BIODENTA CUSTOMIZED ABUTMENT
Device Facts
| Record ID | K110778 |
|---|---|
| Device Name | BIODENTA CUSTOMIZED ABUTMENT |
| Applicant | Biodenta Swiss AG |
| Product Code | NHA · Dental |
| Decision Date | Jul 29, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3630 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The Biodenta Customized Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. The Biodenta Customized Abutment is compatible with the following implant systems: -Internal hex systems with flat-to-flat dimensions of 1.78mm or greater: Friadent: FRIALIT Implant. XiVA Implant. 3i:Certain Internal Connect Type: Astra: Osseospeed Implant. Osseospeed TX implant; Biohorizons: Internal Implant System, Tapered Internal Implant System, Single-Stage Implant System; Lifecore: Lifecore RENOVA Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System. -Nobel Biocare Replace: NobelReplace Straight, NobelReplace Tapered; Replace Select Tapered, Replace Select Straight; for the NP, RP, WP and 6.0 implants. -External hex systems with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare Branemark, 3i, BioHorizons, and Lifecore.
Device Story
Biodenta Customized Abutment consists of titanium abutments and screws used to support cement-retained dental restorations; compatible with various internal and external hex implant systems. Abutments are milled using computer-assisted technology to achieve specific patient-tailored geometry. Device is used by dental professionals in clinical settings to connect dental implants to prosthetic teeth. Output is a customized mechanical interface that secures the prosthesis to the implant, facilitating functional and aesthetic tooth replacement. Benefits include patient-specific fit and compatibility with multiple established implant platforms.
Clinical Evidence
Bench testing only. Fatigue testing conducted per ISO 14801 on worst-case connection platforms demonstrated sufficient mechanical strength for intended clinical applications.
Technological Characteristics
Material: Titanium grade Ti-6AL-4V ELI (ASTM F-136). Manufacturing: Computer-assisted milling. Compatibility: Internal hex (>=1.78mm) and external hex (>=2.4mm) implant systems. Mechanical interface: Abutment screw fixation.
Indications for Use
Indicated for partially or fully edentulous patients requiring single or multiple tooth prostheses supported by dental implants in the maxilla or mandible.
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
- TDS Abutment for Nobel Biocare Replace (K091026)
- TDS Titanium Abutment for Nobel Branemark (K091392)
- XiVE TG Abutments (K032302)
- PrimaConnex CAD/CAM Abutment System (K072241)
- AtlantisTM Abutments in Zirconia for 3i Certain Interface (K063734)
Related Devices
- K193529 — ATLANTIS Abutment for MIS Conical Connection Implants · Dentsply Sirona · Mar 5, 2020
- K143051 — ArgenIS Titanium Abutments · The Argen Corporation · Sep 16, 2015
- K143505 — Zimmer Patient-Specific Abutment, Internal Hex, Titanium · Zimmer Dental, Inc. · Jun 25, 2015
- K161713 — Dentium CAD/CAM Abutments · Dentium Co., Ltd. · Dec 16, 2016
- K210362 — s-Clean Pre-Milled Abutment · Dentis Co., Ltd. · Aug 19, 2021
Submission Summary (Full Text)
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K///0778
## 510K Summary
JUL 2 9 2011
Owner's name: Biodenta Swiss AG
| Address: | Tramstrasse 16 |
|-------------|------------------|
| | 9442 Berneck. |
| | Switzerland |
| Phone: | +41 71 747 11 11 |
| Fax Number: | +41 71 747 11 12 |
Contact Person: Mr. David Eiler, Regulatory Manager Date Summary prepared: July 29, 2011
Trade name: Biodenta Customized Abutment Common Name: Endosseous dental implant abutment Device classification name: abutment, implant, dental, endosseous
Product Code: NHA Regulation number: 21 CFR 872.3630
Legally marketed device to which equivalence is claimed (predicate device):
| Company: | Pou Yu Biotechnology Co., Ltd. |
|----------------|-----------------------------------------------------------|
| Device Name: | TDS Abutment for Nobel Biocare Replace |
| 510(k) number: | K091026 |
| Company: | Pou Yu Biotechnology Co., Ltd. |
| Device Name: | TDS Titanium Abutment for Nobel Branemark |
| 510(k) number: | K091392 |
| Company: | Friadent GmbH |
| Device Name: | XiVE TG Abutments |
| 510(k) number: | K032302 |
| Company: | Lifecore Biomedical Inc. |
| Device Name: | PrimaConnex CAD/CAM Abutment System |
| 510(k) number: | K072241 |
| Company: | Atlantis Components, Inc. |
| Device Name: | AtlantisTM Abutments in Zirconia for 3i Certain Interface |
| 510(k) number: | K063734 |
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### Indications for Use:
The Biodenta Customized Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
The Biodenta Customized Abutment is compatible with the following implant systems:
-Internal hex systems with flat-to-flat dimensions of 1.78mm or greater: Friadent: FRIALIT Implant. XiVA Implant. 3i:Certain Internal Connect Type: Astra: Osseospeed Implant. Osseospeed TX implant; Biohorizons: Internal Implant System, Tapered Internal Implant System, Single-Stage Implant System; Lifecore: Lifecore RENOVA Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System.
-Nobel Biocare Replace: NobelReplace Straight, NobelReplace Tapered; Replace Select Tapered, Replace Select Straight; for the NP, RP, WP and 6.0 implants. -External hex systems with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare Branemark, 3i, BioHorizons, and Lifecore.
### Device Description:
Biodenta Customized Abutments are titanium abutments designed to be used in coniunction with specific dental implants utilizing the Biodenta customized abutment screws to secure the abutment to the implant. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch.
The abutment is milled using computer-assisted technology that enables the creation of final abutments that are manufactured with specific geometry. The abutment is made from titanium grade Ti-6AL-4V ELI (meets ASTM standard F-136). The abutment screw and interface is made from titanium grade Ti-6AL-4V ELI (meets ASTM standard F-136).
The Biodenta Customized Abutment is compatible with the following implant systems:
-Internal hex systems with flat-to-flat dimensions of 1.78mm or greater: Friadent: FRIALIT Implant, XiVA Implant, 3i:Certain Internal Connect Type; Astra: Osseospeed Implant. Osseospeed TX implant: Biohorizons: Internal Implant System. Tapered Internal Implant System, Single-Stage Implant System; Lifecore: Lifecore RENOVA
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Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System.
-Nobel Biocare Replace: NobelReplace Straight, NobelReplace Tapered; Replace Select Tapered. Replace Select Straight; for the NP, RP, WP and 6.0 implants. -External hex systems with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare Branemark, 3i, BioHorizons, and Lifecore.
### Non-clinical Testing Data:
Fatigue testing was conducted according to ISO 14801 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for each Biodenta Customized Abutment connection platform. These results show that Biodenta Customized Abutment have sufficient mechanical strength for their intended clinical application and are compatible with the implant systems for which they are intended.
#### Equivalence to marketed device:
Biodenta Swiss AG demonstrated that, for the purposes of FDA's regulation of medical devices, the Biodenta Customized Abutment is substantially equivalent to the predicate devices in intended use, material composition (except to K072241 and K063734 which are zirconia), fundamental scientific technology, princibles of operation, and basic design. When compared with the predicate devices, no new questions of safety or effectiveness have been raised for Biodenta Customized Abutment.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biodenta Swiss AG C/O Ms. Angela Blackwell Senior Consultant Biologics Consulting Group Tramstrasse 16 Berneck Switzerland 9442
JUL 2 9 2011
Re: K110778
Trade/Device Name: Biodenta Customized Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 19, 2011 Received: July 20, 2011
Dear Ms. Blackwell:
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.
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Page 2 - Ms. Blackwell
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 device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours.
Sixon Kunnen
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/1 description: The image shows the logo for Biodenta. The logo consists of the word "biodenta" in a sans-serif font, with a registered trademark symbol to the right of the word. Above the word is a graphic of three curved lines, stacked on top of each other.
# Indications for Use
K110778
510(k) Number (if known): __
Device Name: Biodenta Customized Abutment
Indications for Use:
The Biodenta Customized Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
The Biodenta Customized Abutment is compatible with the following implant systems: - Internal hex systems with flat-to-flat dimensions of 1.78mm or greater: Firadent: FRIALIT Implant, XiVA Implant; 3i: Certain Internal Connect Type; Astra: Osseospeed Implant, Osseospeed TX Implant; BioHorizons: Internal Implant System, Tapered Internal Implant System, Single-Stage Implant System; Lifecore: Lifecore RENOVA™ Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System.
- Nobel Biocare Replace: NobelReplace Straight, NobelReplace Tapered; Replace Select Tapered, Replace Select Straight; for the NP, RP, WP and 6.0 implants.
- External hex systems with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare Branemark, 3i, BioHorizons, and Lifecore.
Prescription Use × (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)
urrence of CDRH, Office of Device Evaluation (ODE)
Susan Kumpan
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K110778
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