Who is the manufacturer of Eztetic BellaTek Encode Healing Abutments?

Biomet 3i filed the 510(k) submission for Eztetic BellaTek Encode Healing Abutments (K170013).

What is the FDA product code for Eztetic BellaTek Encode Healing Abutments?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Eztetic BellaTek Encode Healing Abutments?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Eztetic BellaTek Encode Healing Abutments?

BellaTek® Encode® Healing Abutments (K072642).

Who can help prepare an FDA 510(k) submission like Eztetic BellaTek Encode Healing Abutments?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Eztetic BellaTek Encode Healing Abutments

K170013 · Biomet 3i · NHA · Sep 21, 2017 · Dental

Device Facts

Record ID	K170013
Device Name	Eztetic BellaTek Encode Healing Abutments
Applicant	Biomet 3i
Product Code	NHA · Dental
Decision Date	Sep 21, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2

Intended Use

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.

Device Story

Healing abutment accessory for endosseous dental implants; facilitates gingival tissue healing; consists of abutment and retaining screw; machined from Ti-6Al-4V ELI titanium alloy; features Encode coding scheme (machined markings) for implant position/orientation; used in dental clinics by clinicians; fixated on implant via retaining screw in one-stage or two-stage surgical protocols; soft tissue sutured around device; remains in mouth until soft tissue development; provides passive/clearance fit within implant internal connection; supports gingival tissue preparation for final restoration.

Clinical Evidence

Bench testing only. No clinical data. Testing included torque to failure, physical fit evaluation, tolerance analysis, and print verification. Biocompatibility and MR compatibility leveraged from identical materials in previously tested Biomet 3i devices. Packaging integrity validated per ISO 11607-1 and ASTM D4169.

Technological Characteristics

Material: Titanium Alloy (Ti-6Al-4V ELI) per ASTM F136. Form: 2.9mm restorative platform, 3-8mm heights, 3.8-5mm emergence profiles. Connection: Flat-on-flat engagement with internal implant connection. Sterilization: Gamma radiation (25-38 kGy) per ISO 11137-1/2. Shelf life: 5 years. Coding: Machined markings for implant orientation.

Indications for Use

Indicated for patients requiring endosseous dental implant healing; used to prepare gingival tissue for final abutment and restoration.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

BellaTek® Encode® Healing Abutments (K072642)

Reference Devices

Healing Collars (K142082)

Related Devices

K212730 — BellaTek Encode Emergence Healing Abutments · Biomet 3i, LLC · Dec 21, 2021
K173374 — TSV BellaTek Encode Healing Abutments · Biomet 3i · Dec 13, 2017
K192893 — Straumann Ceramic Healing Abutments · Institut Straumann AG · Jan 3, 2020
K111852 — ANODIZED HEALING COLLAR · Zimmer Dental, Inc. · Aug 11, 2011
K251434 — Healing Abutment System · Osstem Implant Co., Ltd. · Mar 4, 2026

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 21, 2017 BIOMET 3i Krupal Patel Senior Regulatory Specialist 4555 Riverside Drive Palm Beach Gardens, Florida 33410 Re: K170013 Trade/Device Name: Eztetic™ BellaTek® Encode® Healing Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: September 1, 2017 Received: September 5, 2017 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. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, Mary S. Runner -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # INDICATIONS FOR USE ## 510(k) Number (if known): K170013 Device Name: Eztetic™ BellaTek® Encode® Healing Abutments ### Indications for Use: 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. | Prescription Use | X | |-----------------------------|---| | (Part 21 CFR 801 Subpart D) | | | Over-The-Counter Use | | | (21 CFR 801 Subpart C) | | AND/OR (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) {3}------------------------------------------------ # Eztetic™ BellaTek® Encode® Healing Abutments 510(K) Summary 09/21/2017 #### I. Submitter Information: | | Name: | Biomet 3i | | |------|-----------------------------|------------------------------------------------------|--| | | Address: | 4555 Riverside Drive | | | | | Palm Beach Gardens, Florida 33410 | | | | Phone: | (561) 776-6700 | | | | Contact Person: | Krupal Patel | | | | Job Title: | Senior Regulatory Specialist | | | | Email: | krupal.patel@zimmerbiomet.com | | | | Telephone: | (561) 776-6923 | | | | Fax: | (561) 514-6316 | | | II. | Proprietary Trade Name: | Eztetic™ BellaTek® Encode® Healing Abutments | | | III. | Device Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) | | | IV. | Regulatory Class: | Class II | | | V. | Product Code: | NHA | | ### VI. Predicate Devices: Primary predicate device: - BellaTek® Encode® Healing Abutments referenced in Biomet 3i Dental Abutments and Restorative Components (K072642 / SE 12/20/2007) Reference device: - . Healing Collars referenced in Zimmer 3.1mm Dental Implant System (K142082 / SE 07/28/2014) ### VII. Product Description: The Eztetic™ BellaTek® Encode® Healing Abutment is a healing abutment designed to facilitate gingival tissue healing. It consists of an abutment and a retaining screw that are assembled together. Both components are machined from Titanium Alloy (Ti-6AL-4V ELI). The shelf life of the Eztetic™ BellaTek® Encode® Healing Abutment is 5 years and they are intended for single use only. The device is packaged in a sealed nylon bag and sold sterile. The device is sterilized using gamma irradiation method. {4}------------------------------------------------ #### VIII. Indications for Use: 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. #### IX. Summary of the Technological Characteristics: The Eztetic™ BellaTek® Encode® Healing Abutments is available in 2.9mm restorative platform diameter, four heights: 3, 4, 6 and 8mm and two emergence profiles: 3.8 and 5mm. The height, emergence profile and the screw method of attachment with mating implant are same as primary predicate devices. The major change from the primary predicate device is the restorative platform diameter. However the restorative platform diameter is same as the reference device. The connection geometry of subject device is similar to reference device and they both engage Eztetic™ 3.1mm Dental Implant. The abutment form a passive or clearance fit within the implant internal connection. The retaining screw is used to secure the abutment to the implant. The abutment makes a flaton-flat engagement with top surface of the implant platform. A general device comparison of subject and predicate device is provided in table below. | Feature | Subject Device Eztetic™ BellaTek® Encode® Healing Abutment | Primary Predicate Device BellaTek® Encode® Healing Abutment (K072642) | Reference Device Healing Collars (K142082) | |-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use/ Indications for Use | 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 to the abutment. Restorative Components: ● Temporary Healing | Zimmer 3.1mmD Dental Implants are designed for use in the anterior maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Zimmer 3.1mmD Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to minimally support the | | | Subject Device | Primary Predicate Device | Reference Device | | Feature | Eztetic™ BellaTek® Encode® Healing Abutment | BellaTek® Encode® Healing Abutment (K072642) | Healing Collars (K142082) | | | | 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 components are intended for use as accessories to endosseous dental implants for retention of screw retained abutments to the dental implant. | implant (minimum 1mm circumferential and 2mm apical). The Zimmer 3.1mmD Dental Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region. The 2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex are used for attachment of restorations requiring off-axis correction. The 2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex are designed to be used in edentulous or partially edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement. The 2.9mm Contour Abutment and 2.9mm Contour Abutment Straight Hex are used as a terminal or intermediate abutment for a cemented prosthesis. Abutment can be used for a single- or multiple- unit restoration. The 2.9mm Angled Contour Abutment and 2.9mm Angled Contour Abutment, Straight Hex are | | | | | designed to be used as a | | Feature | Subject Device | Primary Predicate Device | Reference Device | | | EzteticTM BellaTek® Encode® Healing Abutment | BellaTek® Encode® Healing Abutment (K072642) | Healing Collars (K142082) | | | | | terminal or intermediate abutment for a cemented prosthesis where the angle needs to be offset by 17º. Abutment can be used for a single-or multiple-unit restoration. | | | | | The 2.9mm Temporary Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the gingiva during the healing period and prior to final restoration. The 2.9mm Temporary Abutment can be used for cement- retained or screw-retained provisional restorations. The abutments can be used for single-unit and multiple-unit restorations. | | | | | The Ball Abutment is used for retaining overdentures or partial dentures when resilience and facilitated oral hygiene are desired. | | | | | The Healing Collar is used to assist in the forming of the soft tissue during healing before a final restoration is placed. | | | | | The Healing Screw is used to seal the implant internal connection and separate it from the soft tissue which is sutured over the implant | | Feature | Subject Device Eztetic™ BellaTek® Encode® Healing Abutment | Primary Predicate Device BellaTek® Encode® Healing Abutment (K072642) | Reference Device Healing Collars (K142082) | | | | | The Retaining Screws are intended to be used for securing the temporary abutments, final abutments and impression transfers to the implant or implant analog. The long Retaining Screw is intended to be used with Temporary Abutments for fabrication of screw-retained provisional restorations and with Impression Transfers for direct impressions. | | Operating Principle | 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 | The 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 occlusal surface of the device includes machined markings that provide information about the | The Eztetic™ Healing Collar is designed to facilitate gingival tissue healing. The Eztetic™ Healing Collar aids in prosthetic rehabilitation by supporting the surrounding gingival tissue during the healing period. The soft tissue is sutured around the healing collar and the device remains in the mouth until the soft tissue fully develops. The healing collar is threaded onto the implant immediately after implant placement in a one- stage surgical protocol. In a two-stage surgical protocol, the healing collar is threaded on the implant following the bone healing period. | | | Subject Device | Primary Predicate Device | Reference Device | | Feature | Eztetic™ BellaTek® Encode® Healing Abutment | BellaTek® Encode® Healing Abutment (K072642) | Healing Collars (K142082) | | | device remains in the mouth until the soft tissue fully develops. The occlusal surface of the device includes machined markings that provide information about the mating implant's position and orientation. | mating implant's position and orientation. | | | Technological Characteristics | Encode® Coding Scheme (Machined Markings) | Encode® Coding Scheme (Machined Markings) | No Machined Markings | | Method of Attachment (Mating) | Attached to the implant by a retaining screw | Attached to the implant by a retaining screw | Threads into implant | | Emergence Profile | 3.8mm and 5.0mm | 3.8mm - 7.5mm | 3.7mm and 4.5mm | | Height | 3, 4, 6 and 8mm | 3, 4, 6 and 8mm | 1.5, 3.0 and 4.5mm | | Restorative Platform Diameter | 2.9mm | 3.4, 4.1, 5.0 and 6.0mm | 2.9mm | | Connection Geometry | Flat-to-flat mating with a passive fit within the implant internal connection to engage Eztetic™ 3.1mm Dental Implant | Flat-to-flat mating with a passive fit within the implant internal connection to engage Biomet 3i External and Internal Hexagon Implants | Flat-to-flat mating with a passive fit within the implant internal connection to engage Eztetic™ 3.1mm Dental Implant | | Mating Implant | Zimmer Dental 3.1mm Eztetic™ Implant System | Biomet 3i Internal and External Hexagon Implant System | Zimmer Dental 3.1mm Eztetic™ Implant System | | Packaging | Nylon Bag | Nylon Bag | Sealed Tray in an outer chipboard box | | Materials | Titanium Alloy (Ti-6Al-4V ELI) | Titanium Alloy (Ti-6Al-4V ELI) | Titanium Alloy (Ti-6Al-4V ELI) | | Feature | Subject Device EzteticTM BellaTek® Encode® Healing Abutment | Primary Predicate Device BellaTek® Encode® Healing Abutment (K072642) | Reference Device Healing Collars (K142082)…