative Components | K170588
DESS Dental Smart
Solutions |
| | Biomet 3i | Biomet 3i | Terrats Medical SL |
| | | | Straumann &
Dentsply Implants |
| Material | | | |
| Abutment | Titanium Alloy
(Ti-6Al-4V ELI) and
Zirconia | Titanium Alloy
(Ti-6Al-4V ELI) &
Commercial Pure Titanium | Titanium Alloy
(Ti-6Al-4V ELI) |
Certain BellaTek Express and BellaTek Flex abutments are substantially equivalent in design, function, material, and Indications for Use to GingiHue Abutments & Titanium Temporary Cylinders referenced in Biomet 31's Dental Abutments (K072642) and Titanium-base abutments referenced in Terrats Medical SL's Dess Dental Smart Solutions (K170588). All are intended for use with endosseous dental implants in the maxilla and mandible to provide prosthetic support. All digitally designed superstructures for use with the subject device and the reference device are to be sent to a validated milling center for manufacture.
XI. Performance Data:
Non-clinical testing was conducted per FDA Guidance Document (Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling) and steam sterilization validation according to ISO 17665-1 and ISO 17665-2. demonstrating a sterility assurance level (SAL) of 10to of the device. Biological evaluation was conducted in accordance with FDA Guidance Document (Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process") demonstrating acceptable biocompatibility of the device. MR testing data is leveraged and the subject device is labeled as MR conditional. Devices were designed & developed in accordance to applicable FDA Guidance Document (Guidance for Industry and FDA staff – Class II special controls guidance document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments).
No clinical data was included in this submission.
XII. Conclusion:
The subject device has demonstrated substantial equivalence to the predicate devices in that it has the same intended use, the same operating principle, identical materials and similar fundamental design.