(47 days)
No
The summary describes a physical dental device with machined markings for identification during impressions or scans. There is no mention of software, algorithms, or any technology that processes data using AI or ML.
Yes.
The device is intended to aid in soft tissue contouring during the healing period after implant placement, which is a therapeutic function.
No
Explanation: The device is described as an accessory to dental implants used for healing and tissue preparation, and it specifically mentions aiding in soft tissue contouring and creating an emergence profile for the final prosthesis. There is no mention of it being used to diagnose a medical condition or disease.
No
The device description clearly states it is a physical healing abutment with machined markings, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is an "accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tissue for acceptance of a final abutment and restoration." This describes a device used in vivo (within the body) to aid in the healing process and prepare tissue for a subsequent restoration.
- Device Description: The description focuses on the physical design of the abutments, their function in soft tissue contouring, and features for identification during impressions or scans. There is no mention of analyzing samples from the body (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information about a disease or condition.
- Using reagents or assays.
- Measuring analytes.
The device is a medical device used in a surgical and healing context, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes
NHA
Device Description
The TSV™ BellaTek® Encode® 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. The occlusal surface of the device include markings that provide information about the mating implant's position and orientation.
The principal of operation and Encode "Coding Scheme of the same as the primary predicate device. The pattern of the markings for the subject device is specific to the Tapered Screw-Vent", and Trabecular Metal implant lines.
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 11137-1 and 11137-2, demonstrating assurance level (SAL) of 10-6, Limulus amebocyte lysate (LAL) testing according to AANSI/AAMI ST 72, biological evaluation according to ISO 10993-1 by reference to K170013, demonstrating acceptable biocompatibility, accelerated and real time aging studies by reference to K170013, demonstrating a shelf life of five years, and MR evaluation by reference to K170013. The subject devices are labeled as MR conditional.
No clinical data were included in this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K061410, K133339, K113753, K132258
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 logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 13, 2017
Biomet 3i % Linda Schulz Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K173374
Trade/Device Name: TSV™ BellaTek® Encode® Healing Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: October 26, 2017 Received: October 27, 2017
Dear Linda Schulz:
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.
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K173374
Device Name
TSVTM BellaTek® Encode® Healing Abutments
Indications for Use (Describe)
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.
| 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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3
510(k) Summary K173374 Biomet 3i TSV™ BellaTek® Encode® Healing Abutments
October 26, 2017
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Biomet 3i
4555 Riverside Drive
Palm Beach Gardens, FL 33410
Telephone: +1 (561) 776-6700
Fax: +1 (561) 776-1272 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Nichole O'Neil, Regulatory Affairs Specialist |
| Representative/Consultant | Linda K. Schulz, BSDH, RDH
Floyd G. Larson, MS, MBA
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego, CA 92130
Telephone: +1 (858) 792-1235
Fax: +1 (858) 792-1236
Email: lschulz@paxmed.com
flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | TSVTM BellaTek® Encode® Healing Abutments |
|---|---|
| Common Name | Dental Implant Abutment |
| Classification Name | Endosseous dental implant abutment |
| Classification Regulations | 21 CFR 872.3630, Class II |
| Product Code | NHA |
| Classification Panel: | Dental Products Panel |
| Reviewing Branch: | Dental Devices Branch |
PREDICATE DEVICE INFORMATION
| Primary Predicate: | ||
|---|---|---|
| K170013 | Eztetic™ BellaTek® Encode® Healing Abutments | Biomet 3i |
| Reference Predicates for Compatibility: | ||
| K061410 | Zimmer Dental Implant System | Zimmer Dental, Inc. |
| K133339 | Zimmer Dental Tapered Screw-Vent® T Implant, HA Coated | Zimmer Dental, Inc. |
| Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated | ||
| K113753 | Tapered Screw-Vent® X Implant | Zimmer Dental, Inc. |
| K132258 | Zimmer Dental Trabecular Metal Implant System | Zimmer Dental, Inc. |
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510(k) Summary Page 2 of 4
INDICATIONS FOR USE
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.
DEVICE DESCRIPTION
The purpose of this submission is to obtain 510(k) premarket clearance for the TSVIM BellaTek® Encode® Healing Abutments compatible with Tapered Screw-Vent® and Trabecular Metal implant systems. Abutments sizing is based on implant platform diameter.
TSV™ BellaTek® Encode® 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. The occlusal surface of the device include markings that provide information about the mating implant's position and orientation.
The principal of operation and Encode "Coding Scheme of the same as the primary predicate device. The pattern of the markings for the subject device is specific to the Tapered Screw-Vent", and Trabecular Metal implant lines.
| Compatible Implant Sizes | |||
|---|---|---|---|
| Implant System | Implant Diameter | ||
| (mmD) | Implant Platform | ||
| (mmD) | Implant Length | ||
| (mmL) | |||
| Tapered Screw -Vent® | 3.7 | 3.5 | 8, 10, 11.5, 13,16 |
| Tapered Screw -Vent® | 4.1 | 3.5 | 8, 10, 11.5, 13,16 |
| Tapered Screw -Vent® | 4.7 | 4.5 | 8, 10, 11.5, 13,16 |
| Tapered Screw -Vent® | 6.0 | 5.7 | 8, 10, 11.5, 13,16 |
| Screw-Vent® | 3.3 | 3.5 | 8,10,13,16 |
| Screw-Vent® | 3.7 | 3.5 | 8,10,13,16 |
| Screw-Vent® | 4.7 | 4.5 | 8,10,13,16 |
| Trabecular Metal™ | 3.7 | 3.5 | 10, 11.5, 13 |
| Trabecular Metal™ | 4.1 | 3.5 | 10, 11.5, 13 |
| Trabecular Metal™ | 4.7 | 4.5 | 10, 11.5, 13 |
| Trabecular Metal™ | 6.0 | 5.7 | 10, 11.5, 13 |
Compatible Implant Sizes
PERFORMANCE DATA
Non-clinical testing data submitted or relied upon to demonstrate substantial equivalence included radiation sterilization validation according to ISO 11137-1 and 11137-2, demonstrating assurance level (SAL) of 10 °, Limulus amebocyte lysate (LAL) testing according to AANSI/AAMI ST 72, biological evaluation according to ISO 10993-1 by reference to K170013, demonstrating acceptable biocompatibility, accelerated and real time aging studies by reference to K170013, demonstrating a shelf life of five years, and MR evaluation by reference to K170013. The subject devices are labeled as MR conditional.
No clinical data were included in this submission.
5
EQUIVALENCE TO MARKETED DEVICE
Biomet 3i submits the information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the subject device, TSV™ BellaTek® Encode® Healing Abutments, is substantially equivalent in indications and design principles to the legally marketed primary predicate device.
| Comparison | Subject Device | Primary Predicate Device |
|---|---|---|
| TSVTM BellaTek® Encode® Healing | ||
| Abutments | K170013 | |
| The EzteticTM BellaTek® Encode® | ||
| Healing Abutments | ||
| Biomet 3i | Biomet 3i | |
| Indications for Use | The TSVTM 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 EzteticTM 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. | ||
| Design | ||
| Scanning Identification | Encode® Coding Scheme | |
| (Machined Markings) | Encode® Coding Scheme | |
| (Machined Markings) | ||
| Emergence Profile (mm) | 3.8, 5.0, 5.6, 6.0, 6.8 | 3.8, 5.0 |
| Platform Diameter (mm) | 3.5, 4.5, 5.7 | 2.9 |
| Gingival Height (mm) | 3, 5, 7 | 3, 4, 6, 8 |
| Implant/Abutment | ||
| Connection | Internal | Internal |
| Material | ||
| Abutment | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Screw | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
The intended use of the subject device as a healing abutment machined markings for identification is the same as the primary predicate K170013. The Indications for the subject device is the same as the primary predicate Eztetic™ BellaTek® Encode® Healing Abutment, K170013, changing only the name.
The principal of operation and basic design of the Encode Coding Scheme of the subject device is the same as the primary predicate device, Eztetic™ BellaTek® Encode® Healing Abutment, K170013. The pattern of the markings for the subject device is specific to the Tapered Screw-Vent, and Trabecular Metal implant lines.
All of the subject device components are manufactured from the same facilities, using the same manufacturing processes as used for the previously cleared primary predicate device in K170013.
6
CONCLUSION
The subject device and the primary predicate device have intended use, have same technological characteristics, and are made of the same materials. The subject device and predicate devices encompass the same design principals, including the Encode® Coding Scheme. The subject and predicate devices are packaged in the same materials and are to be sterilized using the same methods.
The data included in this submission demonstrate substantial equivalence to the primary predicate device listed above.