Biodenta Customized Abutment - Titanium

K151295 · Biodenta Swiss AG · NHA · Dec 1, 2015 · Dental

Device Facts

• Record ID: K151295
• Device Name: Biodenta Customized Abutment - Titanium
• Applicant: Biodenta Swiss AG
• Product Code: NHA · Dental
• Decision Date: Dec 1, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The Biodenta Customized Abutment - Titanium 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.

Device Story

One-piece custom titanium abutment; used with dental implants to support single/multiple tooth prostheses. Dental technician uses CAD software to design upper portion; Biodenta milling centers manufacture device. Final cement-retained restoration constructed in lab per dentist specifications. Abutment secured to implant via abutment screw. Used in dental clinics; operated by dental professionals. Provides structural support for prosthetic teeth; enables customized fit for various implant systems.

Clinical Evidence

Bench testing only. Fatigue testing conducted per FDA Class II Special Controls Guidance Document for Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. Worst-case scenario testing confirmed sufficient mechanical fatigue strength. Biocompatibility assessment determined testing unnecessary due to established history of Ti-6Al-4V ELI in dental applications.

Technological Characteristics

Material: Ti-6Al-4V ELI (ISO 3852-3, ASTM F136). One-piece custom abutment with abutment screw. CAD/CAM manufacturing process. Non-sterile, single-use. Compatible with various implant systems (Biodenta, Nobel Biocare, Biomet 3i, Dentsply, Straumann, Zimmer, Biohorizons, Osstem). Sterilization per ISO 17665-1:2006.

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

• Biodenta Customized Abutment (K110778)
• Inclusive Titanium Abutments For Astra Tech Osseospeed Implants (K100993)
• Inclusive Titanium Abutments (K142118)
• Inclusive Titanium Abutments (K142115)
• Biodenta Dental Implant System - Multi-Use Abutment (K123491)

Reference Devices

• TDS Abutment for Friadent Xive (K103339)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 1, 2015

Biodenta Swiss AG Mr. David Eiler Regulatory Manager Tramstrasse 16 Berneck, St. Gallen 9442 SWITZERLAND

Re: K151295

Trade/Device Name: Biodenta Customized Abutment - Titanium Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 5, 2015 Received: November 23, 2015

Dear Mr. Eiler:

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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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 (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.

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang
-S

for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/1 description: The image shows the logo for Biodenta. The logo consists of the word "biodenta" in gray lowercase letters, with a registered trademark symbol to the right of the word. Above the word is a curved shape in two shades of green and gray.

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) K151295

Device Name

Biodenta Customized Abutment - Titanium

#### Indications for Use (Describe)

The Biodenta Customized Abutment - Titanium 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 - Titanium is compatible with the following dental implant systems:

| Implant Brand, Type | Implant Platform Name: Implant Diameter |
|---------------------------------------------------|--------------------------------------------------------------------|
| Biodenta, Bone Level and Tapered | B1: 3.5 mm; B2: 4.1, 4.8, 6.0 mm |
| Nobel Biocare, Nobel Replace straight and tapered | NP: 3.5 mm; RP: 4.3 mm; WP: 5.0 mm; 6.0: 6.0 mm |
| Nobel Biocare, NobelActive | NP: 3.5 mm; RP: 4.3, 5.0 mm |
| Biomet 3i, Certain Internal | 3.4: 3.25, 4.0 mm; 4.1: 4.0, 5.0 mm; 5.0: 5.0, 6.0 mm; 6.0: 6.0 mm |
| Dentsply, Astra Tech OsseoSpeed | 3.5/4.0: 3.5, 4.0 mm; 4.5/5.0: 4.5, 5.0 mm |
| Straumann, Bone Level | NC: 3.3 mm; RC: 4.1, 4.8 mm |
| Zimmer, Screw Vent and Screw Vent Tapered | 3.5: 3.3, 3.7, 4.1 mm; 4.5: 4.7 mm; 5.7: 6.0 mm |
| Biohorizons, Internal straight and tapered | 3.5: 3.5, 3.8 mm; 4.5: 4.0, 4.6 mm; 5.7: 5.0, 6.0, 5.8 mm; |
| Osstem (Hiossen), GS and TS | Mini: 3.5 mm; Regular: 4.0, 4.5, 5.0 mm |

| 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/1 description: The image shows the logo for Biodenta. The logo features the word "biodenta" in lowercase letters, with a stylized graphic above the text. The graphic is a curved shape in two shades of green and gray, positioned above the "bio" portion of the word. A small "R" in a circle is located to the right of the word.

## K151295

# 5 510(k) Summary

| Owner's name: | Biodenta Swiss AG |
|-----------------------------|-----------------------------------------------|
| Address: | Tramstrasse 16<br>9442 Berneck<br>Switzerland |
| Phone: | [phone] |
| Fax number: | + 41 71 747 11 12 |
| Contact person: | Mr. David Eiler, Regulatory Manager |
| Date summary prepared: | November 27, 2015 |
| Trade / proprietary name: | Biodenta Customized Abutment - Titanium |
| Common name: | Endosseous dental implant abutment |
| Device classification name: | Endosseous Dental Implant Abutment |
| Product code: | NHA |
| Regulation number : | 21 CFR 872.3630 |

Legally marketed device to which equivalence is claimed (predicate device):

| 1. Company: | Biodenta Swiss Ag |
|----------------|--------------------------------------------------------------------|
| Device name: | Biodenta Customized Abutment |
| 510(k) number: | K110778 (primary predicate) |
| 2. Company: | Prismark Dentalcraft, Inc |
| Device name: | Inclusive Titanium Abutments For Astra Tech Osseospeed<br>Implants |
| 510(k) number: | K100993 |

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Image /page/4/Picture/1 description: The image shows the logo for Biodenta. The logo features the word "biodenta" in gray lowercase letters. Above the word is a curved design in light gray and light green. To the right of the word is a circled R symbol.

| 3. Company: | Prismark Dentalcraft, Inc |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Device name: | Inclusive® Titanium Abutments compatible with:<br>Straumann Bone Level, Nobel Biocare Branemark, and<br>Nobel Biocare NobelActive Implants |
| 510(k) number: | K142118 |
| 4. Company: | Prismark Dentalcraft, Inc |
| Device name: | Inclusive® Titanium Abutments, compatible with Zimmer<br>Screw- Vent, Biomet 3i Certain, and Nobel Biocare<br>NobelReplace Implants |
| 510(k) number: | K142115 |
| 5. Company: | Biodenta Swiss Ag |
| Device name: | Biodenta Dental Implant System - Multi-Use Abutment |
| 510(k) number: | K123491 |

## Indications for Use:

The Biodenta Customized Abutment - Titanium 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 - Titanium is compatible with the following dental implant systems:

110778

| Implant Brand, Type | Implant Platform Name: Implant Diameter |
|---------------------------------------------------|-----------------------------------------------------------------------|
| Biodenta, Bone Level and Tapered | B1: 3.5 mm; B2: 4.1, 4.8, 6.0 mm |
| Nobel Biocare, Nobel Replace straight and tapered | NP: 3.5 mm; RP: 4.3 mm;<br>WP: 5.0 mm; 6.0: 6.0 mm |
| Nobel Biocare, NobelActive | NP: 3.5 mm; RP: 4.3, 5.0 mm |
| Biomet 3i, Certain Internal | 3.4: 3.25, 4.0 mm; 4.1: 4.0, 5.0 mm;<br>5.0: 5.0, 6.0 mm; 6.0: 6.0 mm |
| Dentsply, Astra Tech OsseoSpeed | 3.5/4.0: 3.5, 4.0 mm; 4.5/5.0: 4.5, 5.0 mm |
| Straumann, Bone Level | NC: 3.3 mm; RC: 4.1, 4.8 mm |
| Zimmer, Screw Vent and Screw Vent Tapered | 3.5: 3.3, 3.7, 4.1 mm; 4.5: 4.7 mm; 5.7: 6.0 mm |
| Biohorizons, Internal straight and tapered | 3.5: 3.5, 3.8 mm; 4.5: 4.0, 4.6 mm;<br>5.7: 5.0, 6.0, 5.8 mm; |
| Osstem (Hiossen), GS and TS | Mini: 3.5 mm; Regular: 4.0, 4.5, 5.0 mm |

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Image /page/5/Picture/1 description: The image shows the logo for Biodenta. The logo features the word "biodenta" in gray lowercase letters. Above the word is a curved design in light gray and light green. To the right of the word is a circled R symbol.

## Device Description:

Biodenta Customized Abutment - Titanium is a one-piece custom abutment made of titanium. It utilizes an Abutment Screw for abutment retention.

The upper portion is designed by a dental technician using CAD software and manufactured at Biodenta milling centers. The final cement retained restoration is constructed in the lab according to the dentist's specifications.

The Abutment and the Abutment Screw are made of biocompatible Ti-6AI-4V ELI conforming to ISO 3852-3 and ASTM F136.

## Non-clinical Testing Data:

Fatigue testing was conducted according to FDA Guidance: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff. The worst-case scenario for the Biodenta Customized Abutment - Titanium and implant was tested. The results show that the Biodenta Customized Abutment - Titanium has sufficient mechanical strength for the intended clinical application. A biocompatibility assessment determined that biocompatibility testing was not necessary. Titanium has a long history of use in dental applications and Biodenta also has an established history of manufacturing titanium based dental devices.

The engineering of the Biodenta Customized Abutment - Titanium was carried out by measuring the original implant manufacturer's implant analogs, abutments, and abutment screws. Compatible abutments and screws were developed based on the measurement results. An enqineering and compatibility analysis was carried out to ensure that the Biodenta Customized Abutment - Titanium fits well with the original manufacturer's implants (Nobel Biocare, Nobel Replace; Nobel Biocare, NobelActive; Biomet 3i, Certain Internal; Dentsply, Astra Tech OsseoSpeed; Straumann, Bone Level; Zimmer, Screw Vent and Screw Vent Tapered; Biohorizons, Internal straight and tapered; Osstem (Hiossen), GS/TS). Additionally fatigue testing according to FDA Guidance for Industry and Staff -Class II Special Controls Guidance Document: Root- form Endosseous Dental Implants and Endosseous Dental Implant Abutments was carried out to confirm the mechanical fatigue strength of the Biodenta Customized Abutment - Titanium on the original manufacturer's implant fixture.

The Sterilization Validation was carried out according to ISO 17665-1:2006. The recommended sterilization method is provided in the Information for Use.

## Equivalence to marketed device:

While the indications for use statements between the subject and predicate device are not identical, the intended use is still the same. They are all abutments intended to be compatible with a specific subset of implants to support dental restorations. Biodenta Swiss AG demonstrated that, for the purposes of FDA's regulation of medical devices, the Biodenta Customized Abutment - Titanium is substantially equivalent to the predicate devices in intended use, material composition, fundamental scientific technology, principles of operation, and basic design.

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Image /page/6/Picture/1 description: The image shows the logo for "biodenta". The word "biodenta" is written in gray, with a registered trademark symbol to the right of the "a". Above the word is a curved design in gray and light green.

#### Summary Substantial Equivalence Comparison to predicate devices:

| | Subject Device | Primary Predicate | Reference Predicates | | | | |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | Biodenta Swiss AG | Biodenta Swiss AG | Prismark<br>Dentalcraft, Inc | Prismark<br>Dentalcraft, Inc | Prismark<br>Dentalcraft, Inc | Biodenta Swiss<br>AG | Pou Yu Biotechnology<br>Co., Ltd. |
| Device<br>Name | Biodenta<br>Customised<br>Abutment -<br>Titanium | Biodenta Customized<br>Abutment | Inclusive Titanium<br>Abutments For Astra<br>Tech Osseospeed<br>Implants | Inclusive® Titanium<br>Abutments compatible<br>with: Straumann Bone<br>Level, Nobel Biocare<br>Branemark , and Nobel<br>Biocare NobelActive<br>Implants | Inclusive® Titanium<br>Abutments, compatible<br>with Zimmer Screw-<br>Vent, Biomet 3i Certain,<br>and Nobel Biocare<br>NobelReplace Implants | Biodenta<br>Dental Implant<br>System - Multi-<br>Use Abutment | TDS Abutment for<br>Friadent Xive |
| 510(k)<br>Number | New device | K110778 | K100993 | K142118 | K142115 | K123491 | K103339 |
| Intended<br>use | The Biodenta<br>Customized<br>Abutment is<br>intended for use<br>with dental<br>implants as a<br>support for single<br>or multiple tooth<br>prostheses in the<br>maxilla or mandible<br>of a partially or fully<br>edentulous patient. | The Biodenta Customized<br>Abutment is intended for<br>use with dental implants as<br>a support for single or multi<br>ple tooth prostheses in the<br>maxilla or mandible of a par<br>tially or fully edentulous pat<br>ient. The Biodenta Custom<br>ized Abutment is compatible<br>with the following implant<br>systems: - Internal hex sys<br>tems with flat-to-flat dimen<br>sions of 1.78mm or greater:<br>Firadent: FRIALIT Implant,<br>XiVA Implant: 3i: Certain Inte<br>rnal Connect Type; Astra:<br>Osseospeed Implant, Osseo<br>speed TX Implant; BioHoriz<br>ons: Internal Implant Syst<br>em, Tapered Internal Impl<br>ant System, Single-Stage<br>Implant System; Life core:<br>Lifecore RENOVA Internal<br>Hex Implant System; Zimm<br>er: Tapered Screw-Vent Imp<br>lant System, Screw-Vent Im<br>plant System, AdVent Impla<br>nt System. - Nobel Biocare<br>Replace: NobelReplace Stra<br>ight, NobelReplace Tapered<br>Replace Select Tapered, Re<br>place Select Straight; for the<br>NP,RP,WPand6.0 implants.<br>- External hex systems with<br>flat-to-flat dimensions of 2.4<br>mm or greater:Nobel Bioca | The InclusiveO<br>Titanium Abutments<br>for Astra<br>OsseoSpeed’M<br>Implants are<br>premanufactured<br>prosthetic<br>components directly<br>connected to<br>endlosseous dental<br>implants and are<br>intended<br>for use as an aid in<br>prosthetic<br>rehabilitation. They<br>are compatible with<br>the Astra Tech<br>OsseoSpeed" 3.0,<br>3.5, 4.0, 4.5, 5.0<br>implants. | Inclusive® Titanium<br>Abutments are<br>premanufactured<br>prosthetic<br>components directly<br>connected to<br>endosseous dental<br>implants and are<br>intended for use as<br>an aid in prosthetic<br>rehabilitation.<br>Inclusive® Titanium<br>Abutments are<br>compatible with:<br>- Straumann: Bone<br>Level NC and RC<br>implant sizes<br>- Nobel Biocare:<br>Branemark RP size<br>implant<br>- Nobel Biocare<br>NobelActive NP and<br>RP internal<br>connection implants | Inclusive® Titanium<br>Abutments are<br>premanufactured<br>prosthetic components<br>directly connected to<br>endosseous dental<br>implants and are<br>intended for use as an<br>aid in prosthetic<br>rehabilitation.<br>Inclusive® Titanium<br>Abutments are<br>compatible with:<br>- Biomet: 3i Certain<br>internal hex implants in<br>3.4, 4.1, 5.0, 6.0 mm<br>sizes<br>- Nobel Biocare:<br>NobelReplace straight<br>and tapered internal<br>connection<br>implants in NP, RP, WP,<br>6.0 mm sizes<br>- Zimmer: Screw-Vent<br>and Tapered Screw-<br>Vent internal hex<br>implants in 3.5,<br>4.5, 5.7 mm sizes | Biodenta<br>Dental Implant<br>System Multi<br>Use Abutments<br>are intended for<br>terminal or<br>intermediate<br>abutment<br>support for<br>fixed or<br>removable<br>crown,<br>bridgework and<br>to retain<br>overdentures. | TDS Abutment for Friadent<br>Xive is intended for use<br>with dental implants as a<br>support for single or<br>multiple tooth prostheses<br>in the maxilla or mandible<br>of a partially or fully<br>edentulous patient.<br>This device is compatible<br>with the following implant<br>systems which have an<br>internal hex with flat-to-flat<br>dimensions of 1.78mm or<br>greater: Firadent: FRIALIT<br>Implant, XiVA Implant; 3i:<br>Internal Connect Type;<br>Astra: Osseoispeed<br>Implant, Osseospeed TX<br>Implant; BioHorizons:<br>Internal Implant System,<br>Tapered Internal Implant<br>System, Single-Stage<br>Implant System, Laser-<br>lok®&3.0 implant system;<br>Lifecore: , Lifecore:<br>RENOVATM Internal Hex<br>Implant System; Zimmer:<br>Tapered Screw-Vent<br>Implant System, Screw-<br>Vent Implant System,<br>AdVent Implant System;<br>Osstem: GS System;<br>Nobel Biocare: Active<br>Implant. |
| | Subject Device | Primary Predicate | Reference Predicates | | | | |
| Company | Biodenta Swiss AG | Biodenta Swiss AG | Prismark<br>Dentalcraft, Inc | Prismark<br>Dentalcraft, Inc | Biodenta Swiss<br>AG | Pou Yu Biotechnology<br>Co., Ltd. | |
| Device<br>Name | Biodenta<br>Customised<br>Abutment -<br>Titanium | Biodenta Customized<br>Abutment | Inclusive Titanium<br>Abutments For Astra<br>Tech Osseospeed<br>Implants | Inclusive® Titanium<br>Abutments, compatible<br>with: Straumann Bone<br>Level, Nobel Biocare<br>Branemark , and Nobel<br>Biocare NobelActive<br>Implants | Biodenta<br>Dental Implant<br>System - Multi-<br>Use Abutment | TDS Abutment for<br>Friadent Xive | |
| 510(k)<br>Number | New device | K110778 | K100993 | K142118 | K123491 | K103339 | |
| Compatibl<br>e implant<br>types | - Dentsply, AstraTech<br>OsseoSpeed<br>- Biomet 3i, Certain<br>Internal<br>- Zimmer, Screw Vent<br>- Nobel Biocare,<br>NobelReplace<br>- Nobel Biocare,<br>NobelActive<br>- Straumann, Bone<br>Level<br>- BioHorizons, Internal<br>- Osstem, GS/TS<br>- Biodenta, Bone Level<br>and Tapered | - Dentsply, AstraTech<br>OsseoSpeed<br>- Biomet 3i, Certain<br>Internal<br>- Zimmer, Screw Vent<br>- Nobel Biocare,<br>NobelReplace<br>- Nobel Biocare,<br>NobelActive<br>- Straumann, Bone<br>Level | - Dentsply, AstraTech<br>OsseoSpeed | - Nobel Biocare,<br>NobelActive<br>- Straumann, Bone<br>Level<br><br>- Biomet: 3i Certain<br>internal<br>- Zimmer: Screw-Vent<br>- Nobel Biocare:<br>NobelReplace | - Biodenta, Bone<br>Level and Tapered | - Dentsply, AstraTech<br>OsseoSpeed<br>- Biomet 3i, Certain<br>Internal<br>- Zimmer, Screw Vent<br>- Nobel Biocare,<br>NobelReplace<br>- Nobel Biocare,<br>NobelActive<br>- Straumann, Bone<br>Level<br>- BioHorizons, Internal<br>- Osstem, GS/TS | |

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Image /page/7/Picture/1 description: The image shows the logo for Biodenta. The logo consists of the word "biodenta" in gray, with a registered trademark symbol to the right of the word. Above the word is a curved design in gray and green.

#### Custom Design

| maximal<br>Abutment<br>Angulation | 30° | 30° | 30° | 30° | 30° | 30° | 30° |
|-----------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------|-------------------|------------------------------------------------------------|
| Abutment<br>Diameter | 4.5 - 15 mm | 5 - 10 mm | max. 9.4 mm | max. 9.4 mm | max. 9.4 mm | 4.5 - 5.0 mm | 5 - 10 mm |
| Abutment<br>Height | 5.0 - 12.3 mm | 3.0 - 7.5 mm | max 12.45 mm | max 12.45 mm | max 12.45 mm | 2.0 - 5.5 mm | 3.0 - 7.5 mm |
| Abutment<br>fixation | Abutment<br>Screw | Abutment<br>Screw | Abutment<br>Screw | Abutment<br>Screw | Abutment<br>Screw | Abutment<br>Screw | Abutment<br>Screw |
| CAD/CAM<br>Processing | Milled in Biodenta<br>milling center<br>under QSR control | Milled in Biodenta<br>milling center under<br>QSR control | Milled in manufact.<br>milling center under<br>QSR control | Milled in manufact.<br>milling center under<br>QSR control | Milled in manufact.<br>milling center under<br>QSR control | NA | Milled in manufact.<br>milling center under<br>QSR control |

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Image /page/8/Picture/1 description: The image shows the logo for "biodenta". The logo features the word "biodenta" in gray, with a stylized graphic above it. The graphic consists of two curved shapes, one in light gray and the other in light green, positioned to suggest movement or growth.

| | Subject Device | Primary Predicate | Reference Predicates | | | | | |
|---------------------|--------------------------------------------------|---------------------------------|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|-----------------------------------|--|
| Company | Biodenta Swiss AG | Biodenta Swiss AG | Prismark<br>Dentalcraft, Inc | Prismark<br>Dentalcraft, Inc | Prismark<br>Dentalcraft, Inc | Biodenta Swiss<br>AG | Pou Yu Biotechnology<br>Co., Ltd. | |
| Device<br>Name | Biodenta<br>Customised<br>Abutment -<br>Titanium | Biodenta Customized<br>Abutment | Inclusive Titanium<br>Abutments For Astra<br>Tech Osseospeed<br>Implants | Inclusive® Titanium<br>Abutments compatible<br>with: Straumann Bone<br>Level, Nobel Biocare<br>Branemark , and Nobel<br>Biocare NobelActive<br>Implants | Inclusive® Titanium<br>Abutments, compatible<br>with Zimmer Screw-<br>Vent, Biomet 3i Certain,<br>and Nobel Biocare<br>NobelReplace Implants | Biodenta<br>Dental Implant<br>System - Multi-<br>Use Abutment | TDS Abutment for<br>Friadent Xive | |
| 510(k)<br>Number | New device | K110778 | K100993 | K142118 | K142115 | K123491 | K103339 | |
| Material | | | | | | | | |
| Abutment +<br>Screw | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | |
| Sterile / Reuse | | | | | | | | |
| Sterile | Delivered Non<br>Sterile | Delivered Non<br>Sterile | Delivered Non<br>Sterile | Delivered Non<br>Sterile | Delivered Non<br>Sterile | Delivered Non<br>Sterile | Delivered Non<br>Sterile | |
| Reusable | no | no | no | no | no | no | no | |

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Image /page/9/Picture/1 description: The image shows the logo for Biodenta. The logo consists of the word "biodenta" in gray, with a registered trademark symbol to the right of the word. Above the word is a curved shape that is gray on top and light green on the bottom.

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