Predicate Devices

K110778, K100993, K142118, K142115, K123491

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the material, manufacturing process (CAD and milling), and mechanical testing of a customized dental abutment. There is no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

No
The device is described as a support for prostheses, not as one that provides therapy or treatment itself.

Diagnostic

No

Explanation: The device is an abutment for dental implants, designed to support prostheses. Its function is structural and restorative, not diagnostic.

SaMD (Software as a Medical Device)

No

The device is a physical dental abutment made of titanium, designed using CAD software but ultimately a manufactured hardware component.

IVD (In Vitro Diagnostic)

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 for supporting dental prostheses in the maxilla or mandible of a patient. This is a direct clinical application within the body.
Device Description: The description details a physical implant component made of titanium, designed to be placed within the patient's mouth.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.

IVD devices are used outside the body to analyze samples for diagnostic purposes. This device is a medical device intended for surgical implantation and support of dental prostheses within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Following is the extracted information from the provided FDA summary:

Intended Use / 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:

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

Product codes

NHA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

maxilla or mandible

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dental technician (for design using CAD software), laboratory (for final restoration), dentist

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K110778, K100993, K142118, K142115, K123491

Reference Device(s)

K103339

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.)

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

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.

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 (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 (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 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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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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
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:	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
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:
Straumann Bone Level, Nobel Biocare Branemark, and
Nobel Biocare NobelActive Implants
510(k) number:	K142118
4. Company:	Prismark Dentalcraft, Inc
Device name:	Inclusive® Titanium Abutments, compatible with Zimmer
Screw- Vent, Biomet 3i Certain, and Nobel Biocare
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;
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

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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
Dentalcraft, Inc	Prismark
Dentalcraft, Inc	Prismark
Dentalcraft, Inc	Biodenta Swiss
AG	Pou Yu Biotechnology
Co., Ltd.
Device
Name	Biodenta
Customised
Abutment -
Titanium	Biodenta Customized
Abutment	Inclusive Titanium
Abutments For Astra
Tech Osseospeed
Implants	Inclusive® Titanium
Abutments compatible
with: Straumann Bone
Level, Nobel Biocare
Branemark , and Nobel
Biocare NobelActive
Implants	Inclusive® Titanium
Abutments, compatible
with Zimmer Screw-
Vent, Biomet 3i Certain,
and Nobel Biocare
NobelReplace Implants	Biodenta
Dental Implant
System - Multi-
Use Abutment	TDS Abutment for
Friadent Xive
510(k)
Number	New device	K110778	K100993	K142118	K142115	K123491	K103339
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 intended for
use with dental implants as
a support for single or multi
ple tooth prostheses in the
maxilla or mandible of a par
tially or fully edentulous pat
ient. The Biodenta Custom
ized Abutment is compatible
with the following implant
systems: - Internal hex sys
tems with flat-to-flat dimen
sions of 1.78mm or greater:
Firadent: FRIALIT Implant,
XiVA Implant: 3i: Certain Inte
rnal Connect Type; Astra:
Osseospeed Implant, Osseo
speed TX Implant; BioHoriz
ons: Internal Implant Syst
em, Tapered Internal Impl
ant System, Single-Stage
Implant System; Life core:
Lifecore RENOVA Internal
Hex Implant System; Zimm
er: Tapered Screw-Vent Imp
lant System, Screw-Vent Im
plant System, AdVent Impla
nt System. - Nobel Biocare
Replace: NobelReplace Stra
ight, NobelReplace Tapered
Replace Select Tapered, Re
place Select Straight; for the
NP,RP,WPand6.0 implants.

External hex systems with
flat-to-flat dimensions of 2.4
mm or greater:Nobel Bioca | The InclusiveO
Titanium Abutments
for Astra
OsseoSpeed’M
Implants are
premanufactured
prosthetic
components directly
connected to
endlosseous dental
implants and are
intended
for use as an aid in
prosthetic
rehabilitation. They
are compatible with
the Astra Tech
OsseoSpeed" 3.0,
3.5, 4.0, 4.5, 5.0
implants. | Inclusive® Titanium
Abutments are
premanufactured
prosthetic
components directly
connected to
endosseous dental
implants and are
intended for use as
an aid in prosthetic
rehabilitation.
Inclusive® Titanium
Abutments are
compatible with:
Straumann: Bone
Level NC and RC
implant sizes
Nobel Biocare:
Branemark RP size
implant
Nobel Biocare
NobelActive NP and
RP internal
connection implants | Inclusive® Titanium
Abutments are
premanufactured
prosthetic components
directly connected to
endosseous dental
implants and are
intended for use as an
aid in prosthetic
rehabilitation.
Inclusive® Titanium
Abutments are
compatible with:
Biomet: 3i Certain
internal hex implants in
3.4, 4.1, 5.0, 6.0 mm
sizes
Nobel Biocare:
NobelReplace straight
and tapered internal
connection
implants in NP, RP, WP,
6.0 mm sizes
Zimmer: Screw-Vent
and Tapered Screw-
Vent internal hex
implants in 3.5,
4.5, 5.7 mm sizes | Biodenta
Dental Implant
System Multi
Use Abutments
are intended for
terminal or
intermediate
abutment
support for
fixed or
removable
crown,
bridgework and
to retain
overdentures. | TDS Abutment for Friadent
Xive 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.
This device is compatible
with the following implant
systems which have an
internal hex with flat-to-flat
dimensions of 1.78mm or
greater: Firadent: FRIALIT
Implant, XiVA Implant; 3i:
Internal Connect Type;
Astra: Osseoispeed
Implant, Osseospeed TX
Implant; BioHorizons:
Internal Implant System,
Tapered Internal Implant
System, Single-Stage
Implant System, Laser-
lok®&3.0 implant system;
Lifecore: , Lifecore:
RENOVATM Internal Hex
Implant System; Zimmer:
Tapered Screw-Vent
Implant System, Screw-
Vent Implant System,
AdVent Implant System;
Osstem: GS System;
Nobel Biocare: Active
Implant. |
| | Subject Device | Primary Predicate | Reference Predicates | | | | |
| Company | Biodenta Swiss AG | Biodenta Swiss AG | Prismark
Dentalcraft, Inc | Prismark
Dentalcraft, Inc | Biodenta Swiss
AG | Pou Yu Biotechnology
Co., Ltd. | |
| Device
Name | Biodenta
Customised
Abutment -
Titanium | Biodenta Customized
Abutment | Inclusive Titanium
Abutments For Astra
Tech Osseospeed
Implants | Inclusive® Titanium
Abutments, compatible
with: Straumann Bone
Level, Nobel Biocare
Branemark , and Nobel
Biocare NobelActive
Implants | Biodenta
Dental Implant
System - Multi-
Use Abutment | TDS Abutment for
Friadent Xive | |
| 510(k)
Number | New device | K110778 | K100993 | K142118 | K123491 | K103339 | |
| Compatibl
e implant
types | - Dentsply, AstraTech
OsseoSpeed
Biomet 3i, Certain
Internal
Zimmer, Screw Vent
Nobel Biocare,
NobelReplace
Nobel Biocare,
NobelActive
Straumann, Bone
Level
BioHorizons, Internal
Osstem, GS/TS
Biodenta, Bone Level
and Tapered | - Dentsply, AstraTech
OsseoSpeed
Biomet 3i, Certain
Internal
Zimmer, Screw Vent
Nobel Biocare,
NobelReplace
Nobel Biocare,
NobelActive
Straumann, Bone
Level | - Dentsply, AstraTech
OsseoSpeed | - Nobel Biocare,
NobelActive
Straumann, Bone
Level
Biomet: 3i Certain
internal
Zimmer: Screw-Vent
Nobel Biocare:
NobelReplace | - Biodenta, Bone
Level and Tapered | - Dentsply, AstraTech
OsseoSpeed
Biomet 3i, Certain
Internal
Zimmer, Screw Vent
Nobel Biocare,
NobelReplace
Nobel Biocare,
NobelActive
Straumann, Bone
Level
BioHorizons, Internal
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
Abutment

Angulation	30°	30°	30°	30°	30°	30°	30°
Abutment
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
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
fixation	Abutment
Screw	Abutment
Screw	Abutment
Screw	Abutment
Screw	Abutment
Screw	Abutment
Screw	Abutment
Screw
CAD/CAM
Processing	Milled in Biodenta
milling center
under QSR control	Milled in Biodenta
milling center under
QSR control	Milled in manufact.
milling center under
QSR control	Milled in manufact.
milling center under
QSR control	Milled in manufact.
milling center under
QSR control	NA	Milled in manufact.
milling center under
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
Dentalcraft, Inc	Prismark
Dentalcraft, Inc	Prismark
Dentalcraft, Inc	Biodenta Swiss
AG	Pou Yu Biotechnology
Co., Ltd.
Device
Name	Biodenta
Customised
Abutment -
Titanium	Biodenta Customized
Abutment	Inclusive Titanium
Abutments For Astra
Tech Osseospeed
Implants	Inclusive® Titanium
Abutments compatible
with: Straumann Bone
Level, Nobel Biocare
Branemark , and Nobel
Biocare NobelActive
Implants	Inclusive® Titanium
Abutments, compatible
with Zimmer Screw-
Vent, Biomet 3i Certain,
and Nobel Biocare
NobelReplace Implants	Biodenta
Dental Implant
System - Multi-
Use Abutment	TDS Abutment for
Friadent Xive
510(k)
Number	New device	K110778	K100993	K142118	K142115	K123491	K103339
Material
Abutment +
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
Sterile	Delivered Non
Sterile	Delivered Non
Sterile	Delivered Non
Sterile	Delivered Non
Sterile	Delivered Non
Sterile	Delivered Non
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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