(113 days)
No
The summary describes a physical dental healing abutment and its materials, sterilization, and testing, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is described as an accessory to dental implants, designed to facilitate gingival tissue healing. It does not actively treat a disease or medical condition.
No
This device is designed to facilitate gingival tissue healing, not to diagnose a condition.
No
The device description clearly states it is a two-piece healing abutment made of Titanium Alloy, indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the BellaTek Encode Emergence Healing Abutments are used as an accessory to dental implants during healing to prepare gingival tissue. This is a direct interaction with the patient's body for a therapeutic purpose (facilitating healing and tissue preparation).
- Device Description: The description details a physical implant component made of titanium alloy, designed to be placed in the mouth.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device does none of those things.
The information provided describes a medical device used in vivo (within the body) for a therapeutic and preparatory purpose related to dental implants.
N/A
Intended Use / Indications for Use
The BellaTek Encode Emergence Healing Abutments are intended for use as an accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tissue for acceptance of a final abutment and restoration.
Product codes
NHA
Device Description
The BellaTek Encode Emergence Healing Abutment is a two-piece healing abutment (abutment with a retaining screw) designed to facilitate gingival tissue healing before a final restoration is placed. It consists of an abutment and a retaining screw that are assembled and packaged together and provided sterile. Both components are machined from Titanium Alloy Ti-6Al-4V ELI (ASTM F136). They are available in pre-defined diameters, emergence profiles and heights to accommodate varying patient anatomies. The shelf life of the TSV BellaTek Encode Healing Abutment is 5 years from the date of manufacture and they are intended for single use only. The device is packaged in a blister tray with Tyvek Lid and sold sterile. The device is sterilized using the gamma irradiation method. The BellaTek Encode Emergence Healing Abutments are color anodized for aesthetic purposes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical testing data submitted or relied upon to demonstrate substantial equivalence included radiation sterilization validation according to ISO 11137-2, demonstration a sterility assurance level (SAL) of 106, biological evaluation according to ISO 10993-1 demonstrating acceptable biocompatibility and accelerated and real time aging studies by reference to K173374 demonstrating a shelf life of five years.
The subject devices have less surface area and are made out of same materials as compared to previously tested Biomet 3i devices that were used for MR compatibility testing. Hence the MR testing data is leveraged and the subject devices are labeled as MR conditional.
Risk analysis was conducted in accordance to ISO 14971 to evaluate the effect of the modifications on the subject device. The changes in design from the predicate devices have been verified through biocompatibility evaluation, MRI compatibility assessment and design validation study. The changes to the subject device do not identify new risks. nor do the changes impact the risk profile of the device compared to the predicate devices. Revised labeling was provided to ensure proper placement of the device due to differences in emergence profile. Design control activities conclude that the differences between the predicate and the subject device do not impact the substantial equivalence of the product. In addition, confirmatory cytotoxicity testing was performed via ISO 10993-5, which also demonstrated substantial equivalence.
No clinical data were included in this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). 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.
Biomet 3i LLC Krupal Patel Principal Regulatory Specialist 4555 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K212730
Trade/Device Name: BellaTek Encode Emergence Healing Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: November 19, 2021 Received: November 22, 2021
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.
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): K212730
Device Name: BellaTek Encode Emergence Healing Abutments
Indications for Use:
The BellaTek Encode Emergence Healing Abutments are intended for use as an accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tissue for acceptance of a final abutment and restoration.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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
BellaTek Encode Emergence Healing Abutments 510(k) Summary K212730 12/21/2021
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 LLC |
|---|---|
| Address: | 4555 Riverside Drive |
| Palm Beach Gardens, Florida 33410 | |
| Phone: | (561) 776-6923 |
| Fax: | (561) 514-6316 |
Contact Person: Krupal Patel Job Title: Principal Regulatory Specialist Email: krupal.patel(@zimmerbiomet.com
- II. Proprietary Trade Name: BellaTek Encode Emergence Healing Abutments
- III. Device Classification Name: Endosseous Dental Implant Abutment (21 CFR 872.3630)
- IV. Regulatory Class: Class II
- V. Product Code: NHA
Predicate Devices: VI.
Primary predicate device:
-
. TSV BellaTek Encode Healing Abutments (K173374)
Reference device: -
. Eztetic BellaTek Encode Healing Abutments (K170013)
-
Certain BellaTek Encode Healing Abutments and Certain EP Healing Abutments referenced in Biomet 3i Dental Abutments and Restorative Components (K072642)
VII. Product Description:
The BellaTek Encode Emergence Healing Abutment is a two-piece healing abutment (abutment with a retaining screw) designed to facilitate gingival tissue healing before a final restoration is placed. It consists of an abutment and a retaining screw that are assembled and packaged together and provided sterile. Both components are machined from Titanium Alloy Ti-6Al-4V ELI
4
(ASTM F136). They are available in pre-defined diameters, emergence profiles and heights to accommodate varying patient anatomies. The shelf life of the TSV BellaTek Encode Healing Abutment is 5 years from the date of manufacture and they are intended for single use only. The device is packaged in a blister tray with Tyvek Lid and sold sterile. The device is sterilized using the gamma irradiation method. The BellaTek Encode Emergence Healing Abutments are color anodized for aesthetic purposes.
Indications for Use: VIII.
The BellaTek Encode Emergence Healing Abutments are intended for use as an accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tissue for acceptance of a final abutment and restoration.
IX. Summary of the Technological Characteristics:
The BellaTek Encode Emergence Healing Abutments are designed to aid in soft tissue contouring during the healing period after implant placement, creating an emergence profile for the final prosthesis. They have the added design feature of machined markings for identification when taking an abutment level impression or an intraoral scan/digital impression. Identification and orientation information is captured in the intraoral scan or model scan.
The BellaTek Encode Emergence Healing Abutments consist of three variations differing primarily on the implant connection: TSV BellaTek Encode Emergence Healing Abutments, Eztetic BellaTek Encode Emergence Healing Abutments, and Certain BellaTek Encode Emergence Healing Abutments. The retaining screw is used to secure the abutment to the implant. The subject device seats on the lead-in bevel (TSV and Eztetic) or the seating surface (Certain) of the implant connection. A substantial equivalence comparison of subject and predicate device is provided in Table 1.
The BellaTek Encode Emergence Healing Abutments and retaining screws are color anodized pink for improved aesthetics. The primary predicate device does not have color anodization, however the reference device in K072642 does have color anodization in a manner similar to the subject devices. The landmark pattern on the occlusal surface of the BellaTek Encode Emergence Healing Abutments represents a simplified "code scheme" that achieves same functionality as the predicate device. The BellaTek Encode Emergence Healing Abutments are offered in additional emergence profiles and slightly different abutment heights to accommodate varying patient anatomy as compared to the predicate device. Risk Analysis was conducted in accordance to ISO 14971 to evaluate the effect of the modifications on the subject device. The Biocompatibility evaluation, MRI assessment and Design Validation studies have shown that the device changes, including emergence profile sizes, full color anodization and machined marking designs, do not raise new risks and it concludes that the differences between the predicate and the subject device do not impact the substantial equivalence of the product.
5
| Feature | Subject Device
BellaTek Encode
Emergence Healing
Abutment | Primary Predicate
TSV BellaTek
Encode Healing
Abutment
(K173374) | Reference Device 1
Eztetic BellaTek
Encode Healing
Abutment
(K170013) | Reference Device 2
Certain BellaTek
Encode Healing
Abutment & Certain
EP Healing
Abutment
(K072642) |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/
Indications for
Use | The BellaTek
Encode Emergence
Healing Abutments
are intended for use
as an accessory to
endosseous dental
implants during
endosseous and
gingival healing to
prepare gingival
tissue for acceptance
of a final abutment
and restoration. | The TSV BellaTek
Encode Healing
Abutments are
intended for use as
an accessory to
endosseous dental
implants during
endosseous and
gingival healing to
prepare gingival
tissue for
acceptance of a
final abutment and
restoration. | The Eztetic
BellaTek Encode
Healing Abutments
are intended for use
as an accessory to
endosseous dental
implants during
endosseous and
gingival healing to
prepare gingival
tissue for acceptance
of a final abutment
and restoration. | Biomet 3i Dental
Abutments are
intended 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.
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 prosthetics.
• Screw |
6
| Feature | Subject Device
BellaTek Encode
Emergence Healing
Abutment | Primary Predicate
TSV BellaTek
Encode Healing
Abutment
(K173374) | Reference Device 1
Eztetic BellaTek
Encode Healing
Abutment
(K170013) | Reference Device 2
Certain BellaTek
Encode Healing
Abutment & Certain
EP Healing
Abutment
(K072642) |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating
Principle | The BellaTek
Encode Emergence
Healing Abutment
aids in prosthetic
rehabilitation by
supporting the
surrounding gingival
tissue during the
healing period. The
healing abutment is
fixated on the
implant using a
retaining screw
immediately after
implant placement in
a one-stage surgical
protocol. In a two-
stage surgical
protocol, the healing
abutment is fixated
on the implant
following the bone
healing period. The
soft tissue is sutured
around the healing
abutment and the
device remains in the
mouth until the soft
tissue fully develops. | The TSV BellaTek
Encode Healing
Abutment aids in
prosthetic
rehabilitation by
supporting the
surrounding
gingival tissue
during the healing
period. The healing
abutment is fixated
on the implant
using a retaining
screw immediately
after implant
placement in a one-
stage surgical
protocol. In a two-
stage surgical
protocol, the
healing abutment is
fixated on the
implant following
the bone healing
period. The soft
tissue is sutured
around the healing
abutment and the
device remains in
the mouth until the
soft tissue fully
develops. | The Eztetic
BellaTek Encode
Healing Abutment
aids in prosthetic
rehabilitation by
supporting the
surrounding gingival
tissue during the
healing period. The
healing abutment is
fixated on the
implant using a
retaining screw
immediately after
implant placement
in a one-stage
surgical protocol. In
a two-stage surgical
protocol, the healing
abutment is fixated
on the implant
following the bone
healing period. The
soft tissue is sutured
around the healing
abutment and the
device remains in
the mouth until the
soft tissue fully
develops. | components are
intended for use
as accessories to
endosseous dental
implants for
retention of screw
retained
abutments to the
dental implant.
The Certain
BellaTek Encode
Healing Abutment
aids in prosthetic
rehabilitation by
supporting the
surrounding gingival
tissue during the
healing period. The
healing abutment is
fixated on the
implant using a
retaining screw
immediately after
implant placement in
a one-stage surgical
protocol. In a two-
stage surgical
protocol, the healing
abutment is fixated
on the implant
following the bone
healing period. The
soft tissue is sutured
around the healing
abutment and the
device remains in the
mouth until the soft
tissue fully develops. |
7
| Feature | Subject Device
BellaTek Encode
Emergence Healing
Abutment | Primary Predicate
TSV BellaTek
Encode Healing
Abutment
(K173374) | Reference Device 1
Eztetic BellaTek
Encode Healing
Abutment
(K170013) | Reference Device 2
Certain BellaTek
Encode Healing
Abutment & Certain
EP Healing
Abutment
(K072642) |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Identification | Scheme
(Machined
Markings) | Scheme
(Machined
Markings) | Scheme
(Machined
Markings) | Scheme
(Machined
Markings) |
| Emergence
Profile (mm) | TSV Abutments:
3.8, 4.5, 5.0, 5.5, 5.7,
6.5, 6.8 and 7.5
Eztetic Abutments:
3.7 and 4.5
Certain Abutments:
3.8, 4.1, 5.0, 6.0, 6.8
and 7.5 | 3.8, 5.0, 5.6, 6.0
and 6.8 | 3.8 and 5.0 | 3.8, 4.1, 5.0, 5.6, 6.0,
6.8 and 7.5 |
| Abutment
Height (mm) | TSV Abutments:
3.0, 5.0 and 7.0
Eztetic Abutments:
3.0, 5.0 and 7.0
Certain Abutments:
3.0, 5.0 and 7.0 | 3.0, 5.0 and 7.0 | 3.0, 4.0, 6.0 and 8.0 | 3.0, 4.0, 6.0 and 8.0 |
| Restorative
Platform
Diameter (mm) | TSV Abutments:
3.5, 4.5 and 5.7
Eztetic Abutments:
2.9
Certain Abutments:
3.4, 4.1, 5.0 and 6.0 | 3.5, 4.5. 5.7 | 2.9 | 3.4, 4.1, 5.0 and 6.0 |
| Mating Implant | TSV Abutments:
Zimmer Dental TSV
Dental Implant
System
Eztetic Abutments:
Zimmer Dental
Eztetic Dental
Implant System
Certain Abutments:
Biomet 3i Certain
(Internal Hex) Dental
Implant System | Zimmer Dental
TSV Dental
Implant System | Zimmer Dental
Eztetic Dental
Implant System | Biomet 3i Certain
(Internal Hex)
Dental Implant
System |
| Color
Anodization | Pink color
anodization | None | None | Certain EP Healing
Abutment include
color anodized
surfaces |
| Abutment and
Screw Material | Titanium Alloy
(Ti-6Al-4V ELI) | Titanium Alloy
(Ti-6Al-4V ELI) | Titanium Alloy
(Ti-6Al-4V ELI) | Titanium Alloy
(Ti-6Al-4V ELI) |
| Packaging | Bubble Tray
packaging
configuration | Bubble Tray
packaging
configuration | Bubble Tray
packaging
configuration | Bubble Tray
packaging
configuration |
| Sterilization | Supplied Sterile | Supplied Sterile | Supplied Sterile | Supplied Sterile |
8
| Feature | Subject Device
BellaTek Encode
Emergence Healing
Abutment | Primary Predicate
TSV BellaTek
Encode Healing
Abutment
(K173374) | Reference Device 1
Eztetic BellaTek
Encode Healing
Abutment
(K170013) | Reference Device 2
Certain BellaTek
Encode Healing
Abutment & Certain
EP Healing
Abutment
(K072642) |
|------------|--------------------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Method | (Gamma radiation) | (Gamma radiation) | (Gamma radiation) | (Gamma radiation) |
| Shelf Life | 5 years | 5 years | 5 years | 5 years |
| Single Use | Yes | Yes | Yes | Yes |
X. Non-Clinical Testing:
Non-clinical testing data submitted or relied upon to demonstrate substantial equivalence included radiation sterilization validation according to ISO 11137-2, demonstration a sterility assurance level (SAL) of 106, biological evaluation according to ISO 10993-1 demonstrating acceptable biocompatibility and accelerated and real time aging studies by reference to K173374 demonstrating a shelf life of five years.
The subject devices have less surface area and are made out of same materials as compared to previously tested Biomet 3i devices that were used for MR compatibility testing. Hence the MR testing data is leveraged and the subject devices are labeled as MR conditional.
Risk analysis was conducted in accordance to ISO 14971 to evaluate the effect of the modifications on the subject device. The changes in design from the predicate devices have been verified through biocompatibility evaluation, MRI compatibility assessment and design validation study. The changes to the subject device do not identify new risks. nor do the changes impact the risk profile of the device compared to the predicate devices. Revised labeling was provided to ensure proper placement of the device due to differences in emergence profile. Design control activities conclude that the differences between the predicate and the subject device do not impact the substantial equivalence of the product. In addition, confirmatory cytotoxicity testing was performed via ISO 10993-5, which also demonstrated substantial equivalence.
No clinical data were included in this submission.
XI. Conclusion:
The subject devices have demonstrated substantial equivalence to the predicate devices in that they utilize same materials and fundamental designs and also have the same intended use and principles of operation.